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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Respiratory virus season hits health care personnel hard
SAN FRANCISCO – Symptoms of acute respiratory infections occur in 22% of health care providers during the respiratory viral season, and almost as many have asymptomatic infection, according to findings from the Respiratory Protection Effectiveness Clinical Trial.
Mandatory influenza vaccination may help reduce absenteeism resulting from flulike symptoms, according to a separate report from the same study.
The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is an ongoing cluster randomized trial taking place at 99 outpatient departments and emergency departments in seven locations across the United States. The current analyses are based on data collected during 12 weeks of the 2011-12 and 2012-13 respiratory seasons.
For one analysis, 1,686 health care providers were surveyed for signs and symptoms of acute respiratory infection (ARI). Cultures from swabs obtained from those with symptoms, as well as paired blood samples obtained at the start of the intervention and 2 weeks later, revealed that the most common viral isolates were for coronavirus (34%), followed by influenza A and B (32% combined), and rhinovirus (17%), Dr. Trish M. Perl of Johns Hopkins University, Baltimore, reported at an annual scientific meeting on infectious diseases.
Of the 22% of health care providers with ARI symptoms, 28% had identifiable viral causes. Nearly 20% of the providers were asymptomatic but were found to have an identifiable viral infection.
Interestingly, the same three viruses – coronavirus, influenza, and rhinovirus – topped the list of isolates in both symptomatic and asymptomatic patients, Dr. Perl noted.
Also of note, 9 of the 10 patients with influenza in the 2011-12 study period had been vaccinated. The data on influenza among vaccinated individuals were not available for the 2012-13 study period, she said.
At least some of the effect of ARI exposures among providers might be attenuated by a mandatory vaccine program, according to another report from ResPECT.
Of 1,077 health care providers included in that analysis, 64% were from private sites with mandatory vaccine policies and 36% were from Veterans Affairs sites and private sites without a mandatory vaccine policy. Those from sites with mandatory vaccination had significantly higher mean influenza vaccination rates (88% vs. 59%) and a lower mean sick day ratio, defined as symptomatic absenteeism/number of participants (0.56 vs. 0.90), said John Frederick of New York Harbor Healthcare System, New York.
Hand hygiene compliance rates did not differ significantly between the private site and VA site participants (33.1% vs. 33.8%, respectively), and facial protective equipment compliance differed only marginally during respiratory illness exposures (24.7% vs. 19.8%), despite a significantly greater exposure rate among the VA site subjects (11.1% vs. 6.7%), Mr. Frederick noted.
Furthermore, institutional impact of influenza was higher in systems with mandatory vaccine policies and lower sick day ratios.
"So this would suggest that, even in the face of increased influenza rates – an increased burden of disease – increased vaccination rates can actually provide a protective effect to health care personnel, and vaccination rates may very well be the driving differential force," he said.
Though limited by certain factors, such as the use of observational and self-reported data, and possible variability in how participants define ARI symptoms, it still is possible to draw some important conclusions from the findings, he said at the conference, part of 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.
"Mandating vaccination does indeed appear to increase vaccination rates, and increasing vaccination rates does appear to decrease symptomatic absenteeism. So, combining those two, it appears that mandating vaccination does indeed decrease symptomatic absenteeism among health care personnel during viral respiratory season, even in the face of higher influenza rates," he concluded, adding that other factors, such as sick-leave policies, may certainly be in play as well, and that future studies should focus on these.
Dr. Perl and Mr. Frederick reported having no disclosures. The ResPECT trial is supported by Johns Hopkins University, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute for Occupational Safety and Health.
SAN FRANCISCO – Symptoms of acute respiratory infections occur in 22% of health care providers during the respiratory viral season, and almost as many have asymptomatic infection, according to findings from the Respiratory Protection Effectiveness Clinical Trial.
Mandatory influenza vaccination may help reduce absenteeism resulting from flulike symptoms, according to a separate report from the same study.
