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Generic Biologics' Safety Questioned as Approval Process Stalls
The Biologics Price Competition and Innovation Act, quietly tucked into the health reform bill passed earlier this year, mandated the creation of an abbreviated approval process for follow-on biologic agents similar to the existing pathway for small-molecule drugs.
But 5 months later, the Food and Drug Administration has yet to work out just what that process will entail – and physicians have yet to be reassured that whatever emerges won’t cut corners on safety. And if the safety can be assured, the fruits of such a pathway could be life changing for some patients.
“Tremendously overpriced as they are, the available biologic drugs prevent so much human suffering and disability,” added Dr. Karen Kolba, who is a rheumatologist in solo private practice in Santa Maria, Calif.
“All of my patients would benefit. Those who cannot afford the copays because they are up to 30% of the drug cost would benefit. Those who have private insurance with low copays would benefit because their insurance companies will ultimately be paying out less to drug companies. And those with Medicare or Medicaid will benefit, as will all taxpayers, with lower drug costs.”
The Back Story
Unlike small-molecule generics, which gain approval through an abbreviated new drug application that does not require clinical trials, biologic drugs are vastly more complex – so complex, in fact, that their exact composition is not even known in some cases, according to the Merck Manual.
That is why, in the past, all new biologic drugs for which pharmaceutical companies seek approval in the United States have had to go through a complete new drug application process – including evaluation in animal studies and a full round of human clinical trials – before gaining approval.
The new Biologics Price Competition and Innovation Act (BPCIA) “aligns with the FDA’s long-standing policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing,” according to a statement by the FDA.
And the new law provides guidance on the intellectual property side of the issue. It grants 12 years of patent exclusivity for an original biologic drug, plus a hold on applications for generics until 4 years after the original’s approval. And once approved, the law states, the first generic will itself enjoy a 1-year period of exclusivity.
The Safety Debate
However, the BPCIA does not offer very much guidance on what the abbreviated approval process will entail, said Merrill Matthews, Ph.D., a medical ethicist and a resident scholar with the Institute for Policy Innovation, Lewisville, Tex., a conservative advocacy group that seeks “lower taxes, fewer regulations, and a smaller, less-intrusive government.” He also is the director of the Council for Affordable Health Insurance, a D.C.-based organization promoting free-market health insurance reforms.
The BPCIA “gives the FDA an awful lot of latitude and flexibility in the process of approving biosimilars, and though it requires biosimilars to demonstrate ‘similarity’ with their reference products, approval can be done without clinical trials,” he said at a July 19 press conference on Capitol Hill.
Indeed, the law reads: “An application submitted under this subsection shall include information demonstrating that ... the biological product is biosimilar to a reference product based upon data derived from ... analytical studies that demonstrate that the biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.”
Gordon Johnston, vice president of regulatory science at the Generic Pharmaceutical Association, said he does not find the law to be clear. “The legislation could have been clearer, in our view, in ... defining terms such as ‘highly similar’ and ‘no clinically meaningful difference,’ ” he said in an interview. “For this reason, the process now under way of writing the legislation into regulations is critically important,” he added.
Dr. Kolba also pointed out that the new law would have done well to include at least some requirement that new generic products be entered in a registry to collect safety data. “This would be a much less expensive alternative to years of clinical trials, but ultimately assures us all that they are as safe as the branded products,” she said.?
Dr. Craig Kessler, professor of medicine and pathology at Georgetown University, Washington, agreed. “As a physician, I’m very much in favor of having biosimilars in the marketplace,” he said. “I think we owe it to society to try to reduce the cost of care.”
Nevertheless, “I don’t want to sacrifice patient safety for the decrease in the cost of care, because in the long run, the cost of care will actually be increased if we make the wrong decision.”
Added Rep. Michael C. Burgess (R-Tex.), a physician and also the chairman of the congressional Health Care Caucus, at the July press conference: “Can you really go through an abbreviated process with a drug that is just simply similar to the complex biologic that has already been introduced?
“My concern as a physician, first, always comes back to safety,” he said.
The Next Steps
To resolve these terms, and to figure out a pathway for biogeneric approval, the FDA has formed the Biosimilar Implementation Committee and placed at its head Dr. Janet Woodcock, who is also director of the Center for Drug Evaluation and Research. The new center will hold public meetings to solicit comment from stakeholders, experts, innovators, patients, and the public on some of the concerns surrounding biosimilar approval, according to Dr. Woodcock in a recent press release.
Mr. Johnston said that he expects a meeting to be held sometime by the end of 2010. However, the details remain vague. FDA spokesperson Karen Mahoney could not confirm that any meeting had been scheduled, and would not give any information on when physicians and patients could expect to see the first approvals of generic biologics.
“There are so many factors that will impact when biosimilar products will enter the market,” added Ms. Mahoney. “Therefore,?it is not reasonable to speculate.”
Added Rep. Burgess: “This is a difficult concept, and it does involve a lot of moving parts, and a lot of different contingencies. “For your average member of Congress – or even for your member of Congress with some background in health – it does become difficult to think about these things,” he added.
Dr. Kolba, meanwhile, offered some ideas about how to move forward – without generics.
“If the companies currently manufacturing biologic drugs and selling them at huge profits (having made back their research and development costs years ago) are truly concerned about the potential harm of generic biologics [to their market share,] they can simply decrease their prices to costs plus 10%. This would decrease the overall cost of the drugs by about 65%,” she said.
“At the new prices, generic drug makers will no longer be willing to enter the market, there will be no expensive lawsuits or advertising to pay for, and the 1% of the population with rheumatoid arthritis and other TNF [tumor necrosis factor]-driven diseases will be assured of safe and effective drugs.”
Dr. Kolba disclosed being a past consultant or speaker for the pharmaceutical companies Abbott, Amgen, Bristol-Myers Squibb, Genentech, and UCB. She is currently a principal investigator in clinical trials sponsored by Abbott, Amgen, Lilly, Pfizer, Sanofi-Aventis, and UCB. Dr. Craig Kessler has also disclosed consulting for and receiving research support from pharmaceutical companies including Amgen, Eisai, GlaxoSmithKline, and Sanofi-Aventis.
To view an online version of the July 19 press conference featuring Dr. Kessler, Dr. Matthews, and Congressman Burgess, visit http://health.burgess.house.gov/Blog/?postid=198224.
To view the entire text of the Biologics Price Competition and Innovation Act of 2009, visit www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf.
The Biologics Price Competition and Innovation Act, quietly tucked into the health reform bill passed earlier this year, mandated the creation of an abbreviated approval process for follow-on biologic agents similar to the existing pathway for small-molecule drugs.
But 5 months later, the Food and Drug Administration has yet to work out just what that process will entail – and physicians have yet to be reassured that whatever emerges won’t cut corners on safety. And if the safety can be assured, the fruits of such a pathway could be life changing for some patients.
“Tremendously overpriced as they are, the available biologic drugs prevent so much human suffering and disability,” added Dr. Karen Kolba, who is a rheumatologist in solo private practice in Santa Maria, Calif.
“All of my patients would benefit. Those who cannot afford the copays because they are up to 30% of the drug cost would benefit. Those who have private insurance with low copays would benefit because their insurance companies will ultimately be paying out less to drug companies. And those with Medicare or Medicaid will benefit, as will all taxpayers, with lower drug costs.”
The Back Story
Unlike small-molecule generics, which gain approval through an abbreviated new drug application that does not require clinical trials, biologic drugs are vastly more complex – so complex, in fact, that their exact composition is not even known in some cases, according to the Merck Manual.
That is why, in the past, all new biologic drugs for which pharmaceutical companies seek approval in the United States have had to go through a complete new drug application process – including evaluation in animal studies and a full round of human clinical trials – before gaining approval.
The new Biologics Price Competition and Innovation Act (BPCIA) “aligns with the FDA’s long-standing policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing,” according to a statement by the FDA.
And the new law provides guidance on the intellectual property side of the issue. It grants 12 years of patent exclusivity for an original biologic drug, plus a hold on applications for generics until 4 years after the original’s approval. And once approved, the law states, the first generic will itself enjoy a 1-year period of exclusivity.
The Safety Debate
However, the BPCIA does not offer very much guidance on what the abbreviated approval process will entail, said Merrill Matthews, Ph.D., a medical ethicist and a resident scholar with the Institute for Policy Innovation, Lewisville, Tex., a conservative advocacy group that seeks “lower taxes, fewer regulations, and a smaller, less-intrusive government.” He also is the director of the Council for Affordable Health Insurance, a D.C.-based organization promoting free-market health insurance reforms.
