Pediatrics

Photo by Rhoda Baer

New research suggests race, clinical trial participation, and treatment duration may influence the risk of relapse in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL).

The study showed that AYAs with ALL were significantly more likely to relapse than pediatric ALL patients.

Among AYAs, the risk of on-therapy relapse was higher for non-white patients and those who did not participate in clinical trials. The risk of relapse after therapy was higher for AYAs with a shorter treatment duration.

Julie A. Wolfson, MD, of University of Alabama at Birmingham, and her colleagues reported these findings in Cancer Epidemiology, Biomarkers & Prevention.

The researchers conducted this study to investigate why AYAs with ALL have not experienced the same improvement in survival rates as pediatric patients with ALL.

“Patients diagnosed between the ages of 15 and 39 simply have not seen the same improvement as those in other age groups,” Dr. Wolfson said. “In this study, we examined factors related to health care delivery and treatment to increase our understanding of why they experience poorer outcomes.”

The researchers retrospectively studied ALL patients diagnosed between ages 1 and 39 and treated at a single center between 1990 and 2010.

Ninety-one patients were children (ages 1 to 14), and 93 were AYAs (ages 15 to 39).

The researchers assessed variables including demographics, insurance status, participation in clinical trials, duration of treatment, and whether the patients had been treated with pediatric-inspired or adult-inspired regimens. Using Kaplan-Meier survival analysis, the researchers calculated the risk of relapse.

Results

As previous research indicated, children with ALL had superior relapse-free survival compared to AYAs.

The 5-year relapse-free survival rate was 74% in children, 29% in younger AYAs (ages 15 to 21), and 32% in older AYAs (ages 22-39). The difference between children and AYAs was statistically significant (P<0.0001), but the difference between younger and older AYAs was not (P=0.6).

Forty-eight percent of AYAs relapsed while on therapy, compared with 17% of children (P<0.001).

In a multivariable analysis adjusted for clinical prognosticators, health care delivery, and treatment, the risk of on-therapy relapse was more than 10 times higher among AYAs than children (hazard ratio [HR], 10.5; P=0.004).

Among AYAs, the strongest predictors of on-therapy relapse were race and enrollment in clinical trials.

Non-white patients were more than twice as likely to relapse as white patients (HR, 2.2; P=0.05), and patients who were not enrolled in clinical trials were more than twice as likely to relapse as trial participants (HR, 2.6, P=0.04).

Dr. Wolfson said this finding adds to evidence suggesting AYA patients should be encouraged to participate in clinical trials.

“It is possible that patients sometimes benefit from being enrolled on a clinical trial not only because the therapy itself is providing a benefit, but also because it is a protocolized, regulated approach that requires patients to stay on course and not take breaks,” she said.

After the completion of therapy, 47% of AYAs suffered a relapse, compared to 13% of children (P<0.0001).

In a multivariable analysis, the risk of relapse after therapy was more than seven times higher among AYAs than children (HR, 7.7; P<0.001).

Among AYAs who relapsed after therapy, the most significant factor associated with relapse was the duration of treatment.

For each additional month of consolidation therapy, there was a 20% lower risk of relapse (HR, 0.8; P=0.03). And for each additional month of maintenance, there was a 30% lower risk of relapse (HR, 0.7; P<0.001).

Dr. Wolfson noted that a range of factors may affect the duration of treatment. For example, the AYA population is more likely to be uninsured or underinsured, which can make them more likely to stop treatment or miss appointments.

Finally, Dr. Wolfson acknowledged that this study had limitations, primarily its single-institution approach and its limited sample size.

This study was funded by the National Institutes of Health, the St. Baldrick’s Scholar Career Development Award, and the Concern Foundation. The authors declared no conflicts of interest.

Photo by Rhoda Baer

New research suggests race, clinical trial participation, and treatment duration may influence the risk of relapse in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL).

The study showed that AYAs with ALL were significantly more likely to relapse than pediatric ALL patients.

Among AYAs, the risk of on-therapy relapse was higher for non-white patients and those who did not participate in clinical trials. The risk of relapse after therapy was higher for AYAs with a shorter treatment duration.

Julie A. Wolfson, MD, of University of Alabama at Birmingham, and her colleagues reported these findings in Cancer Epidemiology, Biomarkers & Prevention.

The researchers conducted this study to investigate why AYAs with ALL have not experienced the same improvement in survival rates as pediatric patients with ALL.

“Patients diagnosed between the ages of 15 and 39 simply have not seen the same improvement as those in other age groups,” Dr. Wolfson said. “In this study, we examined factors related to health care delivery and treatment to increase our understanding of why they experience poorer outcomes.”

The researchers retrospectively studied ALL patients diagnosed between ages 1 and 39 and treated at a single center between 1990 and 2010.

Ninety-one patients were children (ages 1 to 14), and 93 were AYAs (ages 15 to 39).

The researchers assessed variables including demographics, insurance status, participation in clinical trials, duration of treatment, and whether the patients had been treated with pediatric-inspired or adult-inspired regimens. Using Kaplan-Meier survival analysis, the researchers calculated the risk of relapse.

Results

As previous research indicated, children with ALL had superior relapse-free survival compared to AYAs.

The 5-year relapse-free survival rate was 74% in children, 29% in younger AYAs (ages 15 to 21), and 32% in older AYAs (ages 22-39). The difference between children and AYAs was statistically significant (P<0.0001), but the difference between younger and older AYAs was not (P=0.6).

Forty-eight percent of AYAs relapsed while on therapy, compared with 17% of children (P<0.001).

In a multivariable analysis adjusted for clinical prognosticators, health care delivery, and treatment, the risk of on-therapy relapse was more than 10 times higher among AYAs than children (hazard ratio [HR], 10.5; P=0.004).

Among AYAs, the strongest predictors of on-therapy relapse were race and enrollment in clinical trials.

Non-white patients were more than twice as likely to relapse as white patients (HR, 2.2; P=0.05), and patients who were not enrolled in clinical trials were more than twice as likely to relapse as trial participants (HR, 2.6, P=0.04).

Dr. Wolfson said this finding adds to evidence suggesting AYA patients should be encouraged to participate in clinical trials.

“It is possible that patients sometimes benefit from being enrolled on a clinical trial not only because the therapy itself is providing a benefit, but also because it is a protocolized, regulated approach that requires patients to stay on course and not take breaks,” she said.

After the completion of therapy, 47% of AYAs suffered a relapse, compared to 13% of children (P<0.0001).

In a multivariable analysis, the risk of relapse after therapy was more than seven times higher among AYAs than children (HR, 7.7; P<0.001).

Among AYAs who relapsed after therapy, the most significant factor associated with relapse was the duration of treatment.

For each additional month of consolidation therapy, there was a 20% lower risk of relapse (HR, 0.8; P=0.03). And for each additional month of maintenance, there was a 30% lower risk of relapse (HR, 0.7; P<0.001).

Dr. Wolfson noted that a range of factors may affect the duration of treatment. For example, the AYA population is more likely to be uninsured or underinsured, which can make them more likely to stop treatment or miss appointments.

Finally, Dr. Wolfson acknowledged that this study had limitations, primarily its single-institution approach and its limited sample size.

This study was funded by the National Institutes of Health, the St. Baldrick’s Scholar Career Development Award, and the Concern Foundation. The authors declared no conflicts of interest.

Photo by Rhoda Baer

New research suggests race, clinical trial participation, and treatment duration may influence the risk of relapse in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL).

The study showed that AYAs with ALL were significantly more likely to relapse than pediatric ALL patients.

Among AYAs, the risk of on-therapy relapse was higher for non-white patients and those who did not participate in clinical trials. The risk of relapse after therapy was higher for AYAs with a shorter treatment duration.

Julie A. Wolfson, MD, of University of Alabama at Birmingham, and her colleagues reported these findings in Cancer Epidemiology, Biomarkers & Prevention.

The researchers conducted this study to investigate why AYAs with ALL have not experienced the same improvement in survival rates as pediatric patients with ALL.

“Patients diagnosed between the ages of 15 and 39 simply have not seen the same improvement as those in other age groups,” Dr. Wolfson said. “In this study, we examined factors related to health care delivery and treatment to increase our understanding of why they experience poorer outcomes.”

The researchers retrospectively studied ALL patients diagnosed between ages 1 and 39 and treated at a single center between 1990 and 2010.

Ninety-one patients were children (ages 1 to 14), and 93 were AYAs (ages 15 to 39).

The researchers assessed variables including demographics, insurance status, participation in clinical trials, duration of treatment, and whether the patients had been treated with pediatric-inspired or adult-inspired regimens. Using Kaplan-Meier survival analysis, the researchers calculated the risk of relapse.

Results

As previous research indicated, children with ALL had superior relapse-free survival compared to AYAs.

The 5-year relapse-free survival rate was 74% in children, 29% in younger AYAs (ages 15 to 21), and 32% in older AYAs (ages 22-39). The difference between children and AYAs was statistically significant (P<0.0001), but the difference between younger and older AYAs was not (P=0.6).

Forty-eight percent of AYAs relapsed while on therapy, compared with 17% of children (P<0.001).

In a multivariable analysis adjusted for clinical prognosticators, health care delivery, and treatment, the risk of on-therapy relapse was more than 10 times higher among AYAs than children (hazard ratio [HR], 10.5; P=0.004).

Among AYAs, the strongest predictors of on-therapy relapse were race and enrollment in clinical trials.

Non-white patients were more than twice as likely to relapse as white patients (HR, 2.2; P=0.05), and patients who were not enrolled in clinical trials were more than twice as likely to relapse as trial participants (HR, 2.6, P=0.04).