The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is an ongoing cluster randomized trial taking place at 99 outpatient departments and emergency departments in seven locations across the United States. The current analyses are based on data collected during 12 weeks of the 2011-12 and 2012-13 respiratory seasons.
For one analysis, 1,686 health care providers were surveyed for signs and symptoms of acute respiratory infection (ARI). Cultures from swabs obtained from those with symptoms, as well as paired blood samples obtained at the start of the intervention and 2 weeks later, revealed that the most common viral isolates were for coronavirus (34%), followed by influenza A and B (32% combined), and rhinovirus (17%), Dr. Trish M. Perl of Johns Hopkins University, Baltimore, reported at an annual scientific meeting on infectious diseases.
Of the 22% of health care providers with ARI symptoms, 28% had identifiable viral causes. Nearly 20% of the providers were asymptomatic but were found to have an identifiable viral infection.
Interestingly, the same three viruses – coronavirus, influenza, and rhinovirus – topped the list of isolates in both symptomatic and asymptomatic patients, Dr. Perl noted.
Also of note, 9 of the 10 patients with influenza in the 2011-12 study period had been vaccinated. The data on influenza among vaccinated individuals were not available for the 2012-13 study period, she said.
At least some of the effect of ARI exposures among providers might be attenuated by a mandatory vaccine program, according to another report from ResPECT.
Of 1,077 health care providers included in that analysis, 64% were from private sites with mandatory vaccine policies and 36% were from Veterans Affairs sites and private sites without a mandatory vaccine policy. Those from sites with mandatory vaccination had significantly higher mean influenza vaccination rates (88% vs. 59%) and a lower mean sick day ratio, defined as symptomatic absenteeism/number of participants (0.56 vs. 0.90), said John Frederick of New York Harbor Healthcare System, New York.
Hand hygiene compliance rates did not differ significantly between the private site and VA site participants (33.1% vs. 33.8%, respectively), and facial protective equipment compliance differed only marginally during respiratory illness exposures (24.7% vs. 19.8%), despite a significantly greater exposure rate among the VA site subjects (11.1% vs. 6.7%), Mr. Frederick noted.
Furthermore, institutional impact of influenza was higher in systems with mandatory vaccine policies and lower sick day ratios.
"So this would suggest that, even in the face of increased influenza rates – an increased burden of disease – increased vaccination rates can actually provide a protective effect to health care personnel, and vaccination rates may very well be the driving differential force," he said.
Though limited by certain factors, such as the use of observational and self-reported data, and possible variability in how participants define ARI symptoms, it still is possible to draw some important conclusions from the findings, he said at the conference, part of 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.
"Mandating vaccination does indeed appear to increase vaccination rates, and increasing vaccination rates does appear to decrease symptomatic absenteeism. So, combining those two, it appears that mandating vaccination does indeed decrease symptomatic absenteeism among health care personnel during viral respiratory season, even in the face of higher influenza rates," he concluded, adding that other factors, such as sick-leave policies, may certainly be in play as well, and that future studies should focus on these.
Dr. Perl and Mr. Frederick reported having no disclosures. The ResPECT trial is supported by Johns Hopkins University, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute for Occupational Safety and Health.
SAN FRANCISCO – Symptoms of acute respiratory infections occur in 22% of health care providers during the respiratory viral season, and almost as many have asymptomatic infection, according to findings from the Respiratory Protection Effectiveness Clinical Trial.
Mandatory influenza vaccination may help reduce absenteeism resulting from flulike symptoms, according to a separate report from the same study.
The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is an ongoing cluster randomized trial taking place at 99 outpatient departments and emergency departments in seven locations across the United States. The current analyses are based on data collected during 12 weeks of the 2011-12 and 2012-13 respiratory seasons.