The BPCIA “gives the FDA an awful lot of latitude and flexibility in the process of approving biosimilars, and though it requires biosimilars to demonstrate ‘similarity’ with their reference products, approval can be done without clinical trials,” he said at a July 19 press conference on Capitol Hill.
Indeed, the law reads: “An application submitted under this subsection shall include information demonstrating that ... the biological product is biosimilar to a reference product based upon data derived from ... analytical studies that demonstrate that the biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.”
Gordon Johnston, vice president of regulatory science at the Generic Pharmaceutical Association, said he does not find the law to be clear. “The legislation could have been clearer, in our view, in ... defining terms such as ‘highly similar’ and ‘no clinically meaningful difference,’ ” he said in an interview. “For this reason, the process now under way of writing the legislation into regulations is critically important,” he added.
Dr. Kolba also pointed out that the new law would have done well to include at least some requirement that new generic products be entered in a registry to collect safety data. “This would be a much less expensive alternative to years of clinical trials, but ultimately assures us all that they are as safe as the branded products,” she said.?
Dr. Craig Kessler, professor of medicine and pathology at Georgetown University, Washington, agreed. “As a physician, I’m very much in favor of having biosimilars in the marketplace,” he said. “I think we owe it to society to try to reduce the cost of care.”
Nevertheless, “I don’t want to sacrifice patient safety for the decrease in the cost of care, because in the long run, the cost of care will actually be increased if we make the wrong decision.”
Added Rep. Michael C. Burgess (R-Tex.), a physician and also the chairman of the congressional Health Care Caucus, at the July press conference: “Can you really go through an abbreviated process with a drug that is just simply similar to the complex biologic that has already been introduced?
“My concern as a physician, first, always comes back to safety,” he said.
The Next Steps
To resolve these terms, and to figure out a pathway for biogeneric approval, the FDA has formed the Biosimilar Implementation Committee and placed at its head Dr. Janet Woodcock, who is also director of the Center for Drug Evaluation and Research. The new center will hold public meetings to solicit comment from stakeholders, experts, innovators, patients, and the public on some of the concerns surrounding biosimilar approval, according to Dr. Woodcock in a recent press release.
Mr. Johnston said that he expects a meeting to be held sometime by the end of 2010. However, the details remain vague. FDA spokesperson Karen Mahoney could not confirm that any meeting had been scheduled, and would not give any information on when physicians and patients could expect to see the first approvals of generic biologics.
“There are so many factors that will impact when biosimilar products will enter the market,” added Ms. Mahoney. “Therefore,?it is not reasonable to speculate.”
Added Rep. Burgess: “This is a difficult concept, and it does involve a lot of moving parts, and a lot of different contingencies. “For your average member of Congress – or even for your member of Congress with some background in health – it does become difficult to think about these things,” he added.
Dr. Kolba, meanwhile, offered some ideas about how to move forward – without generics.
“If the companies currently manufacturing biologic drugs and selling them at huge profits (having made back their research and development costs years ago) are truly concerned about the potential harm of generic biologics [to their market share,] they can simply decrease their prices to costs plus 10%. This would decrease the overall cost of the drugs by about 65%,” she said.
“At the new prices, generic drug makers will no longer be willing to enter the market, there will be no expensive lawsuits or advertising to pay for, and the 1% of the population with rheumatoid arthritis and other TNF [tumor necrosis factor]-driven diseases will be assured of safe and effective drugs.”
Dr. Kolba disclosed being a past consultant or speaker for the pharmaceutical companies Abbott, Amgen, Bristol-Myers Squibb, Genentech, and UCB. She is currently a principal investigator in clinical trials sponsored by Abbott, Amgen, Lilly, Pfizer, Sanofi-Aventis, and UCB. Dr. Craig Kessler has also disclosed consulting for and receiving research support from pharmaceutical companies including Amgen, Eisai, GlaxoSmithKline, and Sanofi-Aventis.
To view an online version of the July 19 press conference featuring Dr. Kessler, Dr. Matthews, and Congressman Burgess, visit http://health.burgess.house.gov/Blog/?postid=198224.
To view the entire text of the Biologics Price Competition and Innovation Act of 2009, visit www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf.
The Biologics Price Competition and Innovation Act, quietly tucked into the health reform bill passed earlier this year, mandated the creation of an abbreviated approval process for follow-on biologic agents similar to the existing pathway for small-molecule drugs.
But 5 months later, the Food and Drug Administration has yet to work out just what that process will entail – and physicians have yet to be reassured that whatever emerges won’t cut corners on safety. And if the safety can be assured, the fruits of such a pathway could be life changing for some patients.
“Tremendously overpriced as they are, the available biologic drugs prevent so much human suffering and disability,” added Dr. Karen Kolba, who is a rheumatologist in solo private practice in Santa Maria, Calif.
“All of my patients would benefit. Those who cannot afford the copays because they are up to 30% of the drug cost would benefit. Those who have private insurance with low copays would benefit because their insurance companies will ultimately be paying out less to drug companies. And those with Medicare or Medicaid will benefit, as will all taxpayers, with lower drug costs.”
The Back Story
Unlike small-molecule generics, which gain approval through an abbreviated new drug application that does not require clinical trials, biologic drugs are vastly more complex – so complex, in fact, that their exact composition is not even known in some cases, according to the Merck Manual.
That is why, in the past, all new biologic drugs for which pharmaceutical companies seek approval in the United States have had to go through a complete new drug application process – including evaluation in animal studies and a full round of human clinical trials – before gaining approval.
The new Biologics Price Competition and Innovation Act (BPCIA) “aligns with the FDA’s long-standing policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing,” according to a statement by the FDA.
And the new law provides guidance on the intellectual property side of the issue. It grants 12 years of patent exclusivity for an original biologic drug, plus a hold on applications for generics until 4 years after the original’s approval. And once approved, the law states, the first generic will itself enjoy a 1-year period of exclusivity.
The Safety Debate
However, the BPCIA does not offer very much guidance on what the abbreviated approval process will entail, said Merrill Matthews, Ph.D., a medical ethicist and a resident scholar with the Institute for Policy Innovation, Lewisville, Tex., a conservative advocacy group that seeks “lower taxes, fewer regulations, and a smaller, less-intrusive government.” He also is the director of the Council for Affordable Health Insurance, a D.C.-based organization promoting free-market health insurance reforms.
The BPCIA “gives the FDA an awful lot of latitude and flexibility in the process of approving biosimilars, and though it requires biosimilars to demonstrate ‘similarity’ with their reference products, approval can be done without clinical trials,” he said at a July 19 press conference on Capitol Hill.
Indeed, the law reads: “An application submitted under this subsection shall include information demonstrating that ... the biological product is biosimilar to a reference product based upon data derived from ... analytical studies that demonstrate that the biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.”
Gordon Johnston, vice president of regulatory science at the Generic Pharmaceutical Association, said he does not find the law to be clear. “The legislation could have been clearer, in our view, in ... defining terms such as ‘highly similar’ and ‘no clinically meaningful difference,’ ” he said in an interview. “For this reason, the process now under way of writing the legislation into regulations is critically important,” he added.
Dr. Kolba also pointed out that the new law would have done well to include at least some requirement that new generic products be entered in a registry to collect safety data. “This would be a much less expensive alternative to years of clinical trials, but ultimately assures us all that they are as safe as the branded products,” she said.?
Dr. Craig Kessler, professor of medicine and pathology at Georgetown University, Washington, agreed. “As a physician, I’m very much in favor of having biosimilars in the marketplace,” he said. “I think we owe it to society to try to reduce the cost of care.”
Nevertheless, “I don’t want to sacrifice patient safety for the decrease in the cost of care, because in the long run, the cost of care will actually be increased if we make the wrong decision.”
Added Rep. Michael C. Burgess (R-Tex.), a physician and also the chairman of the congressional Health Care Caucus, at the July press conference: “Can you really go through an abbreviated process with a drug that is just simply similar to the complex biologic that has already been introduced?
“My concern as a physician, first, always comes back to safety,” he said.
The Next Steps
To resolve these terms, and to figure out a pathway for biogeneric approval, the FDA has formed the Biosimilar Implementation Committee and placed at its head Dr. Janet Woodcock, who is also director of the Center for Drug Evaluation and Research. The new center will hold public meetings to solicit comment from stakeholders, experts, innovators, patients, and the public on some of the concerns surrounding biosimilar approval, according to Dr. Woodcock in a recent press release.
Mr. Johnston said that he expects a meeting to be held sometime by the end of 2010. However, the details remain vague. FDA spokesperson Karen Mahoney could not confirm that any meeting had been scheduled, and would not give any information on when physicians and patients could expect to see the first approvals of generic biologics.