Dr. Wolfson said this finding adds to evidence suggesting AYA patients should be encouraged to participate in clinical trials.

“It is possible that patients sometimes benefit from being enrolled on a clinical trial not only because the therapy itself is providing a benefit, but also because it is a protocolized, regulated approach that requires patients to stay on course and not take breaks,” she said.

After the completion of therapy, 47% of AYAs suffered a relapse, compared to 13% of children (P<0.0001).

In a multivariable analysis, the risk of relapse after therapy was more than seven times higher among AYAs than children (HR, 7.7; P<0.001).

Among AYAs who relapsed after therapy, the most significant factor associated with relapse was the duration of treatment.

For each additional month of consolidation therapy, there was a 20% lower risk of relapse (HR, 0.8; P=0.03). And for each additional month of maintenance, there was a 30% lower risk of relapse (HR, 0.7; P<0.001).

Dr. Wolfson noted that a range of factors may affect the duration of treatment. For example, the AYA population is more likely to be uninsured or underinsured, which can make them more likely to stop treatment or miss appointments.

Finally, Dr. Wolfson acknowledged that this study had limitations, primarily its single-institution approach and its limited sample size.

This study was funded by the National Institutes of Health, the St. Baldrick’s Scholar Career Development Award, and the Concern Foundation. The authors declared no conflicts of interest.

The lesion on this 12-year-old girl’s trunk has been present since birth, growing slowly as she has. Recently, an abrasion sustained during a basketball game caused the lesion to become swollen and tender. It has since returned to its original size and nontender state, but the change in appearance raised enough concern to prompt dermatologic consultation.

The child is otherwise healthy and reports having had very few sunburns, tanning easily (though seldom).

EXAMINATION
The lesion—an oval, nevoid, hair-bearing, uniformly brown plaque with a mammilated surface—is located on the right lower anterior abdominal wall and measures just short of 3 cm x 2 cm. It bears no sign of the recent trauma. The margins are clearly defined, and the lesion is nontender on palpation. No increased warmth is detected.

Overall, the patient’s type III skin has little, if any, evidence of excessive sun exposure.

What is the diagnosis?

DISCUSSION
Congenital melanocytic nevi (CMNs) affect about 1% of newborns, appearing within months after birth. There is no unanimity in opinion regarding their origin, although they appear to be hereditary in some cases.

About 50% of CMNs occur on the trunk and 15% on the head or neck; the rest are scattered about on the extremities. The distinctive morphologic appearance of the lesion helps to distinguish it from other items in the differential, such as warts or cancer.

Only rarely do CMNs raise concern for malignant potential. (Trauma cannot cause a benign lesion to undergo malignant transformation.) So-called “giant” CMNs (> 20 cm) appear to be associated with the greatest risk, though the incidence of melanoma in children younger than 9 is only about 0.7 cases per million. Of particular concern are “bathing trunk” CMNs, which occasionally cover more than half of the body; affected patients need special attention from pediatric dermatologists who have the appropriate experience.

Neither “small” (< 2 cm) nor “medium” CMNs (> 2 cm, < 20 cm) are particularly worrisome in terms of malignancy. But depending on the location and original size, CMNs can become the object of unwanted attention or ridicule from peers—a little 1-cm lesion on an infant’s neck can grow four to six times its original size by puberty. And at that point, excision becomes much more problematic due to the likelihood of scarring.

Therefore, many experts advise excising some lesions early on, while the lesion and resulting scar are small—and before the child has a chance to develop any anxiety over it. If not excised, CMNs simply need to be watched for change (size, uniformity of color, and border).

TAKE-HOME LEARNING POINTS

• Congenital melanocytic nevi (CMNs) < 20 cm in diameter are generally quite safe but can grow much larger—often becoming a source of ridicule.
• Depending on the size, location, and appearance of the lesion, excision is justifiable before it has a chance to grow and become problematic.
• Children younger than 10 almost never develop melanoma (the rate is 0.7 cases per million)—and even when they do, it is almost never related to malignant transformation of a CMN.
• Trauma cannot cause a benign lesion to undergo malignant transformation.

The lesion on this 12-year-old girl’s trunk has been present since birth, growing slowly as she has. Recently, an abrasion sustained during a basketball game caused the lesion to become swollen and tender. It has since returned to its original size and nontender state, but the change in appearance raised enough concern to prompt dermatologic consultation.

The child is otherwise healthy and reports having had very few sunburns, tanning easily (though seldom).

EXAMINATION
The lesion—an oval, nevoid, hair-bearing, uniformly brown plaque with a mammilated surface—is located on the right lower anterior abdominal wall and measures just short of 3 cm x 2 cm. It bears no sign of the recent trauma. The margins are clearly defined, and the lesion is nontender on palpation. No increased warmth is detected.

Overall, the patient’s type III skin has little, if any, evidence of excessive sun exposure.

What is the diagnosis?

DISCUSSION
Congenital melanocytic nevi (CMNs) affect about 1% of newborns, appearing within months after birth. There is no unanimity in opinion regarding their origin, although they appear to be hereditary in some cases.

About 50% of CMNs occur on the trunk and 15% on the head or neck; the rest are scattered about on the extremities. The distinctive morphologic appearance of the lesion helps to distinguish it from other items in the differential, such as warts or cancer.

Only rarely do CMNs raise concern for malignant potential. (Trauma cannot cause a benign lesion to undergo malignant transformation.) So-called “giant” CMNs (> 20 cm) appear to be associated with the greatest risk, though the incidence of melanoma in children younger than 9 is only about 0.7 cases per million. Of particular concern are “bathing trunk” CMNs, which occasionally cover more than half of the body; affected patients need special attention from pediatric dermatologists who have the appropriate experience.

Neither “small” (< 2 cm) nor “medium” CMNs (> 2 cm, < 20 cm) are particularly worrisome in terms of malignancy. But depending on the location and original size, CMNs can become the object of unwanted attention or ridicule from peers—a little 1-cm lesion on an infant’s neck can grow four to six times its original size by puberty. And at that point, excision becomes much more problematic due to the likelihood of scarring.

Therefore, many experts advise excising some lesions early on, while the lesion and resulting scar are small—and before the child has a chance to develop any anxiety over it. If not excised, CMNs simply need to be watched for change (size, uniformity of color, and border).

TAKE-HOME LEARNING POINTS

• Congenital melanocytic nevi (CMNs) < 20 cm in diameter are generally quite safe but can grow much larger—often becoming a source of ridicule.
• Depending on the size, location, and appearance of the lesion, excision is justifiable before it has a chance to grow and become problematic.
• Children younger than 10 almost never develop melanoma (the rate is 0.7 cases per million)—and even when they do, it is almost never related to malignant transformation of a CMN.
• Trauma cannot cause a benign lesion to undergo malignant transformation.

The lesion on this 12-year-old girl’s trunk has been present since birth, growing slowly as she has. Recently, an abrasion sustained during a basketball game caused the lesion to become swollen and tender. It has since returned to its original size and nontender state, but the change in appearance raised enough concern to prompt dermatologic consultation.

The child is otherwise healthy and reports having had very few sunburns, tanning easily (though seldom).

EXAMINATION
The lesion—an oval, nevoid, hair-bearing, uniformly brown plaque with a mammilated surface—is located on the right lower anterior abdominal wall and measures just short of 3 cm x 2 cm. It bears no sign of the recent trauma. The margins are clearly defined, and the lesion is nontender on palpation. No increased warmth is detected.

Overall, the patient’s type III skin has little, if any, evidence of excessive sun exposure.

What is the diagnosis?

DISCUSSION
Congenital melanocytic nevi (CMNs) affect about 1% of newborns, appearing within months after birth. There is no unanimity in opinion regarding their origin, although they appear to be hereditary in some cases.

About 50% of CMNs occur on the trunk and 15% on the head or neck; the rest are scattered about on the extremities. The distinctive morphologic appearance of the lesion helps to distinguish it from other items in the differential, such as warts or cancer.

Only rarely do CMNs raise concern for malignant potential. (Trauma cannot cause a benign lesion to undergo malignant transformation.) So-called “giant” CMNs (> 20 cm) appear to be associated with the greatest risk, though the incidence of melanoma in children younger than 9 is only about 0.7 cases per million. Of particular concern are “bathing trunk” CMNs, which occasionally cover more than half of the body; affected patients need special attention from pediatric dermatologists who have the appropriate experience.

Neither “small” (< 2 cm) nor “medium” CMNs (> 2 cm, < 20 cm) are particularly worrisome in terms of malignancy. But depending on the location and original size, CMNs can become the object of unwanted attention or ridicule from peers—a little 1-cm lesion on an infant’s neck can grow four to six times its original size by puberty. And at that point, excision becomes much more problematic due to the likelihood of scarring.

Therefore, many experts advise excising some lesions early on, while the lesion and resulting scar are small—and before the child has a chance to develop any anxiety over it. If not excised, CMNs simply need to be watched for change (size, uniformity of color, and border).

TAKE-HOME LEARNING POINTS

• Congenital melanocytic nevi (CMNs) < 20 cm in diameter are generally quite safe but can grow much larger—often becoming a source of ridicule.
• Depending on the size, location, and appearance of the lesion, excision is justifiable before it has a chance to grow and become problematic.
• Children younger than 10 almost never develop melanoma (the rate is 0.7 cases per million)—and even when they do, it is almost never related to malignant transformation of a CMN.
• Trauma cannot cause a benign lesion to undergo malignant transformation.