For one analysis, 1,686 health care providers were surveyed for signs and symptoms of acute respiratory infection (ARI). Cultures from swabs obtained from those with symptoms, as well as paired blood samples obtained at the start of the intervention and 2 weeks later, revealed that the most common viral isolates were for coronavirus (34%), followed by influenza A and B (32% combined), and rhinovirus (17%), Dr. Trish M. Perl of Johns Hopkins University, Baltimore, reported at an annual scientific meeting on infectious diseases.
Of the 22% of health care providers with ARI symptoms, 28% had identifiable viral causes. Nearly 20% of the providers were asymptomatic but were found to have an identifiable viral infection.
Interestingly, the same three viruses – coronavirus, influenza, and rhinovirus – topped the list of isolates in both symptomatic and asymptomatic patients, Dr. Perl noted.
Also of note, 9 of the 10 patients with influenza in the 2011-12 study period had been vaccinated. The data on influenza among vaccinated individuals were not available for the 2012-13 study period, she said.
At least some of the effect of ARI exposures among providers might be attenuated by a mandatory vaccine program, according to another report from ResPECT.
Of 1,077 health care providers included in that analysis, 64% were from private sites with mandatory vaccine policies and 36% were from Veterans Affairs sites and private sites without a mandatory vaccine policy. Those from sites with mandatory vaccination had significantly higher mean influenza vaccination rates (88% vs. 59%) and a lower mean sick day ratio, defined as symptomatic absenteeism/number of participants (0.56 vs. 0.90), said John Frederick of New York Harbor Healthcare System, New York.
Hand hygiene compliance rates did not differ significantly between the private site and VA site participants (33.1% vs. 33.8%, respectively), and facial protective equipment compliance differed only marginally during respiratory illness exposures (24.7% vs. 19.8%), despite a significantly greater exposure rate among the VA site subjects (11.1% vs. 6.7%), Mr. Frederick noted.
Furthermore, institutional impact of influenza was higher in systems with mandatory vaccine policies and lower sick day ratios.
"So this would suggest that, even in the face of increased influenza rates – an increased burden of disease – increased vaccination rates can actually provide a protective effect to health care personnel, and vaccination rates may very well be the driving differential force," he said.
Though limited by certain factors, such as the use of observational and self-reported data, and possible variability in how participants define ARI symptoms, it still is possible to draw some important conclusions from the findings, he said at the conference, part of 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.
"Mandating vaccination does indeed appear to increase vaccination rates, and increasing vaccination rates does appear to decrease symptomatic absenteeism. So, combining those two, it appears that mandating vaccination does indeed decrease symptomatic absenteeism among health care personnel during viral respiratory season, even in the face of higher influenza rates," he concluded, adding that other factors, such as sick-leave policies, may certainly be in play as well, and that future studies should focus on these.
Dr. Perl and Mr. Frederick reported having no disclosures. The ResPECT trial is supported by Johns Hopkins University, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute for Occupational Safety and Health.
AT IDWEEK 2013
Major finding: 22% of health care workers developed ARI symptoms and another 19% remained asymptomatic but had verifiable infection during respiratory virus season. Higher flu vaccination rates were associated with fewer sick days.
Data source: A cluster randomized trial involving 1,686 health care providers.
Disclosures: Dr. Perl and Mr. Frederick reported having no disclosures. The ResPECT trial is supported by Johns Hopkins University, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute for Occupational Safety and Health.
Antibiotics are overprescribed for sore throat, bronchitis
SAN FRANCISCO – Physicians continue to inappropriately prescribe antibiotics for sore throat and bronchitis, according to analyses of data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey.
Doctors prescribed antibiotics in 60% of office visits for sore throats and 73% of visits for acute bronchitis. However, the antibiotic prescribing rate should be about 10% for sore throats – based on the prevalence of group A Streptococcus (GAS), the only common cause of sore throat for which antibiotics are indicated – and the rate should be almost zero for acute bronchitis, which is almost always caused by a virus, Dr. Jeffrey A. Linder reported during a press conference at an annual scientific meeting on infectious diseases.