“There are so many factors that will impact when biosimilar products will enter the market,” added Ms. Mahoney. “Therefore,?it is not reasonable to speculate.”
Added Rep. Burgess: “This is a difficult concept, and it does involve a lot of moving parts, and a lot of different contingencies. “For your average member of Congress – or even for your member of Congress with some background in health – it does become difficult to think about these things,” he added.
Dr. Kolba, meanwhile, offered some ideas about how to move forward – without generics.
“If the companies currently manufacturing biologic drugs and selling them at huge profits (having made back their research and development costs years ago) are truly concerned about the potential harm of generic biologics [to their market share,] they can simply decrease their prices to costs plus 10%. This would decrease the overall cost of the drugs by about 65%,” she said.
“At the new prices, generic drug makers will no longer be willing to enter the market, there will be no expensive lawsuits or advertising to pay for, and the 1% of the population with rheumatoid arthritis and other TNF [tumor necrosis factor]-driven diseases will be assured of safe and effective drugs.”
Dr. Kolba disclosed being a past consultant or speaker for the pharmaceutical companies Abbott, Amgen, Bristol-Myers Squibb, Genentech, and UCB. She is currently a principal investigator in clinical trials sponsored by Abbott, Amgen, Lilly, Pfizer, Sanofi-Aventis, and UCB. Dr. Craig Kessler has also disclosed consulting for and receiving research support from pharmaceutical companies including Amgen, Eisai, GlaxoSmithKline, and Sanofi-Aventis.
To view an online version of the July 19 press conference featuring Dr. Kessler, Dr. Matthews, and Congressman Burgess, visit http://health.burgess.house.gov/Blog/?postid=198224.
To view the entire text of the Biologics Price Competition and Innovation Act of 2009, visit www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf.
Teen Vaccination Rates Rise, But More Work Needed
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention's MMWR, draws on data from adolescents aged 13–17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
For the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child's provider for vaccination histories. This year's national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018–23).
According to the report's authors led by Dr. Christina Dorell of the CDC's National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine — from 37% to 44% — as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
For chickenpox, in 2009, "75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR)," wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, called the 2009 data "mixed" in an accompanying CDC press release.
"We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group," she said. For example, "Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster."
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention's MMWR, draws on data from adolescents aged 13–17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
For the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child's provider for vaccination histories. This year's national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018–23).
According to the report's authors led by Dr. Christina Dorell of the CDC's National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine — from 37% to 44% — as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
For chickenpox, in 2009, "75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR)," wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, called the 2009 data "mixed" in an accompanying CDC press release.
"We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group," she said. For example, "Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster."
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention's MMWR, draws on data from adolescents aged 13–17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
For the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child's provider for vaccination histories. This year's national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018–23).
According to the report's authors led by Dr. Christina Dorell of the CDC's National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine — from 37% to 44% — as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
For chickenpox, in 2009, "75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR)," wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, called the 2009 data "mixed" in an accompanying CDC press release.
"We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group," she said. For example, "Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster."
Major Finding: Vaccination rates are increased among U.S. teens aged 13–17 years from 2008 to 2009 receiving at least one dose of the Tdap vaccine (from 41% to 56%), the MenACWY (from 42% to 54%), and at least one dose of the HPV vaccine (37% to 44%).
Data Source: The National Immunization Survey for Teens, conducted by the Centers for Disease Control and Prevention.
Disclosures: None was reported.
Non-Light Beer Linked to Psoriasis in Women
Major Finding: Data adjusted for age, smoking, body mass index, dietary folate, and physical exercise showed that women who reported drinking more than 2.3 drinks per week had a 1.72 relative risk of developing psoriasis (95% CI, 1.15-2.57), compared with women to did not drink.
Data Source: A study of more than 82,000 women from the Nurses' Health Study II cohort.
Disclosures: Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer—not wine, liquor, or light beer—that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online Aug. 16 in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women's Hospital, Boston, looked at 116,430 female registered nurses from the Nurses' Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced—2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer's gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies.
VITALS
Source ©Okea/Fotolia.com
Major Finding: Data adjusted for age, smoking, body mass index, dietary folate, and physical exercise showed that women who reported drinking more than 2.3 drinks per week had a 1.72 relative risk of developing psoriasis (95% CI, 1.15-2.57), compared with women to did not drink.
Data Source: A study of more than 82,000 women from the Nurses' Health Study II cohort.
Disclosures: Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer—not wine, liquor, or light beer—that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online Aug. 16 in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women's Hospital, Boston, looked at 116,430 female registered nurses from the Nurses' Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced—2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer's gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies.
VITALS
Source ©Okea/Fotolia.com
Major Finding: Data adjusted for age, smoking, body mass index, dietary folate, and physical exercise showed that women who reported drinking more than 2.3 drinks per week had a 1.72 relative risk of developing psoriasis (95% CI, 1.15-2.57), compared with women to did not drink.
Data Source: A study of more than 82,000 women from the Nurses' Health Study II cohort.
Disclosures: Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer—not wine, liquor, or light beer—that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online Aug. 16 in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women's Hospital, Boston, looked at 116,430 female registered nurses from the Nurses' Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced—2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer's gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies.
VITALS
Source ©Okea/Fotolia.com
Twice-Weekly Tai Chi Eased Fibromyalgia
Major Finding: After 12 weeks of twice-weekly, 60-minute classes, the tai chi group had a significantly greater decrease in the total Fibromyalgia Impact Questionnaire (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls who underwent education about pain management, plus stretching (−9.4 points, 95% CI, −15.5 to −3.4), P less than .001.
Data Source: A single-blind, randomized trial of tai chi compared with wellness education and stretching in fibromyalgia management.
Disclosures: Dr. Wang reported having no financial conflicts of interest. A coauthor reported financial relationships with Pfizer, Lilly, and Forest; several authors reported having received grants from the National Institutes of Health and the National Center for Complementary and Alternative Medicine, which cosponsored the study with the American College of Rheumatology and the Boston Claude D. Pepper Older Americans Independence Center.
Twice-weekly tai chi exercises led to a statistically significant decrease in fibromyalgia symptoms, compared with wellness education and stretching.
The finding, published online in the New England Journal of Medicine, is consistent with other studies that have shown the benefits of tai chi for fibromyalgia as well as pain, depression, and overall quality of life (N. Engl. J. Med. 2010;363:743-54).
Dr. Chenchen Wang, who is with the division of rheumatology at Tufts Medical Center in Boston, and her colleagues looked at patients seen at Dr. Wang's facility between July 2007 and May 2009.
All patients were at least 21 years old and met American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia, including “history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist, with a minimum duration of 3 months, and tenderness on pressure at 11 or more of 18 specific sites,” Dr. Wang and her associates said.
Patients were excluded from the study if they had any tai chi training or serious comorbidities such as rheumatoid arthritis or other conditions that might limit their mobility; if they were pregnant or planning on becoming pregnant; or if they scored less than 24 out of 30 points on the Mini Mental State Examination.
The primary end point was improvement on the Fibromyalgia Impact Questionnaire (FIQ), which scores symptoms on a scale of 1-100, with 100 being the worst.
Thirty patients completed a 12-week, twice-weekly, 60-minute tai chi program, plus a 24-week evaluation. Participants also were encouraged to practice at home for 20 minutes per day on their own, and “to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks,” the investigators wrote.
Meanwhile, 29 control patients completed a twice-weekly, 60-minute wellness education and stretching program, plus the 24-week follow-up.
The program included a didactic portion on pain management strategies and nutrition, plus a portion devoted to stretching. Patients also were encouraged to stretch at home each day for 20-minute periods.
Both groups were predominantly female (greater than 85%) and had mean ages of 50 years and 51 years for the tai chi group and the control group, respectively.
The mean baseline FIQ score in the tai chi group was 62.9, compared with 68.0 in the control group; the rate of attendance was 77% and 70% for the active treatment and control group, respectively.
According to Dr. Wang and her associates, after 12 weeks the patients in the tai chi group had a significantly greater decrease in their total FIQ score, to 35.1 (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls, who fell to 58.6 (−9.4 points, 95% CI, −15.5 to −3.4), for a between-group difference of slightly more than 18 points (P less than .001).
The improvement in symptoms held up at the 24-week mark, with a change from baseline among the tai chi group of −28.6 points from baseline (95% CI, −34.8 to −22.4), compared with −10.2 among controls (95% CI, −16.4 to −4.0).
Similar to findings at the 12-week mark, that amounted to a between-group difference of more than 18 points, P less than .001.
Dr. Wang and her associates also looked at any improvement in sleep, as measured on the Pittsburgh Sleep Quality Index, graded on a scale from 0 to 21, with higher score indicating poorer sleep.
