Sharon Worcester

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

No significant differences were seen in the risk of adverse neonatal outcomes between women with twin pregnancy who underwent planned cesarean delivery and those who underwent planned vaginal delivery as part of the randomized Twin Birth Study.

The rate of a composite outcome of fetal or neonatal death or serious neonatal morbidity among 1,393 women in 25 countries assigned to undergo planned cesarean delivery was 2.2%, compared with 1.9% among 1,393 women assigned to planned vaginal delivery (odds ratio with planned cesarean delivery, 1.16), Dr. Jon F.R. Barrett of Sunnybrook Health Sciences Centre, Toronto, and his colleagues reported on behalf of the Twin Birth Study Collaborative Group.

Another outcome – a composite of maternal death or serious maternal morbidity – also did not differ between the groups, occurring in 7.3% of the cesarean group and 8.5% of the vaginal delivery group. This finding, however, may be explained in part by the high rate of cesarean section in the planned vaginal delivery group, they said (N. Engl. J. Med. 2013;369:1295-305).

© MichaelBlackburn/iStockphoto.com

Secondary outcomes, including death or a poor neurodevelopmental outcome among the children at 2 years and problematic incontinence among the mothers at 2 years, will be reported subsequently.

Participants in the Twin Birth Study were women between 32 weeks 0 days gestation and 38 weeks 6 days gestation between Dec. 13, 2003, and April 4, 2011, who were pregnant with twins with an estimated weight of between 1,500 g and 4,000 g each and whose first twin was in the cephalic presentation. The women were randomized to planned cesarean delivery or vaginal delivery with cesarean only if indicated and were followed until 28 days after delivery.

Most (90.7%) in the cesarean delivery group delivered by cesarean as planned, and 43.8% in the planned vaginal delivery group required cesarean delivery, the investigators said

The findings are of note because the twin pregnancy rate has increased over time, largely due to assisted reproductive technologies, and the rate of cesarean section for twins also has increased in the wake of studies suggesting a possible benefit of cesarean delivery with respect to perinatal outcomes.

"There are several possible reasons why our results differ from previous observational data: we avoided selection bias, we ensured the presence of an experienced obstetrician at delivery, and many of the twins in our study were born preterm," the investigators said, adding that no significant interaction between treatment group and baseline variables was seen, which suggests that no significant benefit occurred with planned cesarean delivery for any subgroup tested.

"However, our study was not powered for these subgroup analyses. Further study may be warranted for the gestational-age subgroup of 37 to 38 weeks, particularly given the limited number of infants in this subgroup," they said.

Overall, the results of this study are consistent with no more than a 23% reduction and no more than a 74% increase in the odds of fetal or neonatal death or serious neonatal morbidity with planned cesarean vs. planned vaginal delivery, they said.

"In conclusion, we found no benefits of planned cesarean section, as compared with planned vaginal delivery, for the delivery of twins between 32 and 38 weeks of gestation, if the first twin was in the cephalic presentation," they wrote.

This study was supported by a grant from the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.

No significant differences were seen in the risk of adverse neonatal outcomes between women with twin pregnancy who underwent planned cesarean delivery and those who underwent planned vaginal delivery as part of the randomized Twin Birth Study.

The rate of a composite outcome of fetal or neonatal death or serious neonatal morbidity among 1,393 women in 25 countries assigned to undergo planned cesarean delivery was 2.2%, compared with 1.9% among 1,393 women assigned to planned vaginal delivery (odds ratio with planned cesarean delivery, 1.16), Dr. Jon F.R. Barrett of Sunnybrook Health Sciences Centre, Toronto, and his colleagues reported on behalf of the Twin Birth Study Collaborative Group.

Another outcome – a composite of maternal death or serious maternal morbidity – also did not differ between the groups, occurring in 7.3% of the cesarean group and 8.5% of the vaginal delivery group. This finding, however, may be explained in part by the high rate of cesarean section in the planned vaginal delivery group, they said (N. Engl. J. Med. 2013;369:1295-305).

© MichaelBlackburn/iStockphoto.com

Secondary outcomes, including death or a poor neurodevelopmental outcome among the children at 2 years and problematic incontinence among the mothers at 2 years, will be reported subsequently.

Participants in the Twin Birth Study were women between 32 weeks 0 days gestation and 38 weeks 6 days gestation between Dec. 13, 2003, and April 4, 2011, who were pregnant with twins with an estimated weight of between 1,500 g and 4,000 g each and whose first twin was in the cephalic presentation. The women were randomized to planned cesarean delivery or vaginal delivery with cesarean only if indicated and were followed until 28 days after delivery.