The findings are based on cross-sectional analyses of the nationally representative surveys on visits by adults for either a sore throat or for acute bronchitis. The sore throat findings were based on 8,191 visits between 1997 and 2010.
The overall national antibiotic prescribing rate for sore throats did not change from 1997-1998 to 2009-2010, nor did the prescribing rate among office-based physicians or emergency departments during that time period.
Physicians reported increased prescribing of broad-spectrum, expensive, or nonrecommended antibiotics. However, prescriptions for penicillin – the antibiotic of choice for GAS – remained stable at 9% across the study period.
The bronchitis findings are based on surveys for 3,667 visits by adults with a diagnosis of acute bronchitis to primary care physicians and emergency departments between 1996 and 2010. The overall national antibiotic prescribing rate did not change during the study period, but the prescribing rate in emergency departments increased from 69% in 1996 to 73% in 2010, said Dr. Linder* of Harvard Medical School and Brigham and Women’s Hospital, Boston.
Also, physicians increasingly prescribed extended-spectrum macrolides across the study period, with such prescriptions provided at 25% of visits in 1996 and at 41% of visits in 2010, he noted.
Fluoroquinolones were prescribed at 11% of visits, aminopenicillins were prescribed at 7% of visits, and cephalosporins were prescribed at 7% of visits.
The findings were reported in posters 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. The sore throat findings were also reported concurrently online in the Oct. 4 issue of JAMA Internal Medicine (2013 [doi:10.1001/jamainternmed.2013.11673]).
"The really bad news here is that (the antibiotic prescribing) hasn’t changed at all across the course of the study ... looking back into how we’ve done over past 20 years or so, there’s a little improvement, but it’s painfully slow, and we’re still very far away from the appropriate rate of antibiotic prescribing," he said, noting that this is despite years of effort to promote antibiotic stewardship.
Based on a prior analysis, the antibiotic prescribing rate for sore throat dropped from about 80% to 70% around 1993, and dropped again to 60% by 2000. The current findings show that the prescribing rate remains stable at the 60% level.
Although there was some indication in the survey data that patients are being a little more selective in seeking care for these conditions – perhaps because they are beginning to understand that antibiotics aren’t effective for viral illness – the findings regarding prescribing are troubling, the investigators noted.
Recently, the Centers for Disease Control and Prevention reported that 2 million people are infected with antibiotic-resistant bacteria each year, and 25,000 of those patients die as a result. Antibiotic resistance also causes a great deal of "collateral damage," such as increasing rates of Clostridium difficile infection, said Dr. Ed Septimus, who moderated the press conference.
That results in huge societal costs, estimated at about $35 billion, said Dr. Septimus of Texas A&M Health Science Center, Houston.
Education and improved communication between doctors and patients are needed to address the problem, Dr. Linder and Dr. Septimus agreed.
"Patients and doctors need to have a conversation about the illness ... some of our research suggests that patients don’t want antibiotics as much as doctors think they do," Dr. Septimus said. Doctors often prescribe out of fear that patients will walk away unsatisfied if they don’t get a prescription, he added, but frequently patients just want reassurance that they don’t need an antibiotic.
Accountability is another factor lacking in the outpatient setting, he said.
"We as physicians need to take accountability for our actions ... we need to be reminded that antibiotics, for many of these conditions, are not indicated," he said.
Dr. Linder and Dr. Septimus reported having no disclosures.
*Correction, 10/9/2013: An earlier version of this story misspelled Dr. Linder's name.
SAN FRANCISCO – Physicians continue to inappropriately prescribe antibiotics for sore throat and bronchitis, according to analyses of data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey.
Doctors prescribed antibiotics in 60% of office visits for sore throats and 73% of visits for acute bronchitis. However, the antibiotic prescribing rate should be about 10% for sore throats – based on the prevalence of group A Streptococcus (GAS), the only common cause of sore throat for which antibiotics are indicated – and the rate should be almost zero for acute bronchitis, which is almost always caused by a virus, Dr. Jeffrey A. Linder reported during a press conference at an annual scientific meeting on infectious diseases.