At 12 weeks, the tai chi patients had reduced their score by 3.6 points from baseline, compared with 0.7 points for the control group (P less than .001); at 24 weeks, the tai chi practitioners had dropped their score by 4.2 points, compared with 1.2 among controls (P less than .007).
The researchers also saw significant improvement among the tai chi patients on the physician global assessment score, the patient global assessment score, the 6-minute walk test, and both of the physical and mental components of the Medical Outcomes Study 36-Item Short Form Health Survey.
Only tai chi patients' body mass index and their scores on the Chronic Pain Self Efficacy Scale, which measures patients' confidence in their ability to perform a particular task, did not change significantly in the course of the study, compared with controls.
Dr. Wang and her associates pointed out some limitations, including their inability to conduct a double-blind study, since it “would have required the use of sham tai chi, for which no validated approach currently exists,” though they recommended that one be developed in the future.
Moreover, the investigators stated that the patients' preexisting knowledge and attitudes about tai chi may have resulted in a placebo effect.
To minimize this, they “informed participants only that the study was designed to test the effects of two different types of exercise training programs,” thereby deemphasizing the role of tai chi in order to “lessen participants' expectations.”
The participants also were encouraged to practice at home for 20 minutes per day on their own.
Source ©Willie B. Thomas/iStockphoto.com
MY TAKE
Despite Its Promise, Tai Chi Needs More Study
The findings from the research by Dr. Wang and associates showing that tai chi lessened the severity of fibromyalgia symptoms are provocative and in line with findings from small studies of tai chi in other patient populations.
However, there are other studies that have shown mixed results.
For example, although an 8-week, randomized, controlled study of mindfulness meditation and tai chi–like movements, known as qigong, in 128 patients with fibromyalgia showed significant reductions in pain, disability, and depression, these improvements were no better than those that were seen in the control group, which received educational support (J. Rheumatol. 2003;30:2257-62).
Considering this background, the positive results across all of the outcome measures that were reported by Dr. Wang and her associates are striking.
Nevertheless, questions remain: How much of the benefit of tai chi is due to a placebo effect? What is an appropriate control for tai chi? And what do these findings mean for clinical practice?
Going forward, replications of this study on a larger scale over longer periods of time are needed, with different practitioners and different styles at multiple sites, as well as determination of the optimal “dose” of tai chi.
Additionally, research should focus on comparisons with similar therapies such as yoga, plus an assessment of cost-effectiveness.
Even so, the potential efficacy and lack of adverse effects now make it reasonable for physicians to support patients' interest in exploring these types of exercises, even if it is too early to take out a prescription pad and write “tai chi.”
Dr. Yeh's remarks are paraphrased from her editorial, which accompanied the research report by Dr. Wang and associates (N. Engl. J. Med. 2010;363:783-4).
GLORIA Y. YEH, M.D., is in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, Boston, as well as the division of general medicine and primary care at Beth Israel Deaconess Medical Center, Boston. She cowrote the editorial with Ted J. Kaptchuk, also of Harvard and the division of general medicine and primary care at Beth Israel, and Dr. Robert H. Shmerling, who is with the division of rheumatology at Beth Israel. The investigators were not involved with this study and stated they had no disclosures relative to their editorial.
Major Finding: After 12 weeks of twice-weekly, 60-minute classes, the tai chi group had a significantly greater decrease in the total Fibromyalgia Impact Questionnaire (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls who underwent education about pain management, plus stretching (−9.4 points, 95% CI, −15.5 to −3.4), P less than .001.
Data Source: A single-blind, randomized trial of tai chi compared with wellness education and stretching in fibromyalgia management.
Disclosures: Dr. Wang reported having no financial conflicts of interest. A coauthor reported financial relationships with Pfizer, Lilly, and Forest; several authors reported having received grants from the National Institutes of Health and the National Center for Complementary and Alternative Medicine, which cosponsored the study with the American College of Rheumatology and the Boston Claude D. Pepper Older Americans Independence Center.
Twice-weekly tai chi exercises led to a statistically significant decrease in fibromyalgia symptoms, compared with wellness education and stretching.
The finding, published online in the New England Journal of Medicine, is consistent with other studies that have shown the benefits of tai chi for fibromyalgia as well as pain, depression, and overall quality of life (N. Engl. J. Med. 2010;363:743-54).
Dr. Chenchen Wang, who is with the division of rheumatology at Tufts Medical Center in Boston, and her colleagues looked at patients seen at Dr. Wang's facility between July 2007 and May 2009.
All patients were at least 21 years old and met American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia, including “history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist, with a minimum duration of 3 months, and tenderness on pressure at 11 or more of 18 specific sites,” Dr. Wang and her associates said.
Patients were excluded from the study if they had any tai chi training or serious comorbidities such as rheumatoid arthritis or other conditions that might limit their mobility; if they were pregnant or planning on becoming pregnant; or if they scored less than 24 out of 30 points on the Mini Mental State Examination.
The primary end point was improvement on the Fibromyalgia Impact Questionnaire (FIQ), which scores symptoms on a scale of 1-100, with 100 being the worst.
Thirty patients completed a 12-week, twice-weekly, 60-minute tai chi program, plus a 24-week evaluation. Participants also were encouraged to practice at home for 20 minutes per day on their own, and “to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks,” the investigators wrote.
Meanwhile, 29 control patients completed a twice-weekly, 60-minute wellness education and stretching program, plus the 24-week follow-up.
The program included a didactic portion on pain management strategies and nutrition, plus a portion devoted to stretching. Patients also were encouraged to stretch at home each day for 20-minute periods.
Both groups were predominantly female (greater than 85%) and had mean ages of 50 years and 51 years for the tai chi group and the control group, respectively.
The mean baseline FIQ score in the tai chi group was 62.9, compared with 68.0 in the control group; the rate of attendance was 77% and 70% for the active treatment and control group, respectively.
According to Dr. Wang and her associates, after 12 weeks the patients in the tai chi group had a significantly greater decrease in their total FIQ score, to 35.1 (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls, who fell to 58.6 (−9.4 points, 95% CI, −15.5 to −3.4), for a between-group difference of slightly more than 18 points (P less than .001).
The improvement in symptoms held up at the 24-week mark, with a change from baseline among the tai chi group of −28.6 points from baseline (95% CI, −34.8 to −22.4), compared with −10.2 among controls (95% CI, −16.4 to −4.0).
Similar to findings at the 12-week mark, that amounted to a between-group difference of more than 18 points, P less than .001.
Dr. Wang and her associates also looked at any improvement in sleep, as measured on the Pittsburgh Sleep Quality Index, graded on a scale from 0 to 21, with higher score indicating poorer sleep.
At 12 weeks, the tai chi patients had reduced their score by 3.6 points from baseline, compared with 0.7 points for the control group (P less than .001); at 24 weeks, the tai chi practitioners had dropped their score by 4.2 points, compared with 1.2 among controls (P less than .007).
The researchers also saw significant improvement among the tai chi patients on the physician global assessment score, the patient global assessment score, the 6-minute walk test, and both of the physical and mental components of the Medical Outcomes Study 36-Item Short Form Health Survey.
Only tai chi patients' body mass index and their scores on the Chronic Pain Self Efficacy Scale, which measures patients' confidence in their ability to perform a particular task, did not change significantly in the course of the study, compared with controls.
Dr. Wang and her associates pointed out some limitations, including their inability to conduct a double-blind study, since it “would have required the use of sham tai chi, for which no validated approach currently exists,” though they recommended that one be developed in the future.
Moreover, the investigators stated that the patients' preexisting knowledge and attitudes about tai chi may have resulted in a placebo effect.
To minimize this, they “informed participants only that the study was designed to test the effects of two different types of exercise training programs,” thereby deemphasizing the role of tai chi in order to “lessen participants' expectations.”
The participants also were encouraged to practice at home for 20 minutes per day on their own.
Source ©Willie B. Thomas/iStockphoto.com
MY TAKE
Despite Its Promise, Tai Chi Needs More Study
The findings from the research by Dr. Wang and associates showing that tai chi lessened the severity of fibromyalgia symptoms are provocative and in line with findings from small studies of tai chi in other patient populations.
However, there are other studies that have shown mixed results.
For example, although an 8-week, randomized, controlled study of mindfulness meditation and tai chi–like movements, known as qigong, in 128 patients with fibromyalgia showed significant reductions in pain, disability, and depression, these improvements were no better than those that were seen in the control group, which received educational support (J. Rheumatol. 2003;30:2257-62).
Considering this background, the positive results across all of the outcome measures that were reported by Dr. Wang and her associates are striking.
