Bruce Jancin

Major Finding: Football had a concussion incidence of 0.6 cases per 1,000 athletic games or practices. The sport with the second highest incidence was girls' soccer, at 0.35 per 1,000 athletic exposures.

Data Source: A retrospective analysis of all 2,479 observed concussions during nearly 11 million athletic games or practices in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008.

Disclosures: The study was financially supported by the U.S. Lacrosse Sports Science and Safety Committee. Dr. Lincoln declared having no relevant financial interests.

DENVER – High school girls have twice the concussion rate of boys playing similar sports, according to an 11-year study conducted in a large public school district.

Not surprisingly, football accounted for the most concussions among participants in the six boys' and six girls' sports examined in the long-term study. But the sport with the second-highest concussion rate was girls' soccer, classified as an incidental contact sport rather than a collision sport, Andrew E. Lincoln, Sc.D., said at the meeting.

He presented a retrospective study of all concussions occurring in athletes participating in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008. This suburban Washington school district was the ideal location for such a study because as a matter of district policy a certified athletic trainer was on site for all games and practices, and all injuries – big or small – had to be logged electronically on a daily basis, explained Dr. Lincoln of the sports medicine research center at Union Memorial Hospital, Baltimore.

During the study period, there were 2,479 observed concussions during nearly 11 million athletic exposures. An athletic exposure was defined as a game or practice. Football led the way, accounting for 53% of all concussions. The other boys' sports included in the study were lacrosse, soccer, wrestling, basketball, and baseball. The girls' sports were soccer, which accounted for 7% of all concussions among high school athletes, along with lacrosse, basketball, softball, field hockey, and cheerleading. Another 15 sports are offered in the school district, but they account for relatively few concussions.

Seventy-five percent of all concussions occurred in boys' sports, which accounted for 53% of athletic exposures. “In terms of who walks in the door to the athletic trainer's room with a concussion, it's a 3-to-1 ratio of boys to girls,” Dr. Lincoln observed.

Football had a concussion incidence of 0.6 cases per 1,000 athletic exposures. This was followed by girls' soccer, at 0.35 per 1,000 athletic exposures, and boys' lacrosse, at 0.30 per 1,000. Baseball and cheerleading had the lowest rates at 0.06 per 1,000. That means the incidence of concussion was 10.9-fold greater in football than in baseball, and 6-fold more in girls' soccer than in cheerleading.

Although cheerleading had the lowest concussion incidence among girls' sports, it accounted for 5% of all athletic concussions, putting it in a fourth-place tie with wrestling for that dubious distinction.

In the three sports that are closely similar for boys and girls – basketball, soccer, and baseball/softball – the concussion rate was consistently twice as great for girls. This gender disparity has previously been described at the collegiate level, but this is the first study to demonstrate the same phenomenon at the high school level, according to the researcher.

While both boys and girls play high school lacrosse, these are two very different sports. In boys' lacrosse, it's a full-on collision sport, helmets and pads required. For girls it's an incidental contact sport requiring only protective eye wear.

The concussion rate in the school district increased by an average of 16.5% annually during the study period for a 4.6-fold jump between 1997 and 2008. The increase was seen in all 12 sports. Football had the smallest annual increase rate, at 8%, while concussions in cheerleaders jumped by 26% per year and in wrestlers by 27% annually.

“The major concerns are football, girls' soccer, and boys' lacrosse. However, the increasing incidence across all sports suggests the focus on concussion detection, treatment, and prevention should not be limited to those sports traditionally associated with concussion risk,” according to Dr. Lincoln.

It's unclear whether the explanation for the marked rise in concussion incidence over time is that sports have gotten more aggressive, or coding and diagnosis have improved. Most likely the answer lies in a combination of both, he said.

Why the markedly higher concussion risk in girls compared with boys playing the same sports? Dr. Lincoln said other investigators have put forth three hypotheses. One is that boys' greater muscle mass can absorb more of the impact energy that would otherwise be transferred to the brain. Another possibility is that girls might be culturally more willing to report injuries and seek care. And perhaps hormonal differences are at work as well; studies have shown that girls take longer to recover from concussions.

Governing bodies for professional and amateur sports are now taking concussions and their potential long-term sequelae far more seriously than even a few years ago, Dr. Lincoln said.

“I think if we look at this in terms of any other public health issue we would all be pretty outraged, so I'm kind of glad to see the outrage in society right now, and the movement on policy issues as well,” he said.

The concussion rate was consistently twice as great for girls in basketball, soccer, and baseball/softball.

Source DR. LINCOLN

Major Finding: Football had a concussion incidence of 0.6 cases per 1,000 athletic games or practices. The sport with the second highest incidence was girls' soccer, at 0.35 per 1,000 athletic exposures.

Data Source: A retrospective analysis of all 2,479 observed concussions during nearly 11 million athletic games or practices in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008.

Disclosures: The study was financially supported by the U.S. Lacrosse Sports Science and Safety Committee. Dr. Lincoln declared having no relevant financial interests.

DENVER – High school girls have twice the concussion rate of boys playing similar sports, according to an 11-year study conducted in a large public school district.

Not surprisingly, football accounted for the most concussions among participants in the six boys' and six girls' sports examined in the long-term study. But the sport with the second-highest concussion rate was girls' soccer, classified as an incidental contact sport rather than a collision sport, Andrew E. Lincoln, Sc.D., said at the meeting.

He presented a retrospective study of all concussions occurring in athletes participating in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008. This suburban Washington school district was the ideal location for such a study because as a matter of district policy a certified athletic trainer was on site for all games and practices, and all injuries – big or small – had to be logged electronically on a daily basis, explained Dr. Lincoln of the sports medicine research center at Union Memorial Hospital, Baltimore.

During the study period, there were 2,479 observed concussions during nearly 11 million athletic exposures. An athletic exposure was defined as a game or practice. Football led the way, accounting for 53% of all concussions. The other boys' sports included in the study were lacrosse, soccer, wrestling, basketball, and baseball. The girls' sports were soccer, which accounted for 7% of all concussions among high school athletes, along with lacrosse, basketball, softball, field hockey, and cheerleading. Another 15 sports are offered in the school district, but they account for relatively few concussions.

Seventy-five percent of all concussions occurred in boys' sports, which accounted for 53% of athletic exposures. “In terms of who walks in the door to the athletic trainer's room with a concussion, it's a 3-to-1 ratio of boys to girls,” Dr. Lincoln observed.

Football had a concussion incidence of 0.6 cases per 1,000 athletic exposures. This was followed by girls' soccer, at 0.35 per 1,000 athletic exposures, and boys' lacrosse, at 0.30 per 1,000. Baseball and cheerleading had the lowest rates at 0.06 per 1,000. That means the incidence of concussion was 10.9-fold greater in football than in baseball, and 6-fold more in girls' soccer than in cheerleading.

Although cheerleading had the lowest concussion incidence among girls' sports, it accounted for 5% of all athletic concussions, putting it in a fourth-place tie with wrestling for that dubious distinction.

In the three sports that are closely similar for boys and girls – basketball, soccer, and baseball/softball – the concussion rate was consistently twice as great for girls. This gender disparity has previously been described at the collegiate level, but this is the first study to demonstrate the same phenomenon at the high school level, according to the researcher.

While both boys and girls play high school lacrosse, these are two very different sports. In boys' lacrosse, it's a full-on collision sport, helmets and pads required. For girls it's an incidental contact sport requiring only protective eye wear.

The concussion rate in the school district increased by an average of 16.5% annually during the study period for a 4.6-fold jump between 1997 and 2008. The increase was seen in all 12 sports. Football had the smallest annual increase rate, at 8%, while concussions in cheerleaders jumped by 26% per year and in wrestlers by 27% annually.

“The major concerns are football, girls' soccer, and boys' lacrosse. However, the increasing incidence across all sports suggests the focus on concussion detection, treatment, and prevention should not be limited to those sports traditionally associated with concussion risk,” according to Dr. Lincoln.