The findings are based on cross-sectional analyses of the nationally representative surveys on visits by adults for either a sore throat or for acute bronchitis. The sore throat findings were based on 8,191 visits between 1997 and 2010.
The overall national antibiotic prescribing rate for sore throats did not change from 1997-1998 to 2009-2010, nor did the prescribing rate among office-based physicians or emergency departments during that time period.
Physicians reported increased prescribing of broad-spectrum, expensive, or nonrecommended antibiotics. However, prescriptions for penicillin – the antibiotic of choice for GAS – remained stable at 9% across the study period.
The bronchitis findings are based on surveys for 3,667 visits by adults with a diagnosis of acute bronchitis to primary care physicians and emergency departments between 1996 and 2010. The overall national antibiotic prescribing rate did not change during the study period, but the prescribing rate in emergency departments increased from 69% in 1996 to 73% in 2010, said Dr. Linder* of Harvard Medical School and Brigham and Women’s Hospital, Boston.
Also, physicians increasingly prescribed extended-spectrum macrolides across the study period, with such prescriptions provided at 25% of visits in 1996 and at 41% of visits in 2010, he noted.
Fluoroquinolones were prescribed at 11% of visits, aminopenicillins were prescribed at 7% of visits, and cephalosporins were prescribed at 7% of visits.
The findings were reported in posters 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. The sore throat findings were also reported concurrently online in the Oct. 4 issue of JAMA Internal Medicine (2013 [doi:10.1001/jamainternmed.2013.11673]).
"The really bad news here is that (the antibiotic prescribing) hasn’t changed at all across the course of the study ... looking back into how we’ve done over past 20 years or so, there’s a little improvement, but it’s painfully slow, and we’re still very far away from the appropriate rate of antibiotic prescribing," he said, noting that this is despite years of effort to promote antibiotic stewardship.
Based on a prior analysis, the antibiotic prescribing rate for sore throat dropped from about 80% to 70% around 1993, and dropped again to 60% by 2000. The current findings show that the prescribing rate remains stable at the 60% level.
Although there was some indication in the survey data that patients are being a little more selective in seeking care for these conditions – perhaps because they are beginning to understand that antibiotics aren’t effective for viral illness – the findings regarding prescribing are troubling, the investigators noted.
Recently, the Centers for Disease Control and Prevention reported that 2 million people are infected with antibiotic-resistant bacteria each year, and 25,000 of those patients die as a result. Antibiotic resistance also causes a great deal of "collateral damage," such as increasing rates of Clostridium difficile infection, said Dr. Ed Septimus, who moderated the press conference.
That results in huge societal costs, estimated at about $35 billion, said Dr. Septimus of Texas A&M Health Science Center, Houston.
Education and improved communication between doctors and patients are needed to address the problem, Dr. Linder and Dr. Septimus agreed.
"Patients and doctors need to have a conversation about the illness ... some of our research suggests that patients don’t want antibiotics as much as doctors think they do," Dr. Septimus said. Doctors often prescribe out of fear that patients will walk away unsatisfied if they don’t get a prescription, he added, but frequently patients just want reassurance that they don’t need an antibiotic.
Accountability is another factor lacking in the outpatient setting, he said.
"We as physicians need to take accountability for our actions ... we need to be reminded that antibiotics, for many of these conditions, are not indicated," he said.
Dr. Linder and Dr. Septimus reported having no disclosures.
*Correction, 10/9/2013: An earlier version of this story misspelled Dr. Linder's name.
SAN FRANCISCO – Physicians continue to inappropriately prescribe antibiotics for sore throat and bronchitis, according to analyses of data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey.