Nevertheless, questions remain: How much of the benefit of tai chi is due to a placebo effect? What is an appropriate control for tai chi? And what do these findings mean for clinical practice?
Going forward, replications of this study on a larger scale over longer periods of time are needed, with different practitioners and different styles at multiple sites, as well as determination of the optimal “dose” of tai chi.
Additionally, research should focus on comparisons with similar therapies such as yoga, plus an assessment of cost-effectiveness.
Even so, the potential efficacy and lack of adverse effects now make it reasonable for physicians to support patients' interest in exploring these types of exercises, even if it is too early to take out a prescription pad and write “tai chi.”
Dr. Yeh's remarks are paraphrased from her editorial, which accompanied the research report by Dr. Wang and associates (N. Engl. J. Med. 2010;363:783-4).
GLORIA Y. YEH, M.D., is in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, Boston, as well as the division of general medicine and primary care at Beth Israel Deaconess Medical Center, Boston. She cowrote the editorial with Ted J. Kaptchuk, also of Harvard and the division of general medicine and primary care at Beth Israel, and Dr. Robert H. Shmerling, who is with the division of rheumatology at Beth Israel. The investigators were not involved with this study and stated they had no disclosures relative to their editorial.
Major Finding: After 12 weeks of twice-weekly, 60-minute classes, the tai chi group had a significantly greater decrease in the total Fibromyalgia Impact Questionnaire (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls who underwent education about pain management, plus stretching (−9.4 points, 95% CI, −15.5 to −3.4), P less than .001.
Data Source: A single-blind, randomized trial of tai chi compared with wellness education and stretching in fibromyalgia management.
Disclosures: Dr. Wang reported having no financial conflicts of interest. A coauthor reported financial relationships with Pfizer, Lilly, and Forest; several authors reported having received grants from the National Institutes of Health and the National Center for Complementary and Alternative Medicine, which cosponsored the study with the American College of Rheumatology and the Boston Claude D. Pepper Older Americans Independence Center.
Twice-weekly tai chi exercises led to a statistically significant decrease in fibromyalgia symptoms, compared with wellness education and stretching.
The finding, published online in the New England Journal of Medicine, is consistent with other studies that have shown the benefits of tai chi for fibromyalgia as well as pain, depression, and overall quality of life (N. Engl. J. Med. 2010;363:743-54).
Dr. Chenchen Wang, who is with the division of rheumatology at Tufts Medical Center in Boston, and her colleagues looked at patients seen at Dr. Wang's facility between July 2007 and May 2009.
All patients were at least 21 years old and met American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia, including “history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist, with a minimum duration of 3 months, and tenderness on pressure at 11 or more of 18 specific sites,” Dr. Wang and her associates said.
Patients were excluded from the study if they had any tai chi training or serious comorbidities such as rheumatoid arthritis or other conditions that might limit their mobility; if they were pregnant or planning on becoming pregnant; or if they scored less than 24 out of 30 points on the Mini Mental State Examination.
The primary end point was improvement on the Fibromyalgia Impact Questionnaire (FIQ), which scores symptoms on a scale of 1-100, with 100 being the worst.
Thirty patients completed a 12-week, twice-weekly, 60-minute tai chi program, plus a 24-week evaluation. Participants also were encouraged to practice at home for 20 minutes per day on their own, and “to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks,” the investigators wrote.
Meanwhile, 29 control patients completed a twice-weekly, 60-minute wellness education and stretching program, plus the 24-week follow-up.
The program included a didactic portion on pain management strategies and nutrition, plus a portion devoted to stretching. Patients also were encouraged to stretch at home each day for 20-minute periods.
Both groups were predominantly female (greater than 85%) and had mean ages of 50 years and 51 years for the tai chi group and the control group, respectively.
The mean baseline FIQ score in the tai chi group was 62.9, compared with 68.0 in the control group; the rate of attendance was 77% and 70% for the active treatment and control group, respectively.
According to Dr. Wang and her associates, after 12 weeks the patients in the tai chi group had a significantly greater decrease in their total FIQ score, to 35.1 (−27.8 points, 95% confidence interval −33.8 to −21.8) compared with controls, who fell to 58.6 (−9.4 points, 95% CI, −15.5 to −3.4), for a between-group difference of slightly more than 18 points (P less than .001).
The improvement in symptoms held up at the 24-week mark, with a change from baseline among the tai chi group of −28.6 points from baseline (95% CI, −34.8 to −22.4), compared with −10.2 among controls (95% CI, −16.4 to −4.0).
Similar to findings at the 12-week mark, that amounted to a between-group difference of more than 18 points, P less than .001.
Dr. Wang and her associates also looked at any improvement in sleep, as measured on the Pittsburgh Sleep Quality Index, graded on a scale from 0 to 21, with higher score indicating poorer sleep.
At 12 weeks, the tai chi patients had reduced their score by 3.6 points from baseline, compared with 0.7 points for the control group (P less than .001); at 24 weeks, the tai chi practitioners had dropped their score by 4.2 points, compared with 1.2 among controls (P less than .007).
The researchers also saw significant improvement among the tai chi patients on the physician global assessment score, the patient global assessment score, the 6-minute walk test, and both of the physical and mental components of the Medical Outcomes Study 36-Item Short Form Health Survey.
Only tai chi patients' body mass index and their scores on the Chronic Pain Self Efficacy Scale, which measures patients' confidence in their ability to perform a particular task, did not change significantly in the course of the study, compared with controls.
Dr. Wang and her associates pointed out some limitations, including their inability to conduct a double-blind study, since it “would have required the use of sham tai chi, for which no validated approach currently exists,” though they recommended that one be developed in the future.
Moreover, the investigators stated that the patients' preexisting knowledge and attitudes about tai chi may have resulted in a placebo effect.
To minimize this, they “informed participants only that the study was designed to test the effects of two different types of exercise training programs,” thereby deemphasizing the role of tai chi in order to “lessen participants' expectations.”
The participants also were encouraged to practice at home for 20 minutes per day on their own.
Source ©Willie B. Thomas/iStockphoto.com
MY TAKE
Despite Its Promise, Tai Chi Needs More Study
The findings from the research by Dr. Wang and associates showing that tai chi lessened the severity of fibromyalgia symptoms are provocative and in line with findings from small studies of tai chi in other patient populations.
However, there are other studies that have shown mixed results.
For example, although an 8-week, randomized, controlled study of mindfulness meditation and tai chi–like movements, known as qigong, in 128 patients with fibromyalgia showed significant reductions in pain, disability, and depression, these improvements were no better than those that were seen in the control group, which received educational support (J. Rheumatol. 2003;30:2257-62).
Considering this background, the positive results across all of the outcome measures that were reported by Dr. Wang and her associates are striking.
Nevertheless, questions remain: How much of the benefit of tai chi is due to a placebo effect? What is an appropriate control for tai chi? And what do these findings mean for clinical practice?
Going forward, replications of this study on a larger scale over longer periods of time are needed, with different practitioners and different styles at multiple sites, as well as determination of the optimal “dose” of tai chi.
Additionally, research should focus on comparisons with similar therapies such as yoga, plus an assessment of cost-effectiveness.
Even so, the potential efficacy and lack of adverse effects now make it reasonable for physicians to support patients' interest in exploring these types of exercises, even if it is too early to take out a prescription pad and write “tai chi.”
Dr. Yeh's remarks are paraphrased from her editorial, which accompanied the research report by Dr. Wang and associates (N. Engl. J. Med. 2010;363:783-4).
GLORIA Y. YEH, M.D., is in the division for research and education in complementary and integrative medical therapies at Harvard Medical School, Boston, as well as the division of general medicine and primary care at Beth Israel Deaconess Medical Center, Boston. She cowrote the editorial with Ted J. Kaptchuk, also of Harvard and the division of general medicine and primary care at Beth Israel, and Dr. Robert H. Shmerling, who is with the division of rheumatology at Beth Israel. The investigators were not involved with this study and stated they had no disclosures relative to their editorial.
New RA Guidelines Emphasize Early Treatment
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a "new paradigm" that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR's Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to "to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis," wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an "agreed-upon list of standardized clinical and laboratory variables collected at baseline."
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an "expert panel" of 12 rheumatologists related the above clinical and laboratory factors to the "probability of developing 'persistent inflammatory and/or erosive arthritis that is currently considered to be RA.'?"
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II "to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA."
This final scale assigns points in the following manner:
– One swollen "large joint" (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 "small" joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a "low-positive" RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A "high-positive" of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as "definite RA."
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, "A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis."
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, "Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement."
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
"When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy," he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments.
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a "new paradigm" that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR's Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to "to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis," wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an "agreed-upon list of standardized clinical and laboratory variables collected at baseline."