It's unclear whether the explanation for the marked rise in concussion incidence over time is that sports have gotten more aggressive, or coding and diagnosis have improved. Most likely the answer lies in a combination of both, he said.

Why the markedly higher concussion risk in girls compared with boys playing the same sports? Dr. Lincoln said other investigators have put forth three hypotheses. One is that boys' greater muscle mass can absorb more of the impact energy that would otherwise be transferred to the brain. Another possibility is that girls might be culturally more willing to report injuries and seek care. And perhaps hormonal differences are at work as well; studies have shown that girls take longer to recover from concussions.

Governing bodies for professional and amateur sports are now taking concussions and their potential long-term sequelae far more seriously than even a few years ago, Dr. Lincoln said.

“I think if we look at this in terms of any other public health issue we would all be pretty outraged, so I'm kind of glad to see the outrage in society right now, and the movement on policy issues as well,” he said.

The concussion rate was consistently twice as great for girls in basketball, soccer, and baseball/softball.

Source DR. LINCOLN

Major Finding: Football had a concussion incidence of 0.6 cases per 1,000 athletic games or practices. The sport with the second highest incidence was girls' soccer, at 0.35 per 1,000 athletic exposures.

Data Source: A retrospective analysis of all 2,479 observed concussions during nearly 11 million athletic games or practices in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008.

Disclosures: The study was financially supported by the U.S. Lacrosse Sports Science and Safety Committee. Dr. Lincoln declared having no relevant financial interests.

DENVER – High school girls have twice the concussion rate of boys playing similar sports, according to an 11-year study conducted in a large public school district.

Not surprisingly, football accounted for the most concussions among participants in the six boys' and six girls' sports examined in the long-term study. But the sport with the second-highest concussion rate was girls' soccer, classified as an incidental contact sport rather than a collision sport, Andrew E. Lincoln, Sc.D., said at the meeting.

He presented a retrospective study of all concussions occurring in athletes participating in 12 sports at 25 high schools in Fairfax County, Va., during 1997-2008. This suburban Washington school district was the ideal location for such a study because as a matter of district policy a certified athletic trainer was on site for all games and practices, and all injuries – big or small – had to be logged electronically on a daily basis, explained Dr. Lincoln of the sports medicine research center at Union Memorial Hospital, Baltimore.

During the study period, there were 2,479 observed concussions during nearly 11 million athletic exposures. An athletic exposure was defined as a game or practice. Football led the way, accounting for 53% of all concussions. The other boys' sports included in the study were lacrosse, soccer, wrestling, basketball, and baseball. The girls' sports were soccer, which accounted for 7% of all concussions among high school athletes, along with lacrosse, basketball, softball, field hockey, and cheerleading. Another 15 sports are offered in the school district, but they account for relatively few concussions.

Seventy-five percent of all concussions occurred in boys' sports, which accounted for 53% of athletic exposures. “In terms of who walks in the door to the athletic trainer's room with a concussion, it's a 3-to-1 ratio of boys to girls,” Dr. Lincoln observed.

Football had a concussion incidence of 0.6 cases per 1,000 athletic exposures. This was followed by girls' soccer, at 0.35 per 1,000 athletic exposures, and boys' lacrosse, at 0.30 per 1,000. Baseball and cheerleading had the lowest rates at 0.06 per 1,000. That means the incidence of concussion was 10.9-fold greater in football than in baseball, and 6-fold more in girls' soccer than in cheerleading.

Although cheerleading had the lowest concussion incidence among girls' sports, it accounted for 5% of all athletic concussions, putting it in a fourth-place tie with wrestling for that dubious distinction.

In the three sports that are closely similar for boys and girls – basketball, soccer, and baseball/softball – the concussion rate was consistently twice as great for girls. This gender disparity has previously been described at the collegiate level, but this is the first study to demonstrate the same phenomenon at the high school level, according to the researcher.

While both boys and girls play high school lacrosse, these are two very different sports. In boys' lacrosse, it's a full-on collision sport, helmets and pads required. For girls it's an incidental contact sport requiring only protective eye wear.

The concussion rate in the school district increased by an average of 16.5% annually during the study period for a 4.6-fold jump between 1997 and 2008. The increase was seen in all 12 sports. Football had the smallest annual increase rate, at 8%, while concussions in cheerleaders jumped by 26% per year and in wrestlers by 27% annually.

“The major concerns are football, girls' soccer, and boys' lacrosse. However, the increasing incidence across all sports suggests the focus on concussion detection, treatment, and prevention should not be limited to those sports traditionally associated with concussion risk,” according to Dr. Lincoln.

It's unclear whether the explanation for the marked rise in concussion incidence over time is that sports have gotten more aggressive, or coding and diagnosis have improved. Most likely the answer lies in a combination of both, he said.

Why the markedly higher concussion risk in girls compared with boys playing the same sports? Dr. Lincoln said other investigators have put forth three hypotheses. One is that boys' greater muscle mass can absorb more of the impact energy that would otherwise be transferred to the brain. Another possibility is that girls might be culturally more willing to report injuries and seek care. And perhaps hormonal differences are at work as well; studies have shown that girls take longer to recover from concussions.

Governing bodies for professional and amateur sports are now taking concussions and their potential long-term sequelae far more seriously than even a few years ago, Dr. Lincoln said.

“I think if we look at this in terms of any other public health issue we would all be pretty outraged, so I'm kind of glad to see the outrage in society right now, and the movement on policy issues as well,” he said.

The concussion rate was consistently twice as great for girls in basketball, soccer, and baseball/softball.

Source DR. LINCOLN

DENVER – Eating more frequently conferred less risk of excessive weight gain over the course of a decade among teenage girls participating in a large longitudinal study.

This finding lays the groundwork for intervention trials designed to learn whether changing eating frequency or the size of eating episodes alters obesity risk in young people, Lorrene D. Ritchie, Ph.D., observed at the annual meeting of the American Public Health Association.

She reported on 1,213 black and 1,166 white girls tracked prospectively from ages 9-10 years to 19-20 years in the National Heart, Lung, and Blood Institute (NHLBI) Growth and Health Study. Detailed 3-day diet record data were collected from participants on an annual basis.

Mean daily eating frequency during the 10-year study period was 2.57 meals and 1.67 snacks. A meal was defined as any eating episode involving consumption of at least 15% of total daily calories. All other eating episodes counted as snacks, explained Dr. Ritchie, director of research at the Atkins Center for Weight and Health at the University of California, Berkeley.

Eating frequency was greater when girls were younger, in whites as compared with blacks, and on weekdays rather than weekends.

Not surprisingly, the more times girls ate during the course of a day, the higher their caloric intake. But upon statistical adjustment for caloric intake, white girls who ate more frequently had significantly lower consumption of total fat, saturated fat, and sodium, and more intake of dietary fiber than did girls who ate less often. Among black teens the relationship was more variable.

For girls of both races, greater eating frequency – especially snacking – was paradoxically associated with significantly less 10-year gain in both body mass index and waist circumference after researchers adjusted for race, physical activity, hours of TV viewing, and parental education.

Few prior studies have investigated the relationship between frequency of eating and obesity in children. Two national cross-sectional studies found no relationship at all. One prior longitudinal study found an inverse relationship between eating frequency and adiposity, as seen in the NHLBI Growth and Health Study, but another longitudinal study showed a positive relationship between eating frequency and obesity. However, it’s tough to interpret the literature in this area because prior investigators used vague or inconsistent definitions of what constitutes meals and snacks. One strength of the Growth and Health Study is that it used objective definitions, Dr. Ritchie noted.

Her analysis was supported by a grant from the U.S. Department of Agriculture. She declared having no relevant financial relationships.

DENVER – Eating more frequently conferred less risk of excessive weight gain over the course of a decade among teenage girls participating in a large longitudinal study.

This finding lays the groundwork for intervention trials designed to learn whether changing eating frequency or the size of eating episodes alters obesity risk in young people, Lorrene D. Ritchie, Ph.D., observed at the annual meeting of the American Public Health Association.