Doctors prescribed antibiotics in 60% of office visits for sore throats and 73% of visits for acute bronchitis. However, the antibiotic prescribing rate should be about 10% for sore throats – based on the prevalence of group A Streptococcus (GAS), the only common cause of sore throat for which antibiotics are indicated – and the rate should be almost zero for acute bronchitis, which is almost always caused by a virus, Dr. Jeffrey A. Linder reported during a press conference at an annual scientific meeting on infectious diseases.
The findings are based on cross-sectional analyses of the nationally representative surveys on visits by adults for either a sore throat or for acute bronchitis. The sore throat findings were based on 8,191 visits between 1997 and 2010.
The overall national antibiotic prescribing rate for sore throats did not change from 1997-1998 to 2009-2010, nor did the prescribing rate among office-based physicians or emergency departments during that time period.
Physicians reported increased prescribing of broad-spectrum, expensive, or nonrecommended antibiotics. However, prescriptions for penicillin – the antibiotic of choice for GAS – remained stable at 9% across the study period.
The bronchitis findings are based on surveys for 3,667 visits by adults with a diagnosis of acute bronchitis to primary care physicians and emergency departments between 1996 and 2010. The overall national antibiotic prescribing rate did not change during the study period, but the prescribing rate in emergency departments increased from 69% in 1996 to 73% in 2010, said Dr. Linder* of Harvard Medical School and Brigham and Women’s Hospital, Boston.
Also, physicians increasingly prescribed extended-spectrum macrolides across the study period, with such prescriptions provided at 25% of visits in 1996 and at 41% of visits in 2010, he noted.
Fluoroquinolones were prescribed at 11% of visits, aminopenicillins were prescribed at 7% of visits, and cephalosporins were prescribed at 7% of visits.
The findings were reported in posters 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. The sore throat findings were also reported concurrently online in the Oct. 4 issue of JAMA Internal Medicine (2013 [doi:10.1001/jamainternmed.2013.11673]).
"The really bad news here is that (the antibiotic prescribing) hasn’t changed at all across the course of the study ... looking back into how we’ve done over past 20 years or so, there’s a little improvement, but it’s painfully slow, and we’re still very far away from the appropriate rate of antibiotic prescribing," he said, noting that this is despite years of effort to promote antibiotic stewardship.
Based on a prior analysis, the antibiotic prescribing rate for sore throat dropped from about 80% to 70% around 1993, and dropped again to 60% by 2000. The current findings show that the prescribing rate remains stable at the 60% level.
Although there was some indication in the survey data that patients are being a little more selective in seeking care for these conditions – perhaps because they are beginning to understand that antibiotics aren’t effective for viral illness – the findings regarding prescribing are troubling, the investigators noted.
Recently, the Centers for Disease Control and Prevention reported that 2 million people are infected with antibiotic-resistant bacteria each year, and 25,000 of those patients die as a result. Antibiotic resistance also causes a great deal of "collateral damage," such as increasing rates of Clostridium difficile infection, said Dr. Ed Septimus, who moderated the press conference.
That results in huge societal costs, estimated at about $35 billion, said Dr. Septimus of Texas A&M Health Science Center, Houston.
Education and improved communication between doctors and patients are needed to address the problem, Dr. Linder and Dr. Septimus agreed.
"Patients and doctors need to have a conversation about the illness ... some of our research suggests that patients don’t want antibiotics as much as doctors think they do," Dr. Septimus said. Doctors often prescribe out of fear that patients will walk away unsatisfied if they don’t get a prescription, he added, but frequently patients just want reassurance that they don’t need an antibiotic.
Accountability is another factor lacking in the outpatient setting, he said.
"We as physicians need to take accountability for our actions ... we need to be reminded that antibiotics, for many of these conditions, are not indicated," he said.
Dr. Linder and Dr. Septimus reported having no disclosures.
*Correction, 10/9/2013: An earlier version of this story misspelled Dr. Linder's name.