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an "expert panel" of 12 rheumatologists related the above clinical and laboratory factors to the "probability of developing 'persistent inflammatory and/or erosive arthritis that is currently considered to be RA.'?"
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II "to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA."
This final scale assigns points in the following manner:
– One swollen "large joint" (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 "small" joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a "low-positive" RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A "high-positive" of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as "definite RA."
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, "A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis."
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, "Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement."
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
"When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy," he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments.
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a "new paradigm" that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR's Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to "to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis," wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an "agreed-upon list of standardized clinical and laboratory variables collected at baseline."
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an "expert panel" of 12 rheumatologists related the above clinical and laboratory factors to the "probability of developing 'persistent inflammatory and/or erosive arthritis that is currently considered to be RA.'?"
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II "to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA."
This final scale assigns points in the following manner:
– One swollen "large joint" (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 "small" joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a "low-positive" RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A "high-positive" of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as "definite RA."
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, "A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis."
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, "Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement."
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
"When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy," he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments.
Major Finding: A new criteria set for rheumatoid arthritis identifies early disease based on a score of 6 or higher out of 10.
Data Source: An international committee of rheumatologists from both the European League Against Rheumatism and the American College of Rheumatology.
Disclosures: Several of the authors of the guidelines disclosed financial relationships with multiple drug makers.
New RA Guidelines Emphasize Early Identification, Treatment
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a “new paradigm” that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR’s Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to “to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis,” wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an “agreed-upon list of standardized clinical and laboratory variables collected at baseline.”
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an “expert panel” of 12 rheumatologists related the above clinical and laboratory factors to the “probability of developing ‘persistent inflammatory and/or erosive arthritis that is currently considered to be RA.’?”
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II “to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA.”
This final scale assigns points in the following manner:
– One swollen “large joint” (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 “small” joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a “low-positive” RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A “high-positive” of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as “definite RA.”
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, “A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis.”
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, “Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement.”
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
“When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy,” he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments. Dr. Cohen and Dr. Emery stated that they had no competing interests to disclose in relation to their editorial.
Dr. Paul Emery |
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
Dr. Paul Emery |
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
Dr. Paul Emery |
In an editorial accompanying the guidelines in the Annals of the Rheumatic Diseases, ACR President Stanley Cohen and EULAR President Paul Emery said that the 1987 criteria, although useful for differentiating “established” RA from other rheumatologic diseases, are “widely regarded as unsatisfactory for the diagnosis of RA (for which they were not designed)” (Ann. Rheum. Dis. 2010;69:1575-6).
However, in 2010, “the need for the new classification criteria has been made more urgent by the understanding that, at presentation, RA may be an evolving disease, the final phenotype of which can be altered by interventions.”
And despite the fact that “change can be difficult for a generation of rheumatologists used to classifying RA with the old criteria,” the authors were hopeful that “these new classification criteria will be rapidly adopted in daily practice, and we look forward to their implementation in clinical trials.”
Indeed, they added, “How these criteria might impact patient selection for clinical trials will be of great interest.”
Dr. Cohen is affiliated with the clinical research center at the University of Texas Southwestern Medical School in Dallas. Dr. Emery is from the University of Leeds (England). Both stated that they had no competing interests to disclose in relation to this editorial.
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a “new paradigm” that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR’s Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to “to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis,” wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an “agreed-upon list of standardized clinical and laboratory variables collected at baseline.”
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an “expert panel” of 12 rheumatologists related the above clinical and laboratory factors to the “probability of developing ‘persistent inflammatory and/or erosive arthritis that is currently considered to be RA.’?”
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II “to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA.”
This final scale assigns points in the following manner:
– One swollen “large joint” (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 “small” joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a “low-positive” RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A “high-positive” of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as “definite RA.”
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, “A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis.”
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, “Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement.”
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
“When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy,” he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments. Dr. Cohen and Dr. Emery stated that they had no competing interests to disclose in relation to their editorial.
The promised overhaul of treatment guidelines for rheumatoid arthritis has finally arrived, and with it, a “new paradigm” that focuses on early identification and treatment of the disabling disease.
The guidelines, which were developed by a joint committee from the American College of Rheumatology and the European League Against Rheumatism, are the latest update since the current guidelines were created in 1987.
Published jointly in the EULAR journal Annals of the Rheumatic Diseases (2010;69:1580-8) and the ACR’s Arthritis and Rheumatism (2010;62:2569-81), the new guidelines were created in three phases over 2 years.
In the first phase, the goal was to “to identify the contributions of clinical and laboratory variables that in practice were the most predictive of the decision to initiate [disease-modifying antirheumatic drug] therapy in a population of patients with early undifferentiated synovitis,” wrote the authors, led by Dr. Daniel Aletaha of the Medical University of Vienna.
To do this, a working group from both societies looked at data from 3,115 patients, and correlated whether or not the patients were ultimately prescribed methotrexate to an “agreed-upon list of standardized clinical and laboratory variables collected at baseline.”
The odds of eventual methotrexate initiation were calculated for each variable. For example, swelling of the metacarpophalangeal joint had an odds ratio of 1.5, as did swelling of the proximal interphalangeal joint and the wrist. Tenderness of the hand (either the MCP, PIP, or wrist) was assigned an odds ratio of 2.0.
A moderate elevation of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) was assigned an OR of 1.0; a high elevation of either assay carried an OR of 2.0.
Finally, moderate levels of either rheumatoid factor or anti–citrullinated protein antibodies had an OR of 2.0 for the eventual prescription of a DMARD; high levels had an OR of 4.0.
In phase II, an “expert panel” of 12 rheumatologists related the above clinical and laboratory factors to the “probability of developing ‘persistent inflammatory and/or erosive arthritis that is currently considered to be RA.’?”
The panel also looked at duration of symptoms (longer or shorter than 6 weeks) and the number and size of joints (large or small), in addition to the variables that were assessed in phase I. Using a computer program, the panel assigned each variable a point value of 1-100, with high scores indicating greater likelihood of RA.
Finally, phase III aimed to utilize the results of phases I and II “to develop a scoring system that would be applicable to newly presenting patients with undifferentiated inflammatory arthritis, to permit identification of those with a high probability of developing persistent and/or erosive RA.”
This final scale assigns points in the following manner:
– One swollen “large joint” (defined as shoulders, elbows, hips, knees, and ankles) gets 0 points; involvement of 2-10 large joints gets 1 point.
– Involvement of 1-3 “small” joints (defined as metacarpophalangeal joints, proximal interphalangeal joints, second to fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) gets 2 points, regardless of large-joint involvement; involvement of 4-10 small joints gets 3 points.
– Involvement of more than 10 joints, including at least one small joint, gets 5 points.
– Both a negative rheumatoid factor (RF) test and a negative anti–citrullinated protein antibody test (ACPA) gets 0 points, whereas having a “low-positive” RF or ACPA (defined as lower than three times the upper limit of normal) gets 2 points. A “high-positive” of either test gets 3 points.
– A normal CRP and normal ESR get 0 points, whereas at least one abnormal test gets 1 point.
– Symptom duration of fewer than 6 weeks gets 0 points; duration of 6 weeks or longer gets 1 point.
Scores of 6 or more out of 10 are classified as “definite RA.”
Commenting on the new criteria in an interview, Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic in Rochester, Minn., and was not involved in the study, said, “A major useful feature is that the new guidelines do not require multiple joints to be inflamed before a diagnosis can be [made] of early inflammatory rheumatoid arthritis.”
Indeed, a patient may score 6 points without multiple joint inflammation, according to the new guidelines.
The authors also pointed out that symmetry is not a criterion for diagnosis, as it did not show significance in either phase of the new guidelines’ development. Nevertheless, they wrote, “Inevitably ... the greater the number of involved joints the higher the likelihood of bilateral involvement.”
When Dr. Matteson was asked what was missing from the new guidelines, he pointed to a lack of awareness of extra-articular components of RA, which also can occur early in the course of the disease.
“When they do [occur], they can be very useful in identifying the disease, and they are important markers and predictors of disease severity and need for therapy,” he said.
The guidelines also lack biomarkers for treatment response, he added.
Several of the guideline authors disclosed financial and other relationships with multiple pharmaceutical companies. Dr. Matteson stated that he had no financial disclosures relative to his comments. Dr. Cohen and Dr. Emery stated that they had no competing interests to disclose in relation to their editorial.
Major Finding: A new criteria set for rheumatoid arthritis identifies early disease based on a score of 6 or higher out of 10.
Data Source: An international committee of rheumatologists from both the European League Against Rheumatism and the American College of Rheumatology.