She reported on 1,213 black and 1,166 white girls tracked prospectively from ages 9-10 years to 19-20 years in the National Heart, Lung, and Blood Institute (NHLBI) Growth and Health Study. Detailed 3-day diet record data were collected from participants on an annual basis.

Mean daily eating frequency during the 10-year study period was 2.57 meals and 1.67 snacks. A meal was defined as any eating episode involving consumption of at least 15% of total daily calories. All other eating episodes counted as snacks, explained Dr. Ritchie, director of research at the Atkins Center for Weight and Health at the University of California, Berkeley.

Eating frequency was greater when girls were younger, in whites as compared with blacks, and on weekdays rather than weekends.

Not surprisingly, the more times girls ate during the course of a day, the higher their caloric intake. But upon statistical adjustment for caloric intake, white girls who ate more frequently had significantly lower consumption of total fat, saturated fat, and sodium, and more intake of dietary fiber than did girls who ate less often. Among black teens the relationship was more variable.

For girls of both races, greater eating frequency – especially snacking – was paradoxically associated with significantly less 10-year gain in both body mass index and waist circumference after researchers adjusted for race, physical activity, hours of TV viewing, and parental education.

Few prior studies have investigated the relationship between frequency of eating and obesity in children. Two national cross-sectional studies found no relationship at all. One prior longitudinal study found an inverse relationship between eating frequency and adiposity, as seen in the NHLBI Growth and Health Study, but another longitudinal study showed a positive relationship between eating frequency and obesity. However, it’s tough to interpret the literature in this area because prior investigators used vague or inconsistent definitions of what constitutes meals and snacks. One strength of the Growth and Health Study is that it used objective definitions, Dr. Ritchie noted.

Her analysis was supported by a grant from the U.S. Department of Agriculture. She declared having no relevant financial relationships.

DENVER – Eating more frequently conferred less risk of excessive weight gain over the course of a decade among teenage girls participating in a large longitudinal study.

This finding lays the groundwork for intervention trials designed to learn whether changing eating frequency or the size of eating episodes alters obesity risk in young people, Lorrene D. Ritchie, Ph.D., observed at the annual meeting of the American Public Health Association.

She reported on 1,213 black and 1,166 white girls tracked prospectively from ages 9-10 years to 19-20 years in the National Heart, Lung, and Blood Institute (NHLBI) Growth and Health Study. Detailed 3-day diet record data were collected from participants on an annual basis.

Mean daily eating frequency during the 10-year study period was 2.57 meals and 1.67 snacks. A meal was defined as any eating episode involving consumption of at least 15% of total daily calories. All other eating episodes counted as snacks, explained Dr. Ritchie, director of research at the Atkins Center for Weight and Health at the University of California, Berkeley.

Eating frequency was greater when girls were younger, in whites as compared with blacks, and on weekdays rather than weekends.

Not surprisingly, the more times girls ate during the course of a day, the higher their caloric intake. But upon statistical adjustment for caloric intake, white girls who ate more frequently had significantly lower consumption of total fat, saturated fat, and sodium, and more intake of dietary fiber than did girls who ate less often. Among black teens the relationship was more variable.

For girls of both races, greater eating frequency – especially snacking – was paradoxically associated with significantly less 10-year gain in both body mass index and waist circumference after researchers adjusted for race, physical activity, hours of TV viewing, and parental education.

Few prior studies have investigated the relationship between frequency of eating and obesity in children. Two national cross-sectional studies found no relationship at all. One prior longitudinal study found an inverse relationship between eating frequency and adiposity, as seen in the NHLBI Growth and Health Study, but another longitudinal study showed a positive relationship between eating frequency and obesity. However, it’s tough to interpret the literature in this area because prior investigators used vague or inconsistent definitions of what constitutes meals and snacks. One strength of the Growth and Health Study is that it used objective definitions, Dr. Ritchie noted.

Her analysis was supported by a grant from the U.S. Department of Agriculture. She declared having no relevant financial relationships.

DENVER – Individuals with a diagnosis of depression or anxiety are significantly more likely to have gone more than a year since their last visit to a dentist, Catherine A. Okoro reported at the annual meeting of the American Public Health Association.

Moreover, among both men and women in the general public, the extent of tooth loss was directly correlated with the prevalence of depression or lifetime diagnosed depression or anxiety, added Ms. Okoro, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta.

She presented a study involving 96,269 men and 150,606 women who participated in the CDC’s Behavioral Risk Factor Surveillance System telephone surveys conducted in 2006 and 2008. The prevalence of current depression as assessed using the Patient Health Questionnaire-8 was 6.4% among men and 10.1% in women. Among men, 10.8% had a past or current diagnosis of depression, as did 20.3% of women. A lifetime diagnosis of anxiety was present in 8.2% of men and 14.6% of women.

Overall, 7.4% of American adults participating in the nationally representative survey had no teeth. Of those with teeth, 51.9% of respondents had all their teeth, 33.5% were missing 1-5 teeth, and 14.6% were missing 6-31 teeth.

After researchers adjusted for numerous potential confounding variables, men with missing teeth were significantly more likely to have current depression or lifetime diagnosed anxiety than were those with all their teeth. Paradoxically, men with complete tooth loss were significantly less likely than those with no lost teeth to have lifetime diagnosed depression. Women with tooth loss also were significantly more likely to have current depression.

Women who had not received oral health services in the past year were an adjusted 29% more likely to have current depression than those who had. The adjusted 12% increased likelihood of current depression in men who hadn’t been to a dentist within the prior year didn’t achieve statistical significance, though.

The take-away message is the importance of encouraging patients with depression or anxiety to visit a dental health professional, Ms. Okoro stressed.

She declared having no relevant financial interests.

DENVER – Individuals with a diagnosis of depression or anxiety are significantly more likely to have gone more than a year since their last visit to a dentist, Catherine A. Okoro reported at the annual meeting of the American Public Health Association.

Moreover, among both men and women in the general public, the extent of tooth loss was directly correlated with the prevalence of depression or lifetime diagnosed depression or anxiety, added Ms. Okoro, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta.

She presented a study involving 96,269 men and 150,606 women who participated in the CDC’s Behavioral Risk Factor Surveillance System telephone surveys conducted in 2006 and 2008. The prevalence of current depression as assessed using the Patient Health Questionnaire-8 was 6.4% among men and 10.1% in women. Among men, 10.8% had a past or current diagnosis of depression, as did 20.3% of women. A lifetime diagnosis of anxiety was present in 8.2% of men and 14.6% of women.

Overall, 7.4% of American adults participating in the nationally representative survey had no teeth. Of those with teeth, 51.9% of respondents had all their teeth, 33.5% were missing 1-5 teeth, and 14.6% were missing 6-31 teeth.

After researchers adjusted for numerous potential confounding variables, men with missing teeth were significantly more likely to have current depression or lifetime diagnosed anxiety than were those with all their teeth. Paradoxically, men with complete tooth loss were significantly less likely than those with no lost teeth to have lifetime diagnosed depression. Women with tooth loss also were significantly more likely to have current depression.

Women who had not received oral health services in the past year were an adjusted 29% more likely to have current depression than those who had. The adjusted 12% increased likelihood of current depression in men who hadn’t been to a dentist within the prior year didn’t achieve statistical significance, though.

The take-away message is the importance of encouraging patients with depression or anxiety to visit a dental health professional, Ms. Okoro stressed.

She declared having no relevant financial interests.

DENVER – Individuals with a diagnosis of depression or anxiety are significantly more likely to have gone more than a year since their last visit to a dentist, Catherine A. Okoro reported at the annual meeting of the American Public Health Association.

Moreover, among both men and women in the general public, the extent of tooth loss was directly correlated with the prevalence of depression or lifetime diagnosed depression or anxiety, added Ms. Okoro, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta.

She presented a study involving 96,269 men and 150,606 women who participated in the CDC’s Behavioral Risk Factor Surveillance System telephone surveys conducted in 2006 and 2008. The prevalence of current depression as assessed using the Patient Health Questionnaire-8 was 6.4% among men and 10.1% in women. Among men, 10.8% had a past or current diagnosis of depression, as did 20.3% of women. A lifetime diagnosis of anxiety was present in 8.2% of men and 14.6% of women.