AT IDWEEK 2013
Major finding: Doctors prescribed antibiotics in 60% of office visits for sore throats and 73% of visits for acute bronchitis, although the prescribing rate for sore throats should be about 10% and almost zero for acute bronchitis.
Data source: Analyses of survey data representing nearly 12,000 office visits.
Disclosures: Dr. Linder and Dr. Septimus reported having no disclosures.
Investigational Norovirus Vaccine Reduces GI Symptoms
Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.
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.
To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.
Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.
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.
To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.
Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.
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.
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AT IDWEEK 2013
Investigational norovirus vaccine reduces GI symptoms
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.
AT IDWEEK 2013
Major finding: Vaccination reduced vomiting and diarrhea by 52% versus placebo.
Data source: A randomized, double-blind, placebo-controlled study of 109 subjects.
Disclosures: Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte, the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.
Most data reassure regarding TNF inhibitors and cancer
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.
EXPERT ANALYSIS FROM PERSPECTIVES IN RHEUMATIC DISEASES 2013
Universal Glove, Gown Precautions Reduce MRSA Spread
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.
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.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
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"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
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|
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"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
|
|
|
"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
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.
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.
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.
AT IDWEEK 2013
Universal glove, gown precautions reduce MRSA spread
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.
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.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
|
|
|
"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
|
|
|
"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
The findings of Dr. Harris and his colleagues offer a "meaningful addition to a growing cadre of high-quality infection prevention trials," Dr. Preeti N. Malani wrote in an editorial.
However, all of these studies have important limitations, Dr. Malani said.
|
|
|
"The evidence to support infection prevention efforts is a moving target; contact precautions and decolonization strategies are just a few components of an expanding armamentarium. When evaluating these individual interventions, one argument might be that the likelihood of harm (more than clear evidence of benefit) should drive the decision to implement. As such, perhaps it is not the lack of benefit for universal use of gloves and gowns in preventing VRE and MRSA acquisition that is the most noteworthy finding of the study by Harris et al., but rather the suggested lack of harm in using this approach," she wrote, adding that even though the approach failed to demonstrate overall benefit based on the primary endpoint of reducing MRSA and VRE acquisition, universal glove and gown precautions in the ICU may still be worth considering in some instances.
One example is in a surgical ICU setting where MRSA transmission is prevalent, and where a large number of patients have newly implanted medical devices. However, if this approach is used, it should be just part of an overall strategy that also involves hand hygiene optimization and prudent use of antimicrobials, she argued, noting that chlorhexidine gluconate bathing and mupirocin use are also gaining favor.
The relative ease of a given intervention must also be considered, she said.
"Although it is appealing to believe there is a simple approach to what should and should not be done to prevent infection in the ICU, best practices are more nuanced and unfortunately, one size does not fit all," she said.
Dr. Malani is with the University of Michigan Health System, Veterans Affairs Ann Arbor Healthcare System. She made these remarks in an editorial accompanying the study of Dr. Harris (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277816]). Dr. Malani reported having no disclosures.
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.
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.
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.
AT IDWEEK 2013
Major finding: The relative risk reduction for MRSA was 40.2% vs. 15.0% in the intervention vs. control group.
Data source: A cluster randomized trial at 20 ICUs and involving 26,180 patients.
Disclosures: 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.
High-dose flu vaccine immunogenic in frail elderly
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.
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.
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.
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.
AT IDWEEK 2013
Major finding: Geometric mean titers in the standard vs. high-dose group, respectively, for 2011-2012: 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. For 2012-2013: 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
Data source: A randomized single-blind study.
Disclosures: 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
Data provide guidance on herpes zoster vaccination in rheumatoid arthritis
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.
EXPERT ANALYSIS FROM PERSPECTIVES IN RHEUMATIC DISEASES 2013
Data provide guidance on herpes zoster vaccination in rheumatoid arthritis
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.
EXPERT ANALYSIS FROM PERSPECTIVES IN RHEUMATIC DISEASES 2013