Lengths of stay in the hospital and in the neonatal ICU (NICU) for infants with neonatal abstinence syndrome (NAS) were significantly shorter with methadone treatment, compared with morphine treatment, according to a study published in the Journal of Pediatrics.

Metin Kiyak/Thinkstock

Veeral N. Tolia, MD, of Baylor University in Dallas, and his associates, gathered data from NICUs participating in the Clinical Data Warehouse and identified 7,667 singleton infants with no congenital abnormalities treated for NAS with either methadone (15%) or morphine (85%) in the first 7 days of life during 2011-2015.

The median hospital length of stay (LOS) was 18 days (interquartile range, 11-30 days) for infants treated with methadone and 23 days (IQR, 16-33 days) for those treated with morphine (P less than .001). The methadone-treated infants also had a shorter median LOS in the NICU than did the morphine-treated infants: 17 days (IQR, 10-29 days) versus 21 days (IQR, 14-36 days; P less than .001). In multivariable analysis, methadone treatment still was associated with a significantly shorter LOS in both cases. The methadone-treated infants also were significantly less likely to require two medications or three or more medications, compared with the morphine treated infants.

Although there was only a modest difference in LOS, Dr. Tolia and associates consider their findings relevant to clinical practice and are important given that “NAS incidence continues to rise and accounts for a substantial portion of health care utilization, including a fourfold increase in the proportion of neonatal hospital costs of all births covered by Medicaid.”

One of the strengths of this study is the size of its cohort; among its weaknesses is that the Clinical Data Warehouse does not include information on symptom severity, indication for starting therapy, or weaning practices.

The researchers declared no conflicts of interest.

cpalmer@mdedge.com

SOURCE: Tolia VN et al. J Pediatr. 2018 Sep. doi: 10.1016/j.jpeds.2018.07.061.

Lengths of stay in the hospital and in the neonatal ICU (NICU) for infants with neonatal abstinence syndrome (NAS) were significantly shorter with methadone treatment, compared with morphine treatment, according to a study published in the Journal of Pediatrics.

Metin Kiyak/Thinkstock

Veeral N. Tolia, MD, of Baylor University in Dallas, and his associates, gathered data from NICUs participating in the Clinical Data Warehouse and identified 7,667 singleton infants with no congenital abnormalities treated for NAS with either methadone (15%) or morphine (85%) in the first 7 days of life during 2011-2015.

The median hospital length of stay (LOS) was 18 days (interquartile range, 11-30 days) for infants treated with methadone and 23 days (IQR, 16-33 days) for those treated with morphine (P less than .001). The methadone-treated infants also had a shorter median LOS in the NICU than did the morphine-treated infants: 17 days (IQR, 10-29 days) versus 21 days (IQR, 14-36 days; P less than .001). In multivariable analysis, methadone treatment still was associated with a significantly shorter LOS in both cases. The methadone-treated infants also were significantly less likely to require two medications or three or more medications, compared with the morphine treated infants.

Although there was only a modest difference in LOS, Dr. Tolia and associates consider their findings relevant to clinical practice and are important given that “NAS incidence continues to rise and accounts for a substantial portion of health care utilization, including a fourfold increase in the proportion of neonatal hospital costs of all births covered by Medicaid.”

One of the strengths of this study is the size of its cohort; among its weaknesses is that the Clinical Data Warehouse does not include information on symptom severity, indication for starting therapy, or weaning practices.

The researchers declared no conflicts of interest.

cpalmer@mdedge.com

SOURCE: Tolia VN et al. J Pediatr. 2018 Sep. doi: 10.1016/j.jpeds.2018.07.061.

Lengths of stay in the hospital and in the neonatal ICU (NICU) for infants with neonatal abstinence syndrome (NAS) were significantly shorter with methadone treatment, compared with morphine treatment, according to a study published in the Journal of Pediatrics.

Metin Kiyak/Thinkstock

Veeral N. Tolia, MD, of Baylor University in Dallas, and his associates, gathered data from NICUs participating in the Clinical Data Warehouse and identified 7,667 singleton infants with no congenital abnormalities treated for NAS with either methadone (15%) or morphine (85%) in the first 7 days of life during 2011-2015.

The median hospital length of stay (LOS) was 18 days (interquartile range, 11-30 days) for infants treated with methadone and 23 days (IQR, 16-33 days) for those treated with morphine (P less than .001). The methadone-treated infants also had a shorter median LOS in the NICU than did the morphine-treated infants: 17 days (IQR, 10-29 days) versus 21 days (IQR, 14-36 days; P less than .001). In multivariable analysis, methadone treatment still was associated with a significantly shorter LOS in both cases. The methadone-treated infants also were significantly less likely to require two medications or three or more medications, compared with the morphine treated infants.

Although there was only a modest difference in LOS, Dr. Tolia and associates consider their findings relevant to clinical practice and are important given that “NAS incidence continues to rise and accounts for a substantial portion of health care utilization, including a fourfold increase in the proportion of neonatal hospital costs of all births covered by Medicaid.”

One of the strengths of this study is the size of its cohort; among its weaknesses is that the Clinical Data Warehouse does not include information on symptom severity, indication for starting therapy, or weaning practices.

The researchers declared no conflicts of interest.

cpalmer@mdedge.com

SOURCE: Tolia VN et al. J Pediatr. 2018 Sep. doi: 10.1016/j.jpeds.2018.07.061.

PARIS – Dupilumab scorched its way through a landmark pivotal phase 3 clinical trial in adolescents with moderate to severe atopic dermatitis (AD), achieving unprecedented clinically meaningful improvements in signs and symptoms of the disease along with important quality of life benefits, Eric L. Simpson, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDEdge News

Indeed, dupilumab (Dupixent), a fully human monoclonal antibody that inhibits interleukins-4 and -13, demonstrated safety and efficacy in adolescent patients akin to that previously shown in adults with moderate to severe AD in phase 3 trials that earned the biologic U.S. and European regulatory approval in the adult population, noted Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.

This positive phase 3 study represents a major development in pediatric dermatology because of the pressing unmet need for better treatments for teens with moderate to severe AD whose disease can’t be controlled with topical therapies. The adolescent years are, after all, a critical period in growth and development, and a debilitating, uncontrolled disease can reshape that experience in unwelcome ways.

“Atopic dermatitis profoundly affects quality of life in adolescents and their family: The itching affects mood and sleep, these patients commonly have anxiety and depression, and the chronic and relapsing nature of the disease adversely affects the family,” the dermatologist observed.

Currently, no systemic agent is approved for pediatric patients with AD because evidence demonstrating a favorable benefit-to-risk profile has been lacking. The dupilumab study was the first-ever phase 3 trial of a biologic in such a population.

The phase 3 adolescent trial was a 16-week, randomized, double-blind, multicenter, placebo-controlled study of 251 patients aged 12-17 years with moderate to severe AD, which could not be adequately controlled with topical therapies. Participants averaged 14 years of age, with a 12-year history of AD. “These patients had the disease basically their whole life,” Dr. Simpson noted.

They were more severely affected than participants in the adult clinical trials, with mean Eczema Area And Severity Index (EASI) scores in the mid-30s and an average 56% involved body surface area. The adolescent AD patients had a heavy burden of comorbid allergic type 2 immune comorbidity: Fully 92% of them had documented asthma, food allergy, allergic rhinitis, and/or some other form of allergic comorbidity. The majority of the teens were categorized as having severe AD, whereas most participants in the adult phase 3 trials of dupilumab had moderate disease. That distinction becomes relevant in comparing the trial results.

Participants were randomized to once-monthly subcutaneous injections of dupilumab at 300 mg, following a 600-mg loading dose, or to an injection of 200 mg or 300 mg every 2 weeks with an initial dose of 400 mg or 600 mg based upon a body weight cutoff of 60 kg, or to biweekly placebo injections.

The coprimary endpoints were the proportion of patients who achieved an EASI 75 response at week 16 and achievement of an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear, on a 5-point scale at week 16.

This trial introduced an important new design feature that physicians can expect to see more of in the future: regulatory agencies now want to see the effects of monotherapy in pivotal studies in AD. Previously, participants in AD studies of systemic agents could also utilize topical steroids as needed. No longer. In the adolescent dupilumab study, resort to rescue topical steroids led to exclusion from inclusion in the primary outcome results. Not surprisingly, this lack of access to rescue medication resulted in a 60% dropout rate by 16 weeks in placebo-treated controls, a 30% dropout rate in teens on dupilumab every 4 weeks, and a 20% dropout rate with biweekly dupilumab.

The EASI 75 rate at week 16 was 8.2% with placebo, 38.1% with monthly dupilumab, and 41.5% with biweekly dosing. The other coprimary endpoint – an IGA of 0 or 1 at 16 weeks – was achieved in 2.4% of controls, 17.9% with dupilumab at 300 mg every 4 weeks, and 41.5% with biweekly dosing.

Turning to secondary endpoints, Dr. Simpson reported that baseline peak pruritus Numeric Rating Scale scores dropped by 19% with placebo at 16 weeks, compared with reductions of 45.5% and 47.9% with monthly and biweekly dupilumab, respectively.

An EASI 50 response,while not as impressive as an EASI 75, is nonetheless considered clinically meaningful improvement. It was attained in 12.9% on placebo and 54.8% and 61% on monthly and biweekly dupilumab.

From a mean baseline score of 13.6 on the Children’s Dermatology Life Quality Index, scores improved over the course of 16 weeks by a mean of 5.1 points with placebo, 8.5 points with monthly dupilumab, and 8.8 points with biweekly biologic therapy. The same pattern was noted with regard to the Patient-Oriented Eczema Measure or POEM.