Disclosures: Several of the authors of the guidelines disclosed financial relationships with multiple drug makers.
Dark Beer Ups Psoriasis Risk in Women
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer – not wine, liquor, or light beer – that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women’s Hospital, Boston, looked at 116,430 female registered nurses from the Nurses’ Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced – 2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer’s gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies, and beer is one of the few nondistilled alcoholic beverages to use a starch source for fermentation – barley, most commonly. However, light beer also is made with grain and therefore contains gluten, albeit lower amounts.
One major limitation of the study, according to Dr. Qureshi, is the retrospective recall of psoriasis onset, which might have led to misclassification of some psoriasis incidents. Additionally, the researchers wrote, “This well-educated female cohort provides high-quality data with little loss to follow-up but does not represent a random sample of U.S. women,” nor of alcohol consumption rates.
Nevertheless, they added, “the biological effects of alcohol intake on psoriasis should be similar.”
Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer – not wine, liquor, or light beer – that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women’s Hospital, Boston, looked at 116,430 female registered nurses from the Nurses’ Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced – 2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer’s gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies, and beer is one of the few nondistilled alcoholic beverages to use a starch source for fermentation – barley, most commonly. However, light beer also is made with grain and therefore contains gluten, albeit lower amounts.
One major limitation of the study, according to Dr. Qureshi, is the retrospective recall of psoriasis onset, which might have led to misclassification of some psoriasis incidents. Additionally, the researchers wrote, “This well-educated female cohort provides high-quality data with little loss to follow-up but does not represent a random sample of U.S. women,” nor of alcohol consumption rates.
Nevertheless, they added, “the biological effects of alcohol intake on psoriasis should be similar.”
Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Women who drink more than two drinks per week are significantly more likely to develop psoriasis than are women who abstain from alcohol.
Moreover, when stratified by type of alcohol consumed, it is full-calorie, non-light beer – not wine, liquor, or light beer – that appears to raise the risk for the skin condition, according to a study of over 82,000 women published online in the Archives of Dermatology.
Dr. Abrar A. Qureshi, director of the Translational Research Resource Center in the department of dermatology at Brigham and Women’s Hospital, Boston, looked at 116,430 female registered nurses from the Nurses’ Health Study II (an ongoing longitudinal study begun in 1989).
The nurses were asked about whether they had ever had a diagnosis of psoriasis between 1991 and 2005, with 1991 being the first year in the study in which alcohol intake data patterns were assessed. Weekly drinking was also assessed in 1995, 1999, and 2003 (doi:10.1001/archdermatol.2010.204).
Overall, among the 47,614 women who responded to the survey and reported consuming alcohol, the mean age was 36 years. It was the same for the 35,058 abstainers who responded.
The only differences between the cohorts were that the abstainers had a slightly higher body mass index (BMI) and were less physically active; drinkers were more likely to smoke or have ever smoked.
Dr. Qureshi and his colleagues found that with adjustment for age only, there was a 1.89 relative risk of developing psoriasis among patients who reported drinking more than 2.3 drinks per week (95% confidence interval, 1.29-2.77).
When adjusted for age, smoking, BMI, dietary folate, and physical exercise, the risk dropped, but only slightly, to 1.72 (95% CI, 1.15-2.57).
Furthermore, when stratified by type of alcohol, having five or more glasses of non-light beer per week was the only beverage to be significantly associated with incident psoriasis, after the multivariate adjustment (RR 1.76; 95% CI 1.15-2.69). Five or more glasses of light beer, white wine, or red wine were not significantly associated with psoriasis, nor were two or more glasses per week of liquor.
Finally, the authors analyzed alcohol intake and confirmed psoriasis according to the Psoriasis Screening Tool questionnaire, a one-page, self-administered, seven-question survey sent to all study participants who reported prior psoriasis diagnosis.
Among this subgroup of confirmed cases, after the same multivariate adjustment used in the earlier analysis, the relative risk associated with any alcohol intake above 2.3 drinks per week was even more pronounced – 2.54 (95% CI, 1.57-4.10), and for 5 or more non-light beer drinks per week, it was 2.29 (95% CI, 1.36-3.85).
The authors postulated that beer’s gluten content could be the culprit, since gluten has been tied to psoriasis in prior studies, and beer is one of the few nondistilled alcoholic beverages to use a starch source for fermentation – barley, most commonly. However, light beer also is made with grain and therefore contains gluten, albeit lower amounts.
One major limitation of the study, according to Dr. Qureshi, is the retrospective recall of psoriasis onset, which might have led to misclassification of some psoriasis incidents. Additionally, the researchers wrote, “This well-educated female cohort provides high-quality data with little loss to follow-up but does not represent a random sample of U.S. women,” nor of alcohol consumption rates.
Nevertheless, they added, “the biological effects of alcohol intake on psoriasis should be similar.”
Dr. Qureshi disclosed serving as a consultant to pharmaceutical makers Amgen and Genentech; the study was funded by grants from the National Institutes of Health/National Cancer Institute.
Teen Vaccination Rates on the Rise, but More Work Is Needed
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention’s MMWR, draws on data from adolescents aged 13-17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
To gather the data for the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child’s provider for vaccination histories. This year’s national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018-23).
According to the report’s authors led by Dr. Christina Dorell of the CDC’s National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine – from 37% to 44% – as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
Looking at chickenpox, in 2009, “75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR),” wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, called the 2009 data “mixed” in an accompanying CDC press release. A complete breakdown of vaccination rates by state and nationally, going back to 2006, is available at the CDC.
“We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system’s ability to reach this age group,” she said. For example, “Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster.”
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention’s MMWR, draws on data from adolescents aged 13-17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
To gather the data for the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child’s provider for vaccination histories. This year’s national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018-23).
According to the report’s authors led by Dr. Christina Dorell of the CDC’s National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine – from 37% to 44% – as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
Looking at chickenpox, in 2009, “75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR),” wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, called the 2009 data “mixed” in an accompanying CDC press release. A complete breakdown of vaccination rates by state and nationally, going back to 2006, is available at the CDC.
“We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system’s ability to reach this age group,” she said. For example, “Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster.”
Vaccination coverage among U.S. teens increased nationally by as much as 15% in 2009, compared with 2008, but there is still room for improvement.
The finding, released Aug. 19 from the Centers for Disease Control and Prevention’s MMWR, draws on data from adolescents aged 13-17 years who participated in the National Immunization Survey for Teens, which has been conducted every year since 2006.
To gather the data for the survey, parents of teens were contacted randomly by telephone and were asked for permission to contact the child’s provider for vaccination histories. This year’s national survey included 20,066 individual records from all 50 states, plus the U.S. Virgin Islands (MMWR 2010;59:1018-23).
According to the report’s authors led by Dr. Christina Dorell of the CDC’s National Center for Immunization and Respiratory Diseases, coverage with one or more doses of the Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) increased significantly from 41% of all U.S. teens in 2008 to 56% in 2009.
There was also a significant rise in coverage of the meningococcal conjugate vaccine (MenACWY), from 42% coverage in 2008 to 54% in 2009.
And, among females, there were similarly significant jumps both in the percentage of girls receiving at least one dose of the human papillomavirus (HPV) vaccine – from 37% to 44% – as well as girls receiving all three recommended doses, from 18% to 27%.
Nevertheless, there were some areas of stagnation. For example, coverage with two or more doses of the measles, mumps, rubella (MMR) vaccine was not significantly different from coverage during 2008 (89.1% in 2009 and 89.3% in 2008).
Looking at chickenpox, in 2009, “75.7% had protection from varicella disease (i.e., history of varicella or received [two or more] doses of VAR),” wrote the authors, up from 73.5% in 2008—an insignificant increase.
And coverage with three or more doses of the hepatitis B vaccine increased only slightly (although significantly), from 88% to 90%.
The report also breaks down vaccination according to state, with Mississippi coming in dead last for coverage with one of more doses of the MenACWY vaccine (19%), with one or more doses of Tdap (23%), and one or more doses of the HPV vaccine (23%).
Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, called the 2009 data “mixed” in an accompanying CDC press release. A complete breakdown of vaccination rates by state and nationally, going back to 2006, is available at the CDC.
“We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system’s ability to reach this age group,” she said. For example, “Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for preteens to receive the Tdap booster.”
Major Finding: Vaccination rates are increased among U.S. teens aged 13-17 years from 2008 to 2009 receiving at least one dose of the Tdap vaccine (from 41% to 56%), the MenACWY (from 42% to 54%), and at least one dose of the HPV vaccine (37% to 44%).
Data Source: The National Immunization Survey for Teens, conducted by the Centers for Disease Control and Prevention.
Disclosures: None was reported.