Most (90.7%) in the cesarean delivery group delivered by cesarean as planned, and 43.8% in the planned vaginal delivery group required cesarean delivery, the investigators said

The findings are of note because the twin pregnancy rate has increased over time, largely due to assisted reproductive technologies, and the rate of cesarean section for twins also has increased in the wake of studies suggesting a possible benefit of cesarean delivery with respect to perinatal outcomes.

"There are several possible reasons why our results differ from previous observational data: we avoided selection bias, we ensured the presence of an experienced obstetrician at delivery, and many of the twins in our study were born preterm," the investigators said, adding that no significant interaction between treatment group and baseline variables was seen, which suggests that no significant benefit occurred with planned cesarean delivery for any subgroup tested.

"However, our study was not powered for these subgroup analyses. Further study may be warranted for the gestational-age subgroup of 37 to 38 weeks, particularly given the limited number of infants in this subgroup," they said.

Overall, the results of this study are consistent with no more than a 23% reduction and no more than a 74% increase in the odds of fetal or neonatal death or serious neonatal morbidity with planned cesarean vs. planned vaginal delivery, they said.

"In conclusion, we found no benefits of planned cesarean section, as compared with planned vaginal delivery, for the delivery of twins between 32 and 38 weeks of gestation, if the first twin was in the cephalic presentation," they wrote.

This study was supported by a grant from the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.

No significant differences were seen in the risk of adverse neonatal outcomes between women with twin pregnancy who underwent planned cesarean delivery and those who underwent planned vaginal delivery as part of the randomized Twin Birth Study.

The rate of a composite outcome of fetal or neonatal death or serious neonatal morbidity among 1,393 women in 25 countries assigned to undergo planned cesarean delivery was 2.2%, compared with 1.9% among 1,393 women assigned to planned vaginal delivery (odds ratio with planned cesarean delivery, 1.16), Dr. Jon F.R. Barrett of Sunnybrook Health Sciences Centre, Toronto, and his colleagues reported on behalf of the Twin Birth Study Collaborative Group.

Another outcome – a composite of maternal death or serious maternal morbidity – also did not differ between the groups, occurring in 7.3% of the cesarean group and 8.5% of the vaginal delivery group. This finding, however, may be explained in part by the high rate of cesarean section in the planned vaginal delivery group, they said (N. Engl. J. Med. 2013;369:1295-305).

© MichaelBlackburn/iStockphoto.com

Secondary outcomes, including death or a poor neurodevelopmental outcome among the children at 2 years and problematic incontinence among the mothers at 2 years, will be reported subsequently.

Participants in the Twin Birth Study were women between 32 weeks 0 days gestation and 38 weeks 6 days gestation between Dec. 13, 2003, and April 4, 2011, who were pregnant with twins with an estimated weight of between 1,500 g and 4,000 g each and whose first twin was in the cephalic presentation. The women were randomized to planned cesarean delivery or vaginal delivery with cesarean only if indicated and were followed until 28 days after delivery.

Most (90.7%) in the cesarean delivery group delivered by cesarean as planned, and 43.8% in the planned vaginal delivery group required cesarean delivery, the investigators said

The findings are of note because the twin pregnancy rate has increased over time, largely due to assisted reproductive technologies, and the rate of cesarean section for twins also has increased in the wake of studies suggesting a possible benefit of cesarean delivery with respect to perinatal outcomes.

"There are several possible reasons why our results differ from previous observational data: we avoided selection bias, we ensured the presence of an experienced obstetrician at delivery, and many of the twins in our study were born preterm," the investigators said, adding that no significant interaction between treatment group and baseline variables was seen, which suggests that no significant benefit occurred with planned cesarean delivery for any subgroup tested.

"However, our study was not powered for these subgroup analyses. Further study may be warranted for the gestational-age subgroup of 37 to 38 weeks, particularly given the limited number of infants in this subgroup," they said.

Overall, the results of this study are consistent with no more than a 23% reduction and no more than a 74% increase in the odds of fetal or neonatal death or serious neonatal morbidity with planned cesarean vs. planned vaginal delivery, they said.

"In conclusion, we found no benefits of planned cesarean section, as compared with planned vaginal delivery, for the delivery of twins between 32 and 38 weeks of gestation, if the first twin was in the cephalic presentation," they wrote.

This study was supported by a grant from the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.