Adverse events mirrored those documented in the pivotal trials in adults: increased rates of mild to moderate conjunctivitis: 4.7% with placebo, 10.8% with monthly dupilumab, and 9.8% with biweekly dupilumab, along with single-digit rates of injection-site reactions. As in adult AD patients, however, these side effects were counterbalanced by significantly reduced rates of skin infections in the adolescent group: 20% during 16 weeks with placebo, and 13.3% and 11% with monthly and biweekly biologic therapy, respectively.

Study participants had a mean baseline score of 12.5 on the Hospital Anxiety and Depression Scale, which is categorized as clinically significant psychiatric disease. The impact of dupilumab therapy on those scores will be the topic of a future presentation, Dr. Simpson said.

Across the board, specific outcomes were consistently numerically better in patients who received dupilumab biweekly than monthly, albeit not statistically significantly so. Dr. Simpson thinks he knows why: Lab studies showed that the mean serum concentration of functional dupilumab in patients who got the biologic biweekly was nearly twice that for the group with monthly dosing.

At first glance, the IGA “clear” or “almost clear” response rates seen with dupilumab in the adolescent study appeared to be less robust than in the adult pivotal phase 3 trials, such as the SOLO 1 and SOLO 2 trials (N Engl J Med. 2016 Dec 15;375[24]:2335-48), also led by Dr. Simpson.

“I think that’s because of the greater severity of that baseline adolescent population,” he commented. “It made for a much lower placebo response rate. But when you correct for the placebo-subtracted difference, the rates are actually pretty similar, and a lot of the other endpoints are the same or even better than in SOLO.”

After his presentation, Dr. Simpson commented, “This is huge. This is the study we’ve been waiting for.”

Elsewhere at the EADV congress, Emma Guttman-Yassky, MD, PhD, deemed the pivotal phase 3 trial in adolescent AD patients one of the meeting’s highlights. And it’s a harbinger of more good things to come, because the investigational drug pipeline for AD is full of promising candidates addressing the disease from a variety of novel directions. The long therapeutic drought in AD appears to have finally ended, observed Dr. Guttman-Yassky, professor and vice-chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Bruce Jancin/MDedge News

That’s welcome news because AD is the most common inflammatory skin disease, both in adults, where the latest data puts the prevalence at 7%-10%, and in children, where the global rate is 15%-25%.

And while at the EADV congress only the 16-week data were reported in the new adolescent study, there is reason to be optimistic that the benefits will remain durable over time. Dr. Guttman-Yassky cited the published 52-week data from the large phase 3 CHRONOS trial in adults with moderate to severe AD. In that trial, in which patients could use concomitant topical steroids, the EASI 75 rates at week 16 were 69% in patients on dupilumab at 300 mg every 2 weeks, 64% with 300 mg weekly, and 23% with placebo. Reassuringly, at 52 weeks the EASI 75 response rates were essentially unchanged: 65%, 64%, and 22% (Lancet. 2017 Jun 10;389[10086]:2287-303).

“This is what we are seeking: not just treatment that is able to quickly modify disease, but we want the treatment to be sustained, and of course we want it to be safe for our patients because we know we cannot use cyclosporine for a long time,” Dr. Guttman-Yassky said.

Dr. Simpson reported serving as a consultant to and recipient of research grants from Sanofi and Regeneron, which sponsored the adolescent study, as well as more than a dozen other pharmaceutical companies. Dr. Guttman-Yassky reported serving as an advisor and consultant, and has received grants/research funding from Regeneron, and multiple other companies.

bjancin@mdedge.com

PARIS – Dupilumab scorched its way through a landmark pivotal phase 3 clinical trial in adolescents with moderate to severe atopic dermatitis (AD), achieving unprecedented clinically meaningful improvements in signs and symptoms of the disease along with important quality of life benefits, Eric L. Simpson, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDEdge News

Indeed, dupilumab (Dupixent), a fully human monoclonal antibody that inhibits interleukins-4 and -13, demonstrated safety and efficacy in adolescent patients akin to that previously shown in adults with moderate to severe AD in phase 3 trials that earned the biologic U.S. and European regulatory approval in the adult population, noted Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.

This positive phase 3 study represents a major development in pediatric dermatology because of the pressing unmet need for better treatments for teens with moderate to severe AD whose disease can’t be controlled with topical therapies. The adolescent years are, after all, a critical period in growth and development, and a debilitating, uncontrolled disease can reshape that experience in unwelcome ways.

“Atopic dermatitis profoundly affects quality of life in adolescents and their family: The itching affects mood and sleep, these patients commonly have anxiety and depression, and the chronic and relapsing nature of the disease adversely affects the family,” the dermatologist observed.

Currently, no systemic agent is approved for pediatric patients with AD because evidence demonstrating a favorable benefit-to-risk profile has been lacking. The dupilumab study was the first-ever phase 3 trial of a biologic in such a population.

The phase 3 adolescent trial was a 16-week, randomized, double-blind, multicenter, placebo-controlled study of 251 patients aged 12-17 years with moderate to severe AD, which could not be adequately controlled with topical therapies. Participants averaged 14 years of age, with a 12-year history of AD. “These patients had the disease basically their whole life,” Dr. Simpson noted.

They were more severely affected than participants in the adult clinical trials, with mean Eczema Area And Severity Index (EASI) scores in the mid-30s and an average 56% involved body surface area. The adolescent AD patients had a heavy burden of comorbid allergic type 2 immune comorbidity: Fully 92% of them had documented asthma, food allergy, allergic rhinitis, and/or some other form of allergic comorbidity. The majority of the teens were categorized as having severe AD, whereas most participants in the adult phase 3 trials of dupilumab had moderate disease. That distinction becomes relevant in comparing the trial results.

Participants were randomized to once-monthly subcutaneous injections of dupilumab at 300 mg, following a 600-mg loading dose, or to an injection of 200 mg or 300 mg every 2 weeks with an initial dose of 400 mg or 600 mg based upon a body weight cutoff of 60 kg, or to biweekly placebo injections.

The coprimary endpoints were the proportion of patients who achieved an EASI 75 response at week 16 and achievement of an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear, on a 5-point scale at week 16.

This trial introduced an important new design feature that physicians can expect to see more of in the future: regulatory agencies now want to see the effects of monotherapy in pivotal studies in AD. Previously, participants in AD studies of systemic agents could also utilize topical steroids as needed. No longer. In the adolescent dupilumab study, resort to rescue topical steroids led to exclusion from inclusion in the primary outcome results. Not surprisingly, this lack of access to rescue medication resulted in a 60% dropout rate by 16 weeks in placebo-treated controls, a 30% dropout rate in teens on dupilumab every 4 weeks, and a 20% dropout rate with biweekly dupilumab.

The EASI 75 rate at week 16 was 8.2% with placebo, 38.1% with monthly dupilumab, and 41.5% with biweekly dosing. The other coprimary endpoint – an IGA of 0 or 1 at 16 weeks – was achieved in 2.4% of controls, 17.9% with dupilumab at 300 mg every 4 weeks, and 41.5% with biweekly dosing.

Turning to secondary endpoints, Dr. Simpson reported that baseline peak pruritus Numeric Rating Scale scores dropped by 19% with placebo at 16 weeks, compared with reductions of 45.5% and 47.9% with monthly and biweekly dupilumab, respectively.

An EASI 50 response,while not as impressive as an EASI 75, is nonetheless considered clinically meaningful improvement. It was attained in 12.9% on placebo and 54.8% and 61% on monthly and biweekly dupilumab.

From a mean baseline score of 13.6 on the Children’s Dermatology Life Quality Index, scores improved over the course of 16 weeks by a mean of 5.1 points with placebo, 8.5 points with monthly dupilumab, and 8.8 points with biweekly biologic therapy. The same pattern was noted with regard to the Patient-Oriented Eczema Measure or POEM.

Adverse events mirrored those documented in the pivotal trials in adults: increased rates of mild to moderate conjunctivitis: 4.7% with placebo, 10.8% with monthly dupilumab, and 9.8% with biweekly dupilumab, along with single-digit rates of injection-site reactions. As in adult AD patients, however, these side effects were counterbalanced by significantly reduced rates of skin infections in the adolescent group: 20% during 16 weeks with placebo, and 13.3% and 11% with monthly and biweekly biologic therapy, respectively.

Study participants had a mean baseline score of 12.5 on the Hospital Anxiety and Depression Scale, which is categorized as clinically significant psychiatric disease. The impact of dupilumab therapy on those scores will be the topic of a future presentation, Dr. Simpson said.

Across the board, specific outcomes were consistently numerically better in patients who received dupilumab biweekly than monthly, albeit not statistically significantly so. Dr. Simpson thinks he knows why: Lab studies showed that the mean serum concentration of functional dupilumab in patients who got the biologic biweekly was nearly twice that for the group with monthly dosing.

At first glance, the IGA “clear” or “almost clear” response rates seen with dupilumab in the adolescent study appeared to be less robust than in the adult pivotal phase 3 trials, such as the SOLO 1 and SOLO 2 trials (N Engl J Med. 2016 Dec 15;375[24]:2335-48), also led by Dr. Simpson.

“I think that’s because of the greater severity of that baseline adolescent population,” he commented. “It made for a much lower placebo response rate. But when you correct for the placebo-subtracted difference, the rates are actually pretty similar, and a lot of the other endpoints are the same or even better than in SOLO.”

After his presentation, Dr. Simpson commented, “This is huge. This is the study we’ve been waiting for.”