Adult Acne Often Comedonal, Tied to Smoking
Major Finding: Out of the study patients, 85% had CPPA.
Data Source: Postadolescent women (226) with acne, aged 25–50 years, seen at a clinic by three dermatologists.
Disclosures: The authors reported having no conflicts of interest.
Among adult females with acne, 85% have large and small comedones, with few inflammatory lesions, a study has shown.
The finding goes against the commonly held belief that postadolescent acne is more often associated with inflammatory papules and pustular lesions, suggesting that “the commonly accepted model for postadolescent female acne should be critically revised for important academic, pathogenetic, and therapeutic reasons,” according to study investigators.
Cigarette smoking was also found to be strongly correlated with the comedonal form of acne, and not the inflammatory, papulopustular type.
According to the investigators, led by Dr. Bruno Capitanio of the pediatric dermatology department at the San Gallicano Institute in Rome, postadolescent acne had previously been considered a “predominantly inflammatory, mild to moderate form, characterized by papules and pustules, mainly located on the lower third of the face, jawline, and neck, with rare and not prominent comedonal lesions.”
The authors classified this type as “papulopustular postadolescent acne,” or PPAA.
“However, we have previously reported a frequent clinical form characterized by a predominance of retention lesions (microcomedones and macrocomedones) with few inflammatory lesions,” which the investigators call “comedonal postadolescent acne,” or CPAA.
For the current study, Dr. Capitanio and his colleagues sought to characterize the prevalence and severity of PPAA and CPAA among a group of 226 postadolescent women with acne, aged 25–50 years, seen at his clinic by three dermatologists (J. Am. Acad. Dermatol. 2010 July 7 [doi:10.1016/j.jaad.2009.11.021]).
All patients were classified as either nonsmokers (patients who had quit smoking more than 5 years before the study) or current smokers (patients who had quit smoking within 6 months prior to the study).
In total, 85% (192) of the study patients had CPAA.
The authors also found that smoking was strongly correlated with the more predominant, CPAA form. Of the 150 patients in the study who smoked, 93% (140) were CPAA patients, accounting for nearly 73% of the total CPAA cohort.
In contrast, the 10 remaining smokers, who had PPAA, represented just under 30% of that group.
Additionally, “a positive correlation was found between number of daily cigarettes and CPAA severity,” wrote Dr. Capitanio and his associates. For example, among the 19 total patients in the study who reported smoking more than 20 cigarettes per day, 11 had what the authors characterized as “severe” CPAA, with cysts greater than 3 mm in diameter spread over the entire face, and the presence of “ice-pick” scarring lending a “crater effect.”
Seven of the heavy smokers (more than 20 cigarettes per day) had mild to moderate CPAA; the remaining one patient had PPAA.
The authors postulated that one reason for the discrepancy between their data and previous findings about postadolescent acne may be because prior studies have “been mainly conducted on Nordic (in particular Anglo-Saxon) populations, presumably (even if not specified) characterized by a predominance of fair skin type and by a low-grade ultraviolet exposure.” This study was of women of Mediterranean descent.
The authors conceded that the study did not take into account patients' stress levels, sleep, milk intake, or consumption of foods with high glycemic indices, “but they will be included in future studies.”
Major Finding: Out of the study patients, 85% had CPPA.
Data Source: Postadolescent women (226) with acne, aged 25–50 years, seen at a clinic by three dermatologists.
Disclosures: The authors reported having no conflicts of interest.
Among adult females with acne, 85% have large and small comedones, with few inflammatory lesions, a study has shown.
The finding goes against the commonly held belief that postadolescent acne is more often associated with inflammatory papules and pustular lesions, suggesting that “the commonly accepted model for postadolescent female acne should be critically revised for important academic, pathogenetic, and therapeutic reasons,” according to study investigators.
Cigarette smoking was also found to be strongly correlated with the comedonal form of acne, and not the inflammatory, papulopustular type.
According to the investigators, led by Dr. Bruno Capitanio of the pediatric dermatology department at the San Gallicano Institute in Rome, postadolescent acne had previously been considered a “predominantly inflammatory, mild to moderate form, characterized by papules and pustules, mainly located on the lower third of the face, jawline, and neck, with rare and not prominent comedonal lesions.”
The authors classified this type as “papulopustular postadolescent acne,” or PPAA.
“However, we have previously reported a frequent clinical form characterized by a predominance of retention lesions (microcomedones and macrocomedones) with few inflammatory lesions,” which the investigators call “comedonal postadolescent acne,” or CPAA.
For the current study, Dr. Capitanio and his colleagues sought to characterize the prevalence and severity of PPAA and CPAA among a group of 226 postadolescent women with acne, aged 25–50 years, seen at his clinic by three dermatologists (J. Am. Acad. Dermatol. 2010 July 7 [doi:10.1016/j.jaad.2009.11.021]).
All patients were classified as either nonsmokers (patients who had quit smoking more than 5 years before the study) or current smokers (patients who had quit smoking within 6 months prior to the study).
In total, 85% (192) of the study patients had CPAA.
The authors also found that smoking was strongly correlated with the more predominant, CPAA form. Of the 150 patients in the study who smoked, 93% (140) were CPAA patients, accounting for nearly 73% of the total CPAA cohort.
In contrast, the 10 remaining smokers, who had PPAA, represented just under 30% of that group.
Additionally, “a positive correlation was found between number of daily cigarettes and CPAA severity,” wrote Dr. Capitanio and his associates. For example, among the 19 total patients in the study who reported smoking more than 20 cigarettes per day, 11 had what the authors characterized as “severe” CPAA, with cysts greater than 3 mm in diameter spread over the entire face, and the presence of “ice-pick” scarring lending a “crater effect.”
Seven of the heavy smokers (more than 20 cigarettes per day) had mild to moderate CPAA; the remaining one patient had PPAA.
The authors postulated that one reason for the discrepancy between their data and previous findings about postadolescent acne may be because prior studies have “been mainly conducted on Nordic (in particular Anglo-Saxon) populations, presumably (even if not specified) characterized by a predominance of fair skin type and by a low-grade ultraviolet exposure.” This study was of women of Mediterranean descent.
The authors conceded that the study did not take into account patients' stress levels, sleep, milk intake, or consumption of foods with high glycemic indices, “but they will be included in future studies.”
Major Finding: Out of the study patients, 85% had CPPA.
Data Source: Postadolescent women (226) with acne, aged 25–50 years, seen at a clinic by three dermatologists.
Disclosures: The authors reported having no conflicts of interest.
Among adult females with acne, 85% have large and small comedones, with few inflammatory lesions, a study has shown.
The finding goes against the commonly held belief that postadolescent acne is more often associated with inflammatory papules and pustular lesions, suggesting that “the commonly accepted model for postadolescent female acne should be critically revised for important academic, pathogenetic, and therapeutic reasons,” according to study investigators.
Cigarette smoking was also found to be strongly correlated with the comedonal form of acne, and not the inflammatory, papulopustular type.
According to the investigators, led by Dr. Bruno Capitanio of the pediatric dermatology department at the San Gallicano Institute in Rome, postadolescent acne had previously been considered a “predominantly inflammatory, mild to moderate form, characterized by papules and pustules, mainly located on the lower third of the face, jawline, and neck, with rare and not prominent comedonal lesions.”
The authors classified this type as “papulopustular postadolescent acne,” or PPAA.
“However, we have previously reported a frequent clinical form characterized by a predominance of retention lesions (microcomedones and macrocomedones) with few inflammatory lesions,” which the investigators call “comedonal postadolescent acne,” or CPAA.
For the current study, Dr. Capitanio and his colleagues sought to characterize the prevalence and severity of PPAA and CPAA among a group of 226 postadolescent women with acne, aged 25–50 years, seen at his clinic by three dermatologists (J. Am. Acad. Dermatol. 2010 July 7 [doi:10.1016/j.jaad.2009.11.021]).
All patients were classified as either nonsmokers (patients who had quit smoking more than 5 years before the study) or current smokers (patients who had quit smoking within 6 months prior to the study).
In total, 85% (192) of the study patients had CPAA.
The authors also found that smoking was strongly correlated with the more predominant, CPAA form. Of the 150 patients in the study who smoked, 93% (140) were CPAA patients, accounting for nearly 73% of the total CPAA cohort.
In contrast, the 10 remaining smokers, who had PPAA, represented just under 30% of that group.
Additionally, “a positive correlation was found between number of daily cigarettes and CPAA severity,” wrote Dr. Capitanio and his associates. For example, among the 19 total patients in the study who reported smoking more than 20 cigarettes per day, 11 had what the authors characterized as “severe” CPAA, with cysts greater than 3 mm in diameter spread over the entire face