Overall, 7.4% of American adults participating in the nationally representative survey had no teeth. Of those with teeth, 51.9% of respondents had all their teeth, 33.5% were missing 1-5 teeth, and 14.6% were missing 6-31 teeth.

After researchers adjusted for numerous potential confounding variables, men with missing teeth were significantly more likely to have current depression or lifetime diagnosed anxiety than were those with all their teeth. Paradoxically, men with complete tooth loss were significantly less likely than those with no lost teeth to have lifetime diagnosed depression. Women with tooth loss also were significantly more likely to have current depression.

Women who had not received oral health services in the past year were an adjusted 29% more likely to have current depression than those who had. The adjusted 12% increased likelihood of current depression in men who hadn’t been to a dentist within the prior year didn’t achieve statistical significance, though.

The take-away message is the importance of encouraging patients with depression or anxiety to visit a dental health professional, Ms. Okoro stressed.

She declared having no relevant financial interests.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

SAN ANTONIO – A reassuring message regarding the cardiovascular safety of adjuvant aromatase inhibitor therapy for early breast cancer is provided by a large, population-based study of patients who were treated in real-world community settings rather than in the rarified world of randomized clinical trials.

The case-control study included 44,463 women diagnosed with early breast cancer in 2001-2007 and an equal number of closely matched controls obtained from a database of 30 million privately insured individuals, Dr. Jennifer A. Ligibel explained at the San Antonio Breast Cancer Symposium.

The study was undertaken because randomized trials tend to enroll a younger and otherwise healthier population of breast cancer patients than those encountered in community practice. Plus, the randomized trials nearly always compare aromatase inhibitors (AIs) vs. tamoxifen, making it difficult to sort out whether the increased risk of cardiovascular disease that is often reported with AIs in the randomized trials is a true drug side effect, or is instead due to a possible cardioprotective effect of tamoxifen, noted Dr. Ligibel of Harvard Medical School, Boston.

During the study period, 16% of the breast cancer patients filled prescriptions for an AI, 11% for tamoxifen, and 5% for both.

With a mean follow-up of about 1,000 days, 1.3% of the nearly 90,000 women in the case-control study had an MI, 2.9% had an ischemic stroke, 1.5% had a hip fracture, and 9.5% had any fracture.

The study showed a substantial reduction in the adjusted risks of ischemic stroke (P = .03) and hip fracture (P = .005) in tamoxifen-treated patients, compared with breast cancer patients who were not on either tamoxifen or an AI.

The AI-treated patients also had a significant reduction in risk of stroke (P = .004), compared with breast cancer patients who were on no endocrine treatment.

The AI-treated women had an adjusted risk of hip fracture that was similar to that in breast cancer patients on no endocrine treatment and in controls. However, the adjusted risk of all fractures was significantly greater in women who were on an AI than in breast cancer patients on no treatment (P = .02).

Intriguingly, breast cancer patients who were not on tamoxifen or an aromatase inhibitor had significantly lower risks of MI (P = .003) and all fractures (P less than .001) than were matched controls without breast cancer. This novel observation warrants further study, Dr. Ligibel continued.

Because patients on an AI had a slightly – but not significantly – lower risk of MI than did breast cancer patients not on endocrine therapy, the AI-treated women also had a significantly lower MI risk than did the controls without breast cancer.

The breast cancer patients and controls were exceptionally closely matched: The mean age was 67 years in both groups, 87% had no comorbidities, 38% in both groups were taking drugs from more than four classes, 21% were on statins, and 8% in both groups were on a proton pump inhibitor. In all, 84% of women in each group had a high school education. Mean household income in both groups was roughly $63,400 annually.

"This is basically reassuring," Dr. Alan Coates said of the Harvard findings in a conference-closing wrap-up of the year’s top developments in early breast cancer.

"What’s different about this one is it compares a baseline of breast cancer patients not receiving endocrine therapy," noted Dr. Coates of the University of Sydney. "The conclusions are quite different from those you would reach by looking at the randomized trials [that] looked at a comparison of an aromatase inhibitor vs. tamoxifen."

A meta-analysis of seven such randomized trials with follow-up of 28-100 months that was presented at the conference by Dr. Eitan Amir concluded that AI therapy was associated with a highly significant 26% increased risk of the combined cardiovascular end point comprising MI, heart failure, or angina, compared with tamoxifen therapy (P less than .001).

He noted that the absolute increase in risk associated with AIs was quite small (0.8% in excess of the 3.4% rate with tamoxifen). The number of women who would need to be treated with an AI instead of tamoxifen in order to have one additional patient experience a cardiovascular event was 132.

This small absolute risk may be magnified in women who are at increased cardiovascular risk. In 2008, the Food and Drug Administration ordered a black box warning for anastrozole (Arimidex) based upon data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study showing a 17% incidence of ischemic cardiovascular events with anastrozole in women with preexisting heart disease, compared with a 10% incidence with tamoxifen. ATAC was one of the randomized trials included in the new meta-analysis, noted Dr. Amir, a senior fellow in medical oncology and hematology at Princess Margaret Hospital, Toronto.

The risk of venous thromboembolism in the meta-analysis was 45% lower with AIs than tamoxifen (P less than .001). The absolute risk was 1.6% in the AI group, compared with 3.1% with tamoxifen, for a number-needed-to-harm of 69.

Fractures were consistently more common with AI therapy, with a 47% increased relative risk (P less than 0.001) and an absolute risk of 7.5% as compared to 5.2% with tamoxifen. The number-needed-to-harm via an AI was 46 patients.

There were no differences between the two groups in terms of cerebrovascular events or emergence of second cancers, with the exception of endometrial carcinoma, which was 66% less likely in the AI group and had a number-needed-to-harm of 250.

The risk of death unrelated to recurrent breast cancer was closely similar with AIs and tamoxifen. However, there was a strong trend for fewer deaths without recurrence in patients who underwent switching, either from an upfront AI to tamoxifen or vice versa.

"This suggests that there may be side effects that build up the longer a woman is on a certain drug, and therefore – and this is strictly hypothesis generating – that switching from one agent to another may be the best way to avoid these toxicities," Dr. Amir concluded.

Dr. Amir declared having no relevant financial interests. So did Dr. Ligibel, whose study was funded by the National Cancer Institute.

DENVER – A novel Massachusetts program of bystander-administered intranasal naloxone shows promise for the treatment of potentially fatal opioid overdoses.

The program was implemented in response to a greater than sixfold increase in the annual number of opioid-related fatal overdoses in Massachusetts from 1990 to 2006. Among 25- to 34-year-olds in Massachusetts, mortality attributable to opioid overdose is greater than that attributable to motor vehicle accidents, Courtney E. Pierce observed at the annual meeting of the American Public Health Association.

This is a national problem fostered by the ready availability of relatively low-cost, high-purity heroin along with the marked growth in opioid prescriptions, some of which are diverted for recreational use as street drugs. That’s why the Centers for Disease Control and Prevention is funding the ongoing 2-year Intranasal Naloxone and Prevention Education’s Effect on Overdose (INPEDE OD) study, The INPEDE OD study is comparing opioid overdose rates, fatal and nonfatal, in those high-risk Massachusetts communities that have implemented bystander-administered intranasal naloxone to rates in other high-risk communities that have not, explained Ms. Pierce of the section of general internal medicine at Boston Medical Center.

Bystander-given intranasal naloxone for reversal of opioid overdoses was implemented by the Boston Health Commission in August 2006. Based upon the favorable Boston experience over a 15-month period, the state health department implemented a structured program of overdose education and distribution of intranasal naloxone kits in seven additional sites across the state.

The program is implemented by community-based HIV risk-reduction programs or public health agencies. It entails 1 hour of training in how to recognize signs of overdose, administer intranasal naloxone, and contact emergency medical services. Participants are then given a two-dose kit and encouraged to keep it on their person.