Elsewhere at the EADV congress, Emma Guttman-Yassky, MD, PhD, deemed the pivotal phase 3 trial in adolescent AD patients one of the meeting’s highlights. And it’s a harbinger of more good things to come, because the investigational drug pipeline for AD is full of promising candidates addressing the disease from a variety of novel directions. The long therapeutic drought in AD appears to have finally ended, observed Dr. Guttman-Yassky, professor and vice-chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Bruce Jancin/MDedge News

That’s welcome news because AD is the most common inflammatory skin disease, both in adults, where the latest data puts the prevalence at 7%-10%, and in children, where the global rate is 15%-25%.

And while at the EADV congress only the 16-week data were reported in the new adolescent study, there is reason to be optimistic that the benefits will remain durable over time. Dr. Guttman-Yassky cited the published 52-week data from the large phase 3 CHRONOS trial in adults with moderate to severe AD. In that trial, in which patients could use concomitant topical steroids, the EASI 75 rates at week 16 were 69% in patients on dupilumab at 300 mg every 2 weeks, 64% with 300 mg weekly, and 23% with placebo. Reassuringly, at 52 weeks the EASI 75 response rates were essentially unchanged: 65%, 64%, and 22% (Lancet. 2017 Jun 10;389[10086]:2287-303).

“This is what we are seeking: not just treatment that is able to quickly modify disease, but we want the treatment to be sustained, and of course we want it to be safe for our patients because we know we cannot use cyclosporine for a long time,” Dr. Guttman-Yassky said.

Dr. Simpson reported serving as a consultant to and recipient of research grants from Sanofi and Regeneron, which sponsored the adolescent study, as well as more than a dozen other pharmaceutical companies. Dr. Guttman-Yassky reported serving as an advisor and consultant, and has received grants/research funding from Regeneron, and multiple other companies.

bjancin@mdedge.com

PARIS – Dupilumab scorched its way through a landmark pivotal phase 3 clinical trial in adolescents with moderate to severe atopic dermatitis (AD), achieving unprecedented clinically meaningful improvements in signs and symptoms of the disease along with important quality of life benefits, Eric L. Simpson, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDEdge News

Indeed, dupilumab (Dupixent), a fully human monoclonal antibody that inhibits interleukins-4 and -13, demonstrated safety and efficacy in adolescent patients akin to that previously shown in adults with moderate to severe AD in phase 3 trials that earned the biologic U.S. and European regulatory approval in the adult population, noted Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.

This positive phase 3 study represents a major development in pediatric dermatology because of the pressing unmet need for better treatments for teens with moderate to severe AD whose disease can’t be controlled with topical therapies. The adolescent years are, after all, a critical period in growth and development, and a debilitating, uncontrolled disease can reshape that experience in unwelcome ways.

“Atopic dermatitis profoundly affects quality of life in adolescents and their family: The itching affects mood and sleep, these patients commonly have anxiety and depression, and the chronic and relapsing nature of the disease adversely affects the family,” the dermatologist observed.

Currently, no systemic agent is approved for pediatric patients with AD because evidence demonstrating a favorable benefit-to-risk profile has been lacking. The dupilumab study was the first-ever phase 3 trial of a biologic in such a population.

The phase 3 adolescent trial was a 16-week, randomized, double-blind, multicenter, placebo-controlled study of 251 patients aged 12-17 years with moderate to severe AD, which could not be adequately controlled with topical therapies. Participants averaged 14 years of age, with a 12-year history of AD. “These patients had the disease basically their whole life,” Dr. Simpson noted.

They were more severely affected than participants in the adult clinical trials, with mean Eczema Area And Severity Index (EASI) scores in the mid-30s and an average 56% involved body surface area. The adolescent AD patients had a heavy burden of comorbid allergic type 2 immune comorbidity: Fully 92% of them had documented asthma, food allergy, allergic rhinitis, and/or some other form of allergic comorbidity. The majority of the teens were categorized as having severe AD, whereas most participants in the adult phase 3 trials of dupilumab had moderate disease. That distinction becomes relevant in comparing the trial results.

Participants were randomized to once-monthly subcutaneous injections of dupilumab at 300 mg, following a 600-mg loading dose, or to an injection of 200 mg or 300 mg every 2 weeks with an initial dose of 400 mg or 600 mg based upon a body weight cutoff of 60 kg, or to biweekly placebo injections.

The coprimary endpoints were the proportion of patients who achieved an EASI 75 response at week 16 and achievement of an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear, on a 5-point scale at week 16.

This trial introduced an important new design feature that physicians can expect to see more of in the future: regulatory agencies now want to see the effects of monotherapy in pivotal studies in AD. Previously, participants in AD studies of systemic agents could also utilize topical steroids as needed. No longer. In the adolescent dupilumab study, resort to rescue topical steroids led to exclusion from inclusion in the primary outcome results. Not surprisingly, this lack of access to rescue medication resulted in a 60% dropout rate by 16 weeks in placebo-treated controls, a 30% dropout rate in teens on dupilumab every 4 weeks, and a 20% dropout rate with biweekly dupilumab.

The EASI 75 rate at week 16 was 8.2% with placebo, 38.1% with monthly dupilumab, and 41.5% with biweekly dosing. The other coprimary endpoint – an IGA of 0 or 1 at 16 weeks – was achieved in 2.4% of controls, 17.9% with dupilumab at 300 mg every 4 weeks, and 41.5% with biweekly dosing.

Turning to secondary endpoints, Dr. Simpson reported that baseline peak pruritus Numeric Rating Scale scores dropped by 19% with placebo at 16 weeks, compared with reductions of 45.5% and 47.9% with monthly and biweekly dupilumab, respectively.

An EASI 50 response,while not as impressive as an EASI 75, is nonetheless considered clinically meaningful improvement. It was attained in 12.9% on placebo and 54.8% and 61% on monthly and biweekly dupilumab.

From a mean baseline score of 13.6 on the Children’s Dermatology Life Quality Index, scores improved over the course of 16 weeks by a mean of 5.1 points with placebo, 8.5 points with monthly dupilumab, and 8.8 points with biweekly biologic therapy. The same pattern was noted with regard to the Patient-Oriented Eczema Measure or POEM.

Adverse events mirrored those documented in the pivotal trials in adults: increased rates of mild to moderate conjunctivitis: 4.7% with placebo, 10.8% with monthly dupilumab, and 9.8% with biweekly dupilumab, along with single-digit rates of injection-site reactions. As in adult AD patients, however, these side effects were counterbalanced by significantly reduced rates of skin infections in the adolescent group: 20% during 16 weeks with placebo, and 13.3% and 11% with monthly and biweekly biologic therapy, respectively.

Study participants had a mean baseline score of 12.5 on the Hospital Anxiety and Depression Scale, which is categorized as clinically significant psychiatric disease. The impact of dupilumab therapy on those scores will be the topic of a future presentation, Dr. Simpson said.

Across the board, specific outcomes were consistently numerically better in patients who received dupilumab biweekly than monthly, albeit not statistically significantly so. Dr. Simpson thinks he knows why: Lab studies showed that the mean serum concentration of functional dupilumab in patients who got the biologic biweekly was nearly twice that for the group with monthly dosing.

At first glance, the IGA “clear” or “almost clear” response rates seen with dupilumab in the adolescent study appeared to be less robust than in the adult pivotal phase 3 trials, such as the SOLO 1 and SOLO 2 trials (N Engl J Med. 2016 Dec 15;375[24]:2335-48), also led by Dr. Simpson.

“I think that’s because of the greater severity of that baseline adolescent population,” he commented. “It made for a much lower placebo response rate. But when you correct for the placebo-subtracted difference, the rates are actually pretty similar, and a lot of the other endpoints are the same or even better than in SOLO.”

After his presentation, Dr. Simpson commented, “This is huge. This is the study we’ve been waiting for.”

Elsewhere at the EADV congress, Emma Guttman-Yassky, MD, PhD, deemed the pivotal phase 3 trial in adolescent AD patients one of the meeting’s highlights. And it’s a harbinger of more good things to come, because the investigational drug pipeline for AD is full of promising candidates addressing the disease from a variety of novel directions. The long therapeutic drought in AD appears to have finally ended, observed Dr. Guttman-Yassky, professor and vice-chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Bruce Jancin/MDedge News

That’s welcome news because AD is the most common inflammatory skin disease, both in adults, where the latest data puts the prevalence at 7%-10%, and in children, where the global rate is 15%-25%.

And while at the EADV congress only the 16-week data were reported in the new adolescent study, there is reason to be optimistic that the benefits will remain durable over time. Dr. Guttman-Yassky cited the published 52-week data from the large phase 3 CHRONOS trial in adults with moderate to severe AD. In that trial, in which patients could use concomitant topical steroids, the EASI 75 rates at week 16 were 69% in patients on dupilumab at 300 mg every 2 weeks, 64% with 300 mg weekly, and 23% with placebo. Reassuringly, at 52 weeks the EASI 75 response rates were essentially unchanged: 65%, 64%, and 22% (Lancet. 2017 Jun 10;389[10086]:2287-303).

“This is what we are seeking: not just treatment that is able to quickly modify disease, but we want the treatment to be sustained, and of course we want it to be safe for our patients because we know we cannot use cyclosporine for a long time,” Dr. Guttman-Yassky said.

Dr. Simpson reported serving as a consultant to and recipient of research grants from Sanofi and Regeneron, which sponsored the adolescent study, as well as more than a dozen other pharmaceutical companies. Dr. Guttman-Yassky reported serving as an advisor and consultant, and has received grants/research funding from Regeneron, and multiple other companies.

bjancin@mdedge.com

We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).

Aunt_Spray/Thinkstock

There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.¹

According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.²

The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.

HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.

Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.

It is imperative that we educate our adolescent patients on risk and how to prevent contracting HSV. It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.

2. NCHS Data Brief, no 304. 2018 Feb.

We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).

Aunt_Spray/Thinkstock

There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.¹

According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.²

The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.

HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.

Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.

It is imperative that we educate our adolescent patients on risk and how to prevent contracting HSV. It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.

2. NCHS Data Brief, no 304. 2018 Feb.

We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).

Aunt_Spray/Thinkstock

There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.¹

According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.²

The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.

HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.

Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.

It is imperative that we educate our adolescent patients on risk and how to prevent contracting HSV. It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

References

1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.

2. NCHS Data Brief, no 304. 2018 Feb.

Photo courtesy of Amgen

The Japanese Ministry of Health, Labour and Welfare has approved blinatumomab (Blincyto®) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Blinatumomab is the first and only bispecific T-cell engager immunotherapy construct approved globally.

The drug’s approval in Japan is based on data from the phase 3 TOWER study and the phase 1b/2 Horai study.

The TOWER trial (NCT02013167) enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.

The patients received blinatumomab (n=267) or investigator’s choice of four protocol-defined standard of care (SOC) chemotherapy regimens (n=109):

• FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
• A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
• A high-dose methotrexate-based regimen (n=22, 20%)
• A clofarabine-based regimen (n=19, 17%).

Blinatumomab demonstrated an improvement in median overall survival over SOC. The median overall survival was 7.7 months with blinatumomab and 4.0 months with SOC (hazard ratio for death=0.71; P=0.012).

Grade 3 or higher adverse events (AEs) of interest, according to the researchers, were:

• Infection (34% with blinatumomab and 52% with chemotherapy)
• Neutropenia (38% and 58%, respectively)
• Elevated liver enzymes (13% and 15%, respectively)
• Neurologic events (9% and 8%, respectively)
• Cytokine release syndrome (5% and 0%, respectively)
• Infusion reactions (3% and 1%, respectively)
• Lymphopenia (2% and 4%, respectively).

Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the SOC arm.

These results were published in The New England Journal of Medicine last year.

Horai

For this single-arm trial (NCT02412306), researchers evaluated blinatumomab in 35 Japanese adult and pediatric patients with relapsed or refractory B-ALL. An extension of this study is ongoing.

Efficacy data from Horai are not available.

According to Amgen, the major AEs occurring in adults on this trial were cytokine release syndrome (46.2%), pyrexia (46.2%), decrease in white blood cell count (38.5%), and decrease in platelet count (34.6%).

Major AEs in pediatric patients were elevated liver enzymes (66.7%), pyrexia (66.7%), cytokine release syndrome (55.6%), and abdominal pain (44.4%).

Photo courtesy of Amgen

The Japanese Ministry of Health, Labour and Welfare has approved blinatumomab (Blincyto®) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Blinatumomab is the first and only bispecific T-cell engager immunotherapy construct approved globally.

The drug’s approval in Japan is based on data from the phase 3 TOWER study and the phase 1b/2 Horai study.

The TOWER trial (NCT02013167) enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.

The patients received blinatumomab (n=267) or investigator’s choice of four protocol-defined standard of care (SOC) chemotherapy regimens (n=109):

• FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
• A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
• A high-dose methotrexate-based regimen (n=22, 20%)
• A clofarabine-based regimen (n=19, 17%).

Blinatumomab demonstrated an improvement in median overall survival over SOC. The median overall survival was 7.7 months with blinatumomab and 4.0 months with SOC (hazard ratio for death=0.71; P=0.012).

Grade 3 or higher adverse events (AEs) of interest, according to the researchers, were:

• Infection (34% with blinatumomab and 52% with chemotherapy)
• Neutropenia (38% and 58%, respectively)
• Elevated liver enzymes (13% and 15%, respectively)
• Neurologic events (9% and 8%, respectively)
• Cytokine release syndrome (5% and 0%, respectively)
• Infusion reactions (3% and 1%, respectively)
• Lymphopenia (2% and 4%, respectively).

Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the SOC arm.

These results were published in The New England Journal of Medicine last year.

Horai

For this single-arm trial (NCT02412306), researchers evaluated blinatumomab in 35 Japanese adult and pediatric patients with relapsed or refractory B-ALL. An extension of this study is ongoing.

Efficacy data from Horai are not available.

According to Amgen, the major AEs occurring in adults on this trial were cytokine release syndrome (46.2%), pyrexia (46.2%), decrease in white blood cell count (38.5%), and decrease in platelet count (34.6%).

Major AEs in pediatric patients were elevated liver enzymes (66.7%), pyrexia (66.7%), cytokine release syndrome (55.6%), and abdominal pain (44.4%).

Photo courtesy of Amgen

The Japanese Ministry of Health, Labour and Welfare has approved blinatumomab (Blincyto®) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Blinatumomab is the first and only bispecific T-cell engager immunotherapy construct approved globally.

The drug’s approval in Japan is based on data from the phase 3 TOWER study and the phase 1b/2 Horai study.

The TOWER trial (NCT02013167) enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.

The patients received blinatumomab (n=267) or investigator’s choice of four protocol-defined standard of care (SOC) chemotherapy regimens (n=109):

• FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
• A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
• A high-dose methotrexate-based regimen (n=22, 20%)
• A clofarabine-based regimen (n=19, 17%).

Blinatumomab demonstrated an improvement in median overall survival over SOC. The median overall survival was 7.7 months with blinatumomab and 4.0 months with SOC (hazard ratio for death=0.71; P=0.012).

Grade 3 or higher adverse events (AEs) of interest, according to the researchers, were:

• Infection (34% with blinatumomab and 52% with chemotherapy)
• Neutropenia (38% and 58%, respectively)
• Elevated liver enzymes (13% and 15%, respectively)
• Neurologic events (9% and 8%, respectively)
• Cytokine release syndrome (5% and 0%, respectively)
• Infusion reactions (3% and 1%, respectively)
• Lymphopenia (2% and 4%, respectively).

Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the SOC arm.

These results were published in The New England Journal of Medicine last year.

Horai

For this single-arm trial (NCT02412306), researchers evaluated blinatumomab in 35 Japanese adult and pediatric patients with relapsed or refractory B-ALL. An extension of this study is ongoing.

Efficacy data from Horai are not available.

According to Amgen, the major AEs occurring in adults on this trial were cytokine release syndrome (46.2%), pyrexia (46.2%), decrease in white blood cell count (38.5%), and decrease in platelet count (34.6%).

Major AEs in pediatric patients were elevated liver enzymes (66.7%), pyrexia (66.7%), cytokine release syndrome (55.6%), and abdominal pain (44.4%).

At the visit, the girl’s skin scrapings were analyzed under the microscope with potassium hydroxide (KOH) and no fungal elements were seen. A culture from one of the lesions was positive for methicillin-sensitive Staphylococcus aureus.

She was diagnosed with bullous impetigo (BI).

Impetigo is the most common superficial skin infection and can present as a nonbullous (most common) and bullous (least common) form.¹ Nonbullous impetigo is usually caused the Staphylococcus aureus or Streptococcus pyogenes and tends to occur at sites of prior trauma like insect bites, scratches, atopic dermatitis, or varicella. On the other hand, bullous impetigo is caused by the local production of exfoliative toxins (ETA or ETB) by phage group II of Staphylococcus aureus. The exfoliative toxin binds to desmoglin-1, one of the desmosomal proteins of the skin, causing acantholysis at the level of the granular layer and blister formation. Different from nonbullous impetigo, bullous impetigo tends to occur in normal, undamaged skin. Lesions are more common in neonates and young infants but children also can be affected.

The characteristic lesions in bullous impetigo are small blisters that enlarge to 1-cm to 5-cm bullae that easily rupture, leaving an erythematous plaque with a collarette of scale or “double ring scale,” with minimal crust and mild erythema. They commonly occur on the face, trunk, buttocks, and intertriginous areas. The lesions heal within 4-6 weeks, leaving no scarring. Associated systemic symptoms are rare but some patients can present with weakness, fever, and diarrhea. The toxin can disseminate and cause staphylococcal scalded skin syndrome in neonates or older patients with renal failure or immunodeficiency.

The transmission of Staphylococcus aureus can occur from colonized or infected family members, children in contact sports, as well as contact with animals such as dogs, cattle, and poultry.² Transmission from a pet rabbit also has been reported. In our patient, transmission from her pet hamster could have occurred as the areas on the body where there were lesions were areas where she was holding and cuddling her new pet.

The differential diagnosis of the type of lesions our patient presented with includes tinea corporis, and bullous tinea, which also can be transmitted by animals such as kittens. A KOH analysis ruled out this diagnosis. Tinea skin lesions tend to be more scaly than bullous impetigo lesions, which are more inflamed and crusted. Bullous arthropod reactions should be considered in the differential diagnosis as well. Bullous bite reaction lesions present with tense bullae, as they are subepidermal in nature and are pruritic. Subacute cutaneous lupus lesions present as annular scaly plaques with an erythematous border and central clearing usually in sun exposed areas similar to the distribution of our patient. Severe contact dermatitis reactions also can blister and form similar lesions as seen in our patient but with the difference that our patient didn’t complain of pruritus, which is a characteristic feature of allergic contact dermatitis. In neonates or young infants with bullous lesions other conditions such as herpes simplex infection, epidermolysis bullosa, bullous pemphigoid, linear IgA bullous dermatosis, bullous mastocytosis, and bullous erythema multiforme should be considered in the differential diagnosis.