To date nearly 8,000 potential bystanders have been enrolled. These are individuals considered particularly likely to encounter overdoses. They have been enrolled mostly at detox centers, methadone clinics, needle exchange sites, emergency departments, shelters, and drop-in centers. Among the enrollees are 5,351 individuals in treatment for, recovery from, or current active users of illicit drugs and 2,589 nonuser family members and professionals. At enrollment, 78% of people in the active- or past-use group and 47% of the nonusers had previously witnessed an overdose.

At last follow-up, 755 overdoses have been reversed through bystander-administered intranasal naloxone. In two-thirds of cases, the opioid antagonist was administered by a friend, in 14% by a partner or family member, and in 9% by a stranger. A total of 77% of these events took place in private settings. However, the bystander called 911 in only 34% of cases; this low rate is attributed to concern on the part of many bystanders that if they called the authorities, they risked arrest for illicit drug possession.

Naloxone is a Food and Drug Administration–approved drug with no abuse potential. Intranasal naloxone given as a spray via a mucosal atomizer is an off-label use. However, it’s easily administered and has been essentially problem free in the Massachusetts experience, according to Ms. Pierce.

The expectation is that the INPEDE OD study will demonstrate that bystander-administered intranasal naloxone saves lives and prevents trips to the emergency department. If so, the plan is to expand the number of participating sites and seek passage of a state Good Samaritan law providing bystanders with immunity from prosecution, she said.

Ms. Pierce declared she has no relevant financial interests.

DENVER – A novel Massachusetts program of bystander-administered intranasal naloxone shows promise for the treatment of potentially fatal opioid overdoses.

The program was implemented in response to a greater than sixfold increase in the annual number of opioid-related fatal overdoses in Massachusetts from 1990 to 2006. Among 25- to 34-year-olds in Massachusetts, mortality attributable to opioid overdose is greater than that attributable to motor vehicle accidents, Courtney E. Pierce observed at the annual meeting of the American Public Health Association.

This is a national problem fostered by the ready availability of relatively low-cost, high-purity heroin along with the marked growth in opioid prescriptions, some of which are diverted for recreational use as street drugs. That’s why the Centers for Disease Control and Prevention is funding the ongoing 2-year Intranasal Naloxone and Prevention Education’s Effect on Overdose (INPEDE OD) study, The INPEDE OD study is comparing opioid overdose rates, fatal and nonfatal, in those high-risk Massachusetts communities that have implemented bystander-administered intranasal naloxone to rates in other high-risk communities that have not, explained Ms. Pierce of the section of general internal medicine at Boston Medical Center.

Bystander-given intranasal naloxone for reversal of opioid overdoses was implemented by the Boston Health Commission in August 2006. Based upon the favorable Boston experience over a 15-month period, the state health department implemented a structured program of overdose education and distribution of intranasal naloxone kits in seven additional sites across the state.

The program is implemented by community-based HIV risk-reduction programs or public health agencies. It entails 1 hour of training in how to recognize signs of overdose, administer intranasal naloxone, and contact emergency medical services. Participants are then given a two-dose kit and encouraged to keep it on their person.

To date nearly 8,000 potential bystanders have been enrolled. These are individuals considered particularly likely to encounter overdoses. They have been enrolled mostly at detox centers, methadone clinics, needle exchange sites, emergency departments, shelters, and drop-in centers. Among the enrollees are 5,351 individuals in treatment for, recovery from, or current active users of illicit drugs and 2,589 nonuser family members and professionals. At enrollment, 78% of people in the active- or past-use group and 47% of the nonusers had previously witnessed an overdose.

At last follow-up, 755 overdoses have been reversed through bystander-administered intranasal naloxone. In two-thirds of cases, the opioid antagonist was administered by a friend, in 14% by a partner or family member, and in 9% by a stranger. A total of 77% of these events took place in private settings. However, the bystander called 911 in only 34% of cases; this low rate is attributed to concern on the part of many bystanders that if they called the authorities, they risked arrest for illicit drug possession.

Naloxone is a Food and Drug Administration–approved drug with no abuse potential. Intranasal naloxone given as a spray via a mucosal atomizer is an off-label use. However, it’s easily administered and has been essentially problem free in the Massachusetts experience, according to Ms. Pierce.

The expectation is that the INPEDE OD study will demonstrate that bystander-administered intranasal naloxone saves lives and prevents trips to the emergency department. If so, the plan is to expand the number of participating sites and seek passage of a state Good Samaritan law providing bystanders with immunity from prosecution, she said.

Ms. Pierce declared she has no relevant financial interests.

DENVER – A novel Massachusetts program of bystander-administered intranasal naloxone shows promise for the treatment of potentially fatal opioid overdoses.

The program was implemented in response to a greater than sixfold increase in the annual number of opioid-related fatal overdoses in Massachusetts from 1990 to 2006. Among 25- to 34-year-olds in Massachusetts, mortality attributable to opioid overdose is greater than that attributable to motor vehicle accidents, Courtney E. Pierce observed at the annual meeting of the American Public Health Association.

This is a national problem fostered by the ready availability of relatively low-cost, high-purity heroin along with the marked growth in opioid prescriptions, some of which are diverted for recreational use as street drugs. That’s why the Centers for Disease Control and Prevention is funding the ongoing 2-year Intranasal Naloxone and Prevention Education’s Effect on Overdose (INPEDE OD) study, The INPEDE OD study is comparing opioid overdose rates, fatal and nonfatal, in those high-risk Massachusetts communities that have implemented bystander-administered intranasal naloxone to rates in other high-risk communities that have not, explained Ms. Pierce of the section of general internal medicine at Boston Medical Center.

Bystander-given intranasal naloxone for reversal of opioid overdoses was implemented by the Boston Health Commission in August 2006. Based upon the favorable Boston experience over a 15-month period, the state health department implemented a structured program of overdose education and distribution of intranasal naloxone kits in seven additional sites across the state.

The program is implemented by community-based HIV risk-reduction programs or public health agencies. It entails 1 hour of training in how to recognize signs of overdose, administer intranasal naloxone, and contact emergency medical services. Participants are then given a two-dose kit and encouraged to keep it on their person.

To date nearly 8,000 potential bystanders have been enrolled. These are individuals considered particularly likely to encounter overdoses. They have been enrolled mostly at detox centers, methadone clinics, needle exchange sites, emergency departments, shelters, and drop-in centers. Among the enrollees are 5,351 individuals in treatment for, recovery from, or current active users of illicit drugs and 2,589 nonuser family members and professionals. At enrollment, 78% of people in the active- or past-use group and 47% of the nonusers had previously witnessed an overdose.

At last follow-up, 755 overdoses have been reversed through bystander-administered intranasal naloxone. In two-thirds of cases, the opioid antagonist was administered by a friend, in 14% by a partner or family member, and in 9% by a stranger. A total of 77% of these events took place in private settings. However, the bystander called 911 in only 34% of cases; this low rate is attributed to concern on the part of many bystanders that if they called the authorities, they risked arrest for illicit drug possession.

Naloxone is a Food and Drug Administration–approved drug with no abuse potential. Intranasal naloxone given as a spray via a mucosal atomizer is an off-label use. However, it’s easily administered and has been essentially problem free in the Massachusetts experience, according to Ms. Pierce.

The expectation is that the INPEDE OD study will demonstrate that bystander-administered intranasal naloxone saves lives and prevents trips to the emergency department. If so, the plan is to expand the number of participating sites and seek passage of a state Good Samaritan law providing bystanders with immunity from prosecution, she said.

Ms. Pierce declared she has no relevant financial interests.

DENVER – The prevalence of drinking and driving has steadily declined since the first National Roadside Survey of Alcohol and Drug Use by Drivers was conducted in 1973.

In the most recent of these surveys, just over 12% of weekend nighttime drivers had a detectable blood alcohol level. In contrast, that figure was 36% in the 1973 survey, dropping to 30% in the 1986 survey and 17% in 1996, Maria Vegega, Ph.D., reported at the annual meeting of the American Public Health Association.

For the most recent survey, conducted in 2007, nearly 10,000 noncommercial drivers were randomly stopped and anonymously tested for alcohol and drugs at 300 locations between the hours of 9:30 a.m. on Friday and 3 a.m. on Sunday. Of daytime drivers, 1% had a detectable blood alcohol level; of nighttime drivers, more than 12% had detectable levels.

Additionally, the 2007 survey represents the first time data have been collected on the prevalence of drug use in a random sample of drivers. Overall, 16.3% of drivers had detectable levels of drugs in their blood or oral fluid. Illegal drugs were detected in 11.3% of drivers, with marijuana being most common. The most commonly detected prescription medications were stimulants, found in 3.3% of drivers, followed by narcotic analgesics in 1.6%, sedatives in 0.8%, and antidepressants in 0.7% of all drivers.

A blood alcohol level above the legal limit was present in 4.1% of drivers with a positive drug result, compared with 1.7% of drug-negative drivers.

An ongoing large case-control study is being conducted to identify which drugs are associated with a higher risk of crashes. Results are anticipated in 2012.

In other findings of the 2007 survey, 2.2% of weekend nighttime drivers were intoxicated as defined by a blood alcohol level of 0.08 g/dL or more; the prevalence rose to 4.8% among late-night drivers tested from 1 a.m. to 3 a.m. In the 1973 survey, 7.5% of all nighttime drivers had a blood alcohol level in this range, a rate that declined to 5.4% in 1986 and 4.3% in 1996, according to Dr. Vegega, chief of the behavioral research division at the National Highway Traffic Safety Administration, which conducts the National Roadside Survey.

In the 2007 survey, the proportion of nighttime drivers with a blood alcohol level of at least 0.08 g/dL varied by age from a high of 3.6% among drivers aged 65 and over to 0.9% in those under age 21. Nighttime motorcycle drivers had a 5.6% prevalence of a blood alcohol level of 0.08 g/dL or more, compared to a 1.3% rate for drivers of sports utility vehicles, 3.3% for those at the helm of pickup trucks, and 2.3% for passenger car drivers.

Dr. Vegega declared having no relevant financial disclosures.

DENVER – The prevalence of drinking and driving has steadily declined since the first National Roadside Survey of Alcohol and Drug Use by Drivers was conducted in 1973.

In the most recent of these surveys, just over 12% of weekend nighttime drivers had a detectable blood alcohol level. In contrast, that figure was 36% in the 1973 survey, dropping to 30% in the 1986 survey and 17% in 1996, Maria Vegega, Ph.D., reported at the annual meeting of the American Public Health Association.

For the most recent survey, conducted in 2007, nearly 10,000 noncommercial drivers were randomly stopped and anonymously tested for alcohol and drugs at 300 locations between the hours of 9:30 a.m. on Friday and 3 a.m. on Sunday. Of daytime drivers, 1% had a detectable blood alcohol level; of nighttime drivers, more than 12% had detectable levels.

Additionally, the 2007 survey represents the first time data have been collected on the prevalence of drug use in a random sample of drivers. Overall, 16.3% of drivers had detectable levels of drugs in their blood or oral fluid. Illegal drugs were detected in 11.3% of drivers, with marijuana being most common. The most commonly detected prescription medications were stimulants, found in 3.3% of drivers, followed by narcotic analgesics in 1.6%, sedatives in 0.8%, and antidepressants in 0.7% of all drivers.

A blood alcohol level above the legal limit was present in 4.1% of drivers with a positive drug result, compared with 1.7% of drug-negative drivers.

An ongoing large case-control study is being conducted to identify which drugs are associated with a higher risk of crashes. Results are anticipated in 2012.

In other findings of the 2007 survey, 2.2% of weekend nighttime drivers were intoxicated as defined by a blood alcohol level of 0.08 g/dL or more; the prevalence rose to 4.8% among late-night drivers tested from 1 a.m. to 3 a.m. In the 1973 survey, 7.5% of all nighttime drivers had a blood alcohol level in this range, a rate that declined to 5.4% in 1986 and 4.3% in 1996, according to Dr. Vegega, chief of the behavioral research division at the National Highway Traffic Safety Administration, which conducts the National Roadside Survey.

In the 2007 survey, the proportion of nighttime drivers with a blood alcohol level of at least 0.08 g/dL varied by age from a high of 3.6% among drivers aged 65 and over to 0.9% in those under age 21. Nighttime motorcycle drivers had a 5.6% prevalence of a blood alcohol level of 0.08 g/dL or more, compared to a 1.3% rate for drivers of sports utility vehicles, 3.3% for those at the helm of pickup trucks, and 2.3% for passenger car drivers.

Dr. Vegega declared having no relevant financial disclosures.

DENVER – The prevalence of drinking and driving has steadily declined since the first National Roadside Survey of Alcohol and Drug Use by Drivers was conducted in 1973.

In the most recent of these surveys, just over 12% of weekend nighttime drivers had a detectable blood alcohol level. In contrast, that figure was 36% in the 1973 survey, dropping to 30% in the 1986 survey and 17% in 1996, Maria Vegega, Ph.D., reported at the annual meeting of the American Public Health Association.

For the most recent survey, conducted in 2007, nearly 10,000 noncommercial drivers were randomly stopped and anonymously tested for alcohol and drugs at 300 locations between the hours of 9:30 a.m. on Friday and 3 a.m. on Sunday. Of daytime drivers, 1% had a detectable blood alcohol level; of nighttime drivers, more than 12% had detectable levels.

Additionally, the 2007 survey represents the first time data have been collected on the prevalence of drug use in a random sample of drivers. Overall, 16.3% of drivers had detectable levels of drugs in their blood or oral fluid. Illegal drugs were detected in 11.3% of drivers, with marijuana being most common. The most commonly detected prescription medications were stimulants, found in 3.3% of drivers, followed by narcotic analgesics in 1.6%, sedatives in 0.8%, and antidepressants in 0.7% of all drivers.

A blood alcohol level above the legal limit was present in 4.1% of drivers with a positive drug result, compared with 1.7% of drug-negative drivers.

An ongoing large case-control study is being conducted to identify which drugs are associated with a higher risk of crashes. Results are anticipated in 2012.

In other findings of the 2007 survey, 2.2% of weekend nighttime drivers were intoxicated as defined by a blood alcohol level of 0.08 g/dL or more; the prevalence rose to 4.8% among late-night drivers tested from 1 a.m. to 3 a.m. In the 1973 survey, 7.5% of all nighttime drivers had a blood alcohol level in this range, a rate that declined to 5.4% in 1986 and 4.3% in 1996, according to Dr. Vegega, chief of the behavioral research division at the National Highway Traffic Safety Administration, which conducts the National Roadside Survey.

In the 2007 survey, the proportion of nighttime drivers with a blood alcohol level of at least 0.08 g/dL varied by age from a high of 3.6% among drivers aged 65 and over to 0.9% in those under age 21. Nighttime motorcycle drivers had a 5.6% prevalence of a blood alcohol level of 0.08 g/dL or more, compared to a 1.3% rate for drivers of sports utility vehicles, 3.3% for those at the helm of pickup trucks, and 2.3% for passenger car drivers.

Dr. Vegega declared having no relevant financial disclosures.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.

GOTHENBURG, SWEDEN - Compliance with topical dermatologic therapies is worse than most physicians realize, according to a new study presented at the annual congress of the European Academy for Dermatology and Venereology.

Through a series of Danish studies utilizing the nation’s comprehensive electronic medical and pharmacy records system, investigators concluded that more than one in three new prescriptions for creams and ointments for dermatologic diseases is never picked up. And for those who actually do fill their prescriptions, treatment adherence just goes downhill from there.

"I would say that even an optimistic estimate would be that only one in five patients truly follows the treatment advice and takes their treatment at home. It's really an alarming figure. The typical result is that the patient comes in complaining, 'It didn't work, doctor,' and now they expect another prescription," Dr. Jørgen Serup said.

"Creams and ointments are truly messy, greasy, cumbersome, and patients can only treat a limited number of lesions on a limited area, and only on certain anatomic sites. These are serious limitations. This is a lot more difficult than just taking a pill," added Dr. Serup, professor of dermatology at Copenhagen University. "Maybe the creams and ointments are really obsolete because they are so difficult to use in clinical practice. Maybe we should be using much more systemic therapy."

He and his colleagues examined all new prescriptions for previously untried medications issued for dermatologic outpatients at Copenhagen University Hospital every 15th day during 2006. Thirty-one percent of the 322 eligible patients exhibited what Dr. Serup termed "primary nonadherence," meaning they never collected their medication. Patients with psoriasis were the biggest offenders; they failed to pick up their medications 44% of the time. This was also the case for 31% of atopic dermatitis patients, 12% being treated for skin infections, and 9% of acne patients.

Thirty-five percent of prescriptions for topical preparations remained behind the pharmacy counter. Prescriptions for systemic agents fared much better; only 14% went unredeemed (J. Am. Acad. Dermatol. 2008;59:27-33).

In another study, the Danish dermatologists visited the homes of 17 first-time dermatologic outpatients who had been given prescriptions for previously untried topical medications. Upon weighing the patients' drug containers, the investigators found only 1 of the 17 patients used the directed dosage. Two patients never picked up their prescriptions, 13 used too little drug, and 1 patient used too much (J. Am. Acad. Dermatol. 2008;59:975-80).

Inadequate application of topical agents is another problem. In a joint study conducted with Swedish dermatologists, the Danish investigators found that highly motivated volunteers applied a fluorescent test cream to only 69% of the skin surface as directed. Areas prone to neglect included the upper breast, axilla and surrounding skin, posterior trunk, legs, and soles of the feet (Br. J. Dermatol. 2007;156:974-8).

Yet another form of treatment noncompliance results from patients’ failure to show up for scheduled appointments. Dr. Serup and coworkers recently reviewed 3,592 patient appointments at the university hospital’s outpatient dermatology clinic and found that 13% of patients didn’t keep their appointments. Patients failed to show for about 10% of all appointments because of forgetfulness or a variety of excuses; this was most common in patients under age 30. The rest of the no-shows were caused by booking mistakes by the clinic staff.

Poor physician-patient communication plays a role in noncompliance as well, as underscored in a study in which Dr. Serup’s colleagues taped and studied 57 dermatologic consultations with 17 dermatology patients, all of whom received new prescriptions for topical agents. At follow-up 2 weeks later, only 41% of patients were familiar with their diagnosis, 71% understood the recommended number of treatment applications per day, and 35% knew the planned duration of treatment. Just 12% of patients understood the proper quantity of the topical agent to be applied; their ignorance on this score was understandable, since dermatologists covered that key issue in only 18% of the recorded clinic visits. Moreover, dermatologists provided a clear explanation of the diagnosis in only 65% of cases (J. Dermatolog. Treat. 2009;20:190-3).

On a more optimistic note, Dr. Serup believes mobile phones and other modern tools can be better utilized to boost compliance among dermatology patients, especially the younger ones, who tend to have the lowest compliance rates. The literature shows that text message reminders and email consultations are effective in this regard, at least within general medicine. A system recently developed in Sweden allows patients to install software on their mobile phone so they can monitor their disease and phone their physician for data transfer and to communicate about therapy. Dr. Serup has utilized this technology to follow the course of treatment in patients with atopic dermatitis.

"It is exactly the language of the [younger generation] to have the information displayed on a mobile phone screen. This can't be used in the elderly, though," he said.

He declared having no relevant financial interests.

GOTHENBURG, SWEDEN - Compliance with topical dermatologic therapies is worse than most physicians realize, according to a new study presented at the annual congress of the European Academy for Dermatology and Venereology.

Through a series of Danish studies utilizing the nation’s comprehensive electronic medical and pharmacy records system, investigators concluded that more than one in three new prescriptions for creams and ointments for dermatologic diseases is never picked up. And for those who actually do fill their prescriptions, treatment adherence just goes downhill from there.

"I would say that even an optimistic estimate would be that only one in five patients truly follows the treatment advice and takes their treatment at home. It's really an alarming figure. The typical result is that the patient comes in complaining, 'It didn't work, doctor,' and now they expect another prescription," Dr. Jørgen Serup said.

"Creams and ointments are truly messy, greasy, cumbersome, and patients can only treat a limited number of lesions on a limited area, and only on certain anatomic sites. These are serious limitations. This is a lot more difficult than just taking a pill," added Dr. Serup, professor of dermatology at Copenhagen University. "Maybe the creams and ointments are really obsolete because they are so difficult to use in clinical practice. Maybe we should be using much more systemic therapy."

He and his colleagues examined all new prescriptions for previously untried medications issued for dermatologic outpatients at Copenhagen University Hospital every 15th day during 2006. Thirty-one percent of the 322 eligible patients exhibited what Dr. Serup termed "primary nonadherence," meaning they never collected their medication. Patients with psoriasis were the biggest offenders; they failed to pick up their medications 44% of the time. This was also the case for 31% of atopic dermatitis patients, 12% being treated for skin infections, and 9% of acne patients.

Thirty-five percent of prescriptions for topical preparations remained behind the pharmacy counter. Prescriptions for systemic agents fared much better; only 14% went unredeemed (J. Am. Acad. Dermatol. 2008;59:27-33).

In another study, the Danish dermatologists visited the homes of 17 first-time dermatologic outpatients who had been given prescriptions for previously untried topical medications. Upon weighing the patients' drug containers, the investigators found only 1 of the 17 patients used the directed dosage. Two patients never picked up their prescriptions, 13 used too little drug, and 1 patient used too much (J. Am. Acad. Dermatol. 2008;59:975-80).

Inadequate application of topical agents is another problem. In a joint study conducted with Swedish dermatologists, the Danish investigators found that highly motivated volunteers applied a fluorescent test cream to only 69% of the skin surface as directed. Areas prone to neglect included the upper breast, axilla and surrounding skin, posterior trunk, legs, and soles of the feet (Br. J. Dermatol. 2007;156:974-8).

Yet another form of treatment noncompliance results from patients’ failure to show up for scheduled appointments. Dr. Serup and coworkers recently reviewed 3,592 patient appointments at the university hospital’s outpatient dermatology clinic and found that 13% of patients didn’t keep their appointments. Patients failed to show for about 10% of all appointments because of forgetfulness or a variety of excuses; this was most common in patients under age 30. The rest of the no-shows were caused by booking mistakes by the clinic staff.

Poor physician-patient communication plays a role in noncompliance as well, as underscored in a study in which Dr. Serup’s colleagues taped and studied 57 dermatologic consultations with 17 dermatology patients, all of whom received new prescriptions for topical agents. At follow-up 2 weeks later, only 41% of patients were familiar with their diagnosis, 71% understood the recommended number of treatment applications per day, and 35% knew the planned duration of treatment. Just 12% of patients understood the proper quantity of the topical agent to be applied; their ignorance on this score was understandable, since dermatologists covered that key issue in only 18% of the recorded clinic visits. Moreover, dermatologists provided a clear explanation of the diagnosis in only 65% of cases (J. Dermatolog. Treat. 2009;20:190-3).

On a more optimistic note, Dr. Serup believes mobile phones and other modern tools can be better utilized to boost compliance among dermatology patients, especially the younger ones, who tend to have the lowest compliance rates. The literature shows that text message reminders and email consultations are effective in this regard, at least within general medicine. A system recently developed in Sweden allows patients to install software on their mobile phone so they can monitor their disease and phone their physician for data transfer and to communicate about therapy. Dr. Serup has utilized this technology to follow the course of treatment in patients with atopic dermatitis.

"It is exactly the language of the [younger generation] to have the information displayed on a mobile phone screen. This can't be used in the elderly, though," he said.

He declared having no relevant financial interests.

GOTHENBURG, SWEDEN - Compliance with topical dermatologic therapies is worse than most physicians realize, according to a new study presented at the annual congress of the European Academy for Dermatology and Venereology.

Through a series of Danish studies utilizing the nation’s comprehensive electronic medical and pharmacy records system, investigators concluded that more than one in three new prescriptions for creams and ointments for dermatologic diseases is never picked up. And for those who actually do fill their prescriptions, treatment adherence just goes downhill from there.

"I would say that even an optimistic estimate would be that only one in five patients truly follows the treatment advice and takes their treatment at home. It's really an alarming figure. The typical result is that the patient comes in complaining, 'It didn't work, doctor,' and now they expect another prescription," Dr. Jørgen Serup said.

"Creams and ointments are truly messy, greasy, cumbersome, and patients can only treat a limited number of lesions on a limited area, and only on certain anatomic sites. These are serious limitations. This is a lot more difficult than just taking a pill," added Dr. Serup, professor of dermatology at Copenhagen University. "Maybe the creams and ointments are really obsolete because they are so difficult to use in clinical practice. Maybe we should be using much more systemic therapy."

He and his colleagues examined all new prescriptions for previously untried medications issued for dermatologic outpatients at Copenhagen University Hospital every 15th day during 2006. Thirty-one percent of the 322 eligible patients exhibited what Dr. Serup termed "primary nonadherence," meaning they never collected their medication. Patients with psoriasis were the biggest offenders; they failed to pick up their medications 44% of the time. This was also the case for 31% of atopic dermatitis patients, 12% being treated for skin infections, and 9% of acne patients.

Thirty-five percent of prescriptions for topical preparations remained behind the pharmacy counter. Prescriptions for systemic agents fared much better; only 14% went unredeemed (J. Am. Acad. Dermatol. 2008;59:27-33).

In another study, the Danish dermatologists visited the homes of 17 first-time dermatologic outpatients who had been given prescriptions for previously untried topical medications. Upon weighing the patients' drug containers, the investigators found only 1 of the 17 patients used the directed dosage. Two patients never picked up their prescriptions, 13 used too little drug, and 1 patient used too much (J. Am. Acad. Dermatol. 2008;59:975-80).

Inadequate application of topical agents is another problem. In a joint study conducted with Swedish dermatologists, the Danish investigators found that highly motivated volunteers applied a fluorescent test cream to only 69% of the skin surface as directed. Areas prone to neglect included the upper breast, axilla and surrounding skin, posterior trunk, legs, and soles of the feet (Br. J. Dermatol. 2007;156:974-8).

Yet another form of treatment noncompliance results from patients’ failure to show up for scheduled appointments. Dr. Serup and coworkers recently reviewed 3,592 patient appointments at the university hospital’s outpatient dermatology clinic and found that 13% of patients didn’t keep their appointments. Patients failed to show for about 10% of all appointments because of forgetfulness or a variety of excuses; this was most common in patients under age 30. The rest of the no-shows were caused by booking mistakes by the clinic staff.

Poor physician-patient communication plays a role in noncompliance as well, as underscored in a study in which Dr. Serup’s colleagues taped and studied 57 dermatologic consultations with 17 dermatology patients, all of whom received new prescriptions for topical agents. At follow-up 2 weeks later, only 41% of patients were familiar with their diagnosis, 71% understood the recommended number of treatment applications per day, and 35% knew the planned duration of treatment. Just 12% of patients understood the proper quantity of the topical agent to be applied; their ignorance on this score was understandable, since dermatologists covered that key issue in only 18% of the recorded clinic visits. Moreover, dermatologists provided a clear explanation of the diagnosis in only 65% of cases (J. Dermatolog. Treat. 2009;20:190-3).

On a more optimistic note, Dr. Serup believes mobile phones and other modern tools can be better utilized to boost compliance among dermatology patients, especially the younger ones, who tend to have the lowest compliance rates. The literature shows that text message reminders and email consultations are effective in this regard, at least within general medicine. A system recently developed in Sweden allows patients to install software on their mobile phone so they can monitor their disease and phone their physician for data transfer and to communicate about therapy. Dr. Serup has utilized this technology to follow the course of treatment in patients with atopic dermatitis.

"It is exactly the language of the [younger generation] to have the information displayed on a mobile phone screen. This can't be used in the elderly, though," he said.

He declared having no relevant financial interests.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.

GOTHENBURG, SWEDEN – For psoriasis patients, all tumor necrosis factor inhibitors are associated with roughly the same risks for serious infection, according to a meta-analysis of data from major randomized clinical trials and their long-term, open-label extensions.

Regardless of whether etanercept, infliximab, or adalimumab was the prescribed agent, the serious infection risk for psoriasis patients was in the range of 1.0-1.5 cases per 100 patient-years of therapy. Thus, 1 in every 10 patients on any given TNF-inhibitor could expect to have about one serious skin infection every 10 years, Dr. Richard Langley said at a satellite symposium held during the annual congress of the European Academy of Dermatology and Venereology.

"Serious" infections in this context may or may not be a big deal. A serious infection, under the definition employed in the clinical trials, is one requiring intravenous antibiotics or hospitalization. The number-needed-to-harm – that is, the number of psoriasis patients who would need to be treated with an anti-TNF biologic rather than placebo for 1 year in order to cause one additional serious infection – is at least two orders of magnitude larger than the number-needed-to-treat in order to achieve a PASI 75 treatment response. That’s an extremely favorable risk-benefit ratio, said Dr. Langley, professor of medicine and director of research in the division of dermatology at Dalhousie University, Halifax, Nova Scotia.

His recently published meta-analysis (Br. J. Dermatol. 2010 Apr 14 [Epub ahead of print]) showed that the number-needed-to-treat was 1.4 patients with infliximab dosed at 5 mg/kg, 1.6 for adalimumab at 40 mg every 2 weeks, 2.3 for etanercept at 50 mg twice weekly, and 3.2 for etanercept at 50 mg once weekly or 25 mg twice weekly, he reported at the satellite symposium sponsored by Abbott.

Serious infections warrant a temporary interruption of anti-TNF therapy. But so do clinically important infections that don’t rise to the threshold of "serious," he said, for example, a case of cellulitis being treated on an outpatient basis with oral antibiotics. Continuing anti-TNF therapy in such a patient increases the risk of a more complicated infection.

"I would submit to you that it’s better to be conservative in situations like this and withhold therapy," he said.

All of the TNF inhibitors – indeed, probably all biologic therapies – increase the risk of upper respiratory infections, bronchitis, and nasopharyngitis. These are minor infections, and it’s generally appropriate to push ahead with therapy, as was routine practice in the clinical trials, Dr. Langley noted.

However, participants in clinical trials are a carefully selected subgroup. They often are quite dissimilar in key ways to patients encountered in daily clinical practice. Registry data better reflect real-world patients. And while registries of psoriasis patients on biologic therapies are now up and running, the follow-up isn’t yet sufficiently long for data analysis.

Dermatologists seeking to gain a fuller understanding of the safety issues surrounding the TNF antagonists can turn to the rheumatology experience with biologics. British Society for Rheumatology Biologics Registry data show an incidence of skin and soft tissue infections in rheumatoid arthritis patients that is 3.0 cases per 1,000 patient-years of treatment with methotrexate or other traditional disease-modifying anti-rheumatic drugs (DMARDs) and 12.0 per 1,000 patient-years in those on TNF inhibitors, for an adjusted 4.3-fold increased relative risk accompanying the newer agents (Arthritis Rheum. 2006 54:2,368-76).

But it’s important to remember that psoriasis patients differ in important ways from those with rheumatoid arthritis, Dr. Langley noted. The arthritis patients are much more likely, for example, to be on concomitant treatment with systemic corticosteroids, and perhaps to have intrinsic disease-related qualities predisposing to serious infections.

This point was effectively underscored in a formal analysis of serious adverse events in clinical trials of adalimumab across all indications (Ann. Rheum. Dis. 2009;68:1,863-9). The incidence of serious infections per 100 patient-years of exposure to adalimumab was 4.7 for rheumatoid arthritis patients, compared with 1.3 in those being treated for psoriasis.

Dr. Langley disclosed serving as a speaker for Abbott and having financial relationships with numerous other pharmaceutical companies that manufacture psoriasis therapies.