First line treatment for impetigo consists of the use of topical application of mupirocin (Bactroban) 2% ointment, retapamulin (Altabax) 1% ointment, or fusidic acid 2% cream. A Cochrane review compared systemic versus topical treatment for impetigo concluding that topical treatment with either mupirocin or retapamulin is equally if not more effective than oral antibiotics.³ Ozenoxacin (Xepi), a new nonfluorinated topical quinolone has recently been Food and Drug Administration approved for the treatment of localized impetigo in patients 2 months of age and older.⁴ When there is treatment failure with topical antibiotics, widespread disease, or systemic symptoms, oral antimicrobials should be consider, such as beta-lactamase–resistant penicillin, first-generation cephalosporins, or clindamycin. The use of bleach baths and general hygiene measures for 4 months can reduce the risks of recurrence in 20% of the patients as noted by a study by Kaplan et al.⁵

Our patient was treated with oral cephalexin for 7 days as well as topical mupirocin with fast resolution of the lesions. Sadly, the parents gave her hamster pet away.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at pdnews@mdedge.com

References

1. Am Fam Physician. 2014 Aug 15;90(4):229-35.

2. Zentralbl Bakteriol Mikrobiol Hyg A. 1987 Jun;265(1-2):218-26.

3. Cochrane Database Syst Rev. 2012 Jan 18;1:CD003261.

4. Ann Pharmacother. 2018 Jun 1:1060028018786510.

5. Clin Infect Dis. 2014 Mar;58(5):679-82.

At the visit, the girl’s skin scrapings were analyzed under the microscope with potassium hydroxide (KOH) and no fungal elements were seen. A culture from one of the lesions was positive for methicillin-sensitive Staphylococcus aureus.

She was diagnosed with bullous impetigo (BI).

Impetigo is the most common superficial skin infection and can present as a nonbullous (most common) and bullous (least common) form.¹ Nonbullous impetigo is usually caused the Staphylococcus aureus or Streptococcus pyogenes and tends to occur at sites of prior trauma like insect bites, scratches, atopic dermatitis, or varicella. On the other hand, bullous impetigo is caused by the local production of exfoliative toxins (ETA or ETB) by phage group II of Staphylococcus aureus. The exfoliative toxin binds to desmoglin-1, one of the desmosomal proteins of the skin, causing acantholysis at the level of the granular layer and blister formation. Different from nonbullous impetigo, bullous impetigo tends to occur in normal, undamaged skin. Lesions are more common in neonates and young infants but children also can be affected.

The characteristic lesions in bullous impetigo are small blisters that enlarge to 1-cm to 5-cm bullae that easily rupture, leaving an erythematous plaque with a collarette of scale or “double ring scale,” with minimal crust and mild erythema. They commonly occur on the face, trunk, buttocks, and intertriginous areas. The lesions heal within 4-6 weeks, leaving no scarring. Associated systemic symptoms are rare but some patients can present with weakness, fever, and diarrhea. The toxin can disseminate and cause staphylococcal scalded skin syndrome in neonates or older patients with renal failure or immunodeficiency.

The transmission of Staphylococcus aureus can occur from colonized or infected family members, children in contact sports, as well as contact with animals such as dogs, cattle, and poultry.² Transmission from a pet rabbit also has been reported. In our patient, transmission from her pet hamster could have occurred as the areas on the body where there were lesions were areas where she was holding and cuddling her new pet.

The differential diagnosis of the type of lesions our patient presented with includes tinea corporis, and bullous tinea, which also can be transmitted by animals such as kittens. A KOH analysis ruled out this diagnosis. Tinea skin lesions tend to be more scaly than bullous impetigo lesions, which are more inflamed and crusted. Bullous arthropod reactions should be considered in the differential diagnosis as well. Bullous bite reaction lesions present with tense bullae, as they are subepidermal in nature and are pruritic. Subacute cutaneous lupus lesions present as annular scaly plaques with an erythematous border and central clearing usually in sun exposed areas similar to the distribution of our patient. Severe contact dermatitis reactions also can blister and form similar lesions as seen in our patient but with the difference that our patient didn’t complain of pruritus, which is a characteristic feature of allergic contact dermatitis. In neonates or young infants with bullous lesions other conditions such as herpes simplex infection, epidermolysis bullosa, bullous pemphigoid, linear IgA bullous dermatosis, bullous mastocytosis, and bullous erythema multiforme should be considered in the differential diagnosis.

First line treatment for impetigo consists of the use of topical application of mupirocin (Bactroban) 2% ointment, retapamulin (Altabax) 1% ointment, or fusidic acid 2% cream. A Cochrane review compared systemic versus topical treatment for impetigo concluding that topical treatment with either mupirocin or retapamulin is equally if not more effective than oral antibiotics.³ Ozenoxacin (Xepi), a new nonfluorinated topical quinolone has recently been Food and Drug Administration approved for the treatment of localized impetigo in patients 2 months of age and older.⁴ When there is treatment failure with topical antibiotics, widespread disease, or systemic symptoms, oral antimicrobials should be consider, such as beta-lactamase–resistant penicillin, first-generation cephalosporins, or clindamycin. The use of bleach baths and general hygiene measures for 4 months can reduce the risks of recurrence in 20% of the patients as noted by a study by Kaplan et al.⁵

Our patient was treated with oral cephalexin for 7 days as well as topical mupirocin with fast resolution of the lesions. Sadly, the parents gave her hamster pet away.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at pdnews@mdedge.com

References

1. Am Fam Physician. 2014 Aug 15;90(4):229-35.

2. Zentralbl Bakteriol Mikrobiol Hyg A. 1987 Jun;265(1-2):218-26.

3. Cochrane Database Syst Rev. 2012 Jan 18;1:CD003261.

4. Ann Pharmacother. 2018 Jun 1:1060028018786510.

5. Clin Infect Dis. 2014 Mar;58(5):679-82.

At the visit, the girl’s skin scrapings were analyzed under the microscope with potassium hydroxide (KOH) and no fungal elements were seen. A culture from one of the lesions was positive for methicillin-sensitive Staphylococcus aureus.

She was diagnosed with bullous impetigo (BI).

Impetigo is the most common superficial skin infection and can present as a nonbullous (most common) and bullous (least common) form.¹ Nonbullous impetigo is usually caused the Staphylococcus aureus or Streptococcus pyogenes and tends to occur at sites of prior trauma like insect bites, scratches, atopic dermatitis, or varicella. On the other hand, bullous impetigo is caused by the local production of exfoliative toxins (ETA or ETB) by phage group II of Staphylococcus aureus. The exfoliative toxin binds to desmoglin-1, one of the desmosomal proteins of the skin, causing acantholysis at the level of the granular layer and blister formation. Different from nonbullous impetigo, bullous impetigo tends to occur in normal, undamaged skin. Lesions are more common in neonates and young infants but children also can be affected.

The characteristic lesions in bullous impetigo are small blisters that enlarge to 1-cm to 5-cm bullae that easily rupture, leaving an erythematous plaque with a collarette of scale or “double ring scale,” with minimal crust and mild erythema. They commonly occur on the face, trunk, buttocks, and intertriginous areas. The lesions heal within 4-6 weeks, leaving no scarring. Associated systemic symptoms are rare but some patients can present with weakness, fever, and diarrhea. The toxin can disseminate and cause staphylococcal scalded skin syndrome in neonates or older patients with renal failure or immunodeficiency.

The transmission of Staphylococcus aureus can occur from colonized or infected family members, children in contact sports, as well as contact with animals such as dogs, cattle, and poultry.² Transmission from a pet rabbit also has been reported. In our patient, transmission from her pet hamster could have occurred as the areas on the body where there were lesions were areas where she was holding and cuddling her new pet.

The differential diagnosis of the type of lesions our patient presented with includes tinea corporis, and bullous tinea, which also can be transmitted by animals such as kittens. A KOH analysis ruled out this diagnosis. Tinea skin lesions tend to be more scaly than bullous impetigo lesions, which are more inflamed and crusted. Bullous arthropod reactions should be considered in the differential diagnosis as well. Bullous bite reaction lesions present with tense bullae, as they are subepidermal in nature and are pruritic. Subacute cutaneous lupus lesions present as annular scaly plaques with an erythematous border and central clearing usually in sun exposed areas similar to the distribution of our patient. Severe contact dermatitis reactions also can blister and form similar lesions as seen in our patient but with the difference that our patient didn’t complain of pruritus, which is a characteristic feature of allergic contact dermatitis. In neonates or young infants with bullous lesions other conditions such as herpes simplex infection, epidermolysis bullosa, bullous pemphigoid, linear IgA bullous dermatosis, bullous mastocytosis, and bullous erythema multiforme should be considered in the differential diagnosis.

First line treatment for impetigo consists of the use of topical application of mupirocin (Bactroban) 2% ointment, retapamulin (Altabax) 1% ointment, or fusidic acid 2% cream. A Cochrane review compared systemic versus topical treatment for impetigo concluding that topical treatment with either mupirocin or retapamulin is equally if not more effective than oral antibiotics.³ Ozenoxacin (Xepi), a new nonfluorinated topical quinolone has recently been Food and Drug Administration approved for the treatment of localized impetigo in patients 2 months of age and older.⁴ When there is treatment failure with topical antibiotics, widespread disease, or systemic symptoms, oral antimicrobials should be consider, such as beta-lactamase–resistant penicillin, first-generation cephalosporins, or clindamycin. The use of bleach baths and general hygiene measures for 4 months can reduce the risks of recurrence in 20% of the patients as noted by a study by Kaplan et al.⁵

Our patient was treated with oral cephalexin for 7 days as well as topical mupirocin with fast resolution of the lesions. Sadly, the parents gave her hamster pet away.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at pdnews@mdedge.com

References

1. Am Fam Physician. 2014 Aug 15;90(4):229-35.

2. Zentralbl Bakteriol Mikrobiol Hyg A. 1987 Jun;265(1-2):218-26.

3. Cochrane Database Syst Rev. 2012 Jan 18;1:CD003261.

4. Ann Pharmacother. 2018 Jun 1:1060028018786510.

5. Clin Infect Dis. 2014 Mar;58(5):679-82.

IDWeek 2018 includes the annual meeting of the Pediatric Infectious Diseases Society, which is celebrating its 40th anniversary as a society this year.

Paul Spearman, MD, the PIDS president, specifically highlighted some of the special 40th anniversary events: The Stanley A. Plotkin Lectureship in Vaccinology will be held on Friday, Oct. 5. “This is an annual highlight for PIDS in honor of Stanley Plotkin, the founder of PIDS and [an] inspiration to all of us. We are delighted to have Gary Marshall as the speaker this year giving a talk entitled “Vaccine Hesitancy, History and Human Nature,” Dr. Spearman wrote in an article posted on the PIDS website.

He noted that the PIDS anniversary special celebration, dinner, and lecture in honor of the contributions of George McCracken and John Nelson also will be held Oct. 5.

Throughout the meeting, the latest data and practices for the treatment of infants and children will be featured. Although pediatric issues will be discussed in many sessions, there are a number of events specifically dedicated to pediatric cases.

Of particular interest, on Wednesday morning, Oral Abstract Session 31 will focus on “Infant Viral Infections.” Talks will include “Role of Maternal Antibodies in Protection Against Postnatal Cytomegalovirus Acquisition,” by Frances Saccoccio, MD, PhD, and “Effect of Nasopharyngeal Pneumococcal Carriage on RSV and hMPV Illness Severity in Infants in Nepal,” by Alastair Murray.

On Thursday morning, the symposium “Hot Topics in Pediatric Infectious Diseases” will feature talks by experts in the field detailing this year’s important clinical advances and discoveries that have the potential to impact clinical care.

The Thursday afternoon poster session “Pediatric Antimicrobial and Diagnostic Stewardship” will focus on topics such as “Variation in Antibiotic Use Among Neonates Hospitalized in United States Academically Affiliated Centers,” which will be presented by Prachi Singh, DO, and “Alternative Antibiotic Prescribing for Community Acquired Pneumonia (CAP) in Pediatric Patients in Relation to Allergy Status,” to be presented by Ankita Desai, MD.

There also will be a poster session that afternoon focused on “Maternal-Child Infections” that will feature “Risk Factors for Congenital Infection in the United States: Analysis of the Kids’ Inpatient Database (KID),” by Angela F. Veesenmeyer, MD, and “The Effect of Prenatal Screening for Chlamydia trachomatis (CT) on Chlamydial Conjunctivitis in Infants,” by Natalie Banniettis, MD.

Later that same day, “Mano-a-Mano III,” an interactive session on “Controversies in Pediatric ID,” will focus on the tuberculin skin test vs. the interferon-gamma release assay (IGRA) for TB identification, the use of vancomycin therapy for meningitis, and the value of respiratory viral panel testing.

As part of the program committee, Marsha S. Anderson, MD, FIDSA, from the University of Colorado School of Medicine, serves as this year’s IDWeek chair, for the PIDS portion of the meeting, and Roberta L. DeBiasi, MD, of the Children’s National Health System serves as vice chair.

IDWeek 2018 includes the annual meeting of the Pediatric Infectious Diseases Society, which is celebrating its 40th anniversary as a society this year.

Paul Spearman, MD, the PIDS president, specifically highlighted some of the special 40th anniversary events: The Stanley A. Plotkin Lectureship in Vaccinology will be held on Friday, Oct. 5. “This is an annual highlight for PIDS in honor of Stanley Plotkin, the founder of PIDS and [an] inspiration to all of us. We are delighted to have Gary Marshall as the speaker this year giving a talk entitled “Vaccine Hesitancy, History and Human Nature,” Dr. Spearman wrote in an article posted on the PIDS website.

He noted that the PIDS anniversary special celebration, dinner, and lecture in honor of the contributions of George McCracken and John Nelson also will be held Oct. 5.

Throughout the meeting, the latest data and practices for the treatment of infants and children will be featured. Although pediatric issues will be discussed in many sessions, there are a number of events specifically dedicated to pediatric cases.

Of particular interest, on Wednesday morning, Oral Abstract Session 31 will focus on “Infant Viral Infections.” Talks will include “Role of Maternal Antibodies in Protection Against Postnatal Cytomegalovirus Acquisition,” by Frances Saccoccio, MD, PhD, and “Effect of Nasopharyngeal Pneumococcal Carriage on RSV and hMPV Illness Severity in Infants in Nepal,” by Alastair Murray.

On Thursday morning, the symposium “Hot Topics in Pediatric Infectious Diseases” will feature talks by experts in the field detailing this year’s important clinical advances and discoveries that have the potential to impact clinical care.

The Thursday afternoon poster session “Pediatric Antimicrobial and Diagnostic Stewardship” will focus on topics such as “Variation in Antibiotic Use Among Neonates Hospitalized in United States Academically Affiliated Centers,” which will be presented by Prachi Singh, DO, and “Alternative Antibiotic Prescribing for Community Acquired Pneumonia (CAP) in Pediatric Patients in Relation to Allergy Status,” to be presented by Ankita Desai, MD.

There also will be a poster session that afternoon focused on “Maternal-Child Infections” that will feature “Risk Factors for Congenital Infection in the United States: Analysis of the Kids’ Inpatient Database (KID),” by Angela F. Veesenmeyer, MD, and “The Effect of Prenatal Screening for Chlamydia trachomatis (CT) on Chlamydial Conjunctivitis in Infants,” by Natalie Banniettis, MD.

Later that same day, “Mano-a-Mano III,” an interactive session on “Controversies in Pediatric ID,” will focus on the tuberculin skin test vs. the interferon-gamma release assay (IGRA) for TB identification, the use of vancomycin therapy for meningitis, and the value of respiratory viral panel testing.

As part of the program committee, Marsha S. Anderson, MD, FIDSA, from the University of Colorado School of Medicine, serves as this year’s IDWeek chair, for the PIDS portion of the meeting, and Roberta L. DeBiasi, MD, of the Children’s National Health System serves as vice chair.

IDWeek 2018 includes the annual meeting of the Pediatric Infectious Diseases Society, which is celebrating its 40th anniversary as a society this year.

Paul Spearman, MD, the PIDS president, specifically highlighted some of the special 40th anniversary events: The Stanley A. Plotkin Lectureship in Vaccinology will be held on Friday, Oct. 5. “This is an annual highlight for PIDS in honor of Stanley Plotkin, the founder of PIDS and [an] inspiration to all of us. We are delighted to have Gary Marshall as the speaker this year giving a talk entitled “Vaccine Hesitancy, History and Human Nature,” Dr. Spearman wrote in an article posted on the PIDS website.

He noted that the PIDS anniversary special celebration, dinner, and lecture in honor of the contributions of George McCracken and John Nelson also will be held Oct. 5.

Throughout the meeting, the latest data and practices for the treatment of infants and children will be featured. Although pediatric issues will be discussed in many sessions, there are a number of events specifically dedicated to pediatric cases.

Of particular interest, on Wednesday morning, Oral Abstract Session 31 will focus on “Infant Viral Infections.” Talks will include “Role of Maternal Antibodies in Protection Against Postnatal Cytomegalovirus Acquisition,” by Frances Saccoccio, MD, PhD, and “Effect of Nasopharyngeal Pneumococcal Carriage on RSV and hMPV Illness Severity in Infants in Nepal,” by Alastair Murray.

On Thursday morning, the symposium “Hot Topics in Pediatric Infectious Diseases” will feature talks by experts in the field detailing this year’s important clinical advances and discoveries that have the potential to impact clinical care.

The Thursday afternoon poster session “Pediatric Antimicrobial and Diagnostic Stewardship” will focus on topics such as “Variation in Antibiotic Use Among Neonates Hospitalized in United States Academically Affiliated Centers,” which will be presented by Prachi Singh, DO, and “Alternative Antibiotic Prescribing for Community Acquired Pneumonia (CAP) in Pediatric Patients in Relation to Allergy Status,” to be presented by Ankita Desai, MD.

There also will be a poster session that afternoon focused on “Maternal-Child Infections” that will feature “Risk Factors for Congenital Infection in the United States: Analysis of the Kids’ Inpatient Database (KID),” by Angela F. Veesenmeyer, MD, and “The Effect of Prenatal Screening for Chlamydia trachomatis (CT) on Chlamydial Conjunctivitis in Infants,” by Natalie Banniettis, MD.

Later that same day, “Mano-a-Mano III,” an interactive session on “Controversies in Pediatric ID,” will focus on the tuberculin skin test vs. the interferon-gamma release assay (IGRA) for TB identification, the use of vancomycin therapy for meningitis, and the value of respiratory viral panel testing.

As part of the program committee, Marsha S. Anderson, MD, FIDSA, from the University of Colorado School of Medicine, serves as this year’s IDWeek chair, for the PIDS portion of the meeting, and Roberta L. DeBiasi, MD, of the Children’s National Health System serves as vice chair.

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

bjancin@mdedge.com

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

bjancin@mdedge.com

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

bjancin@mdedge.com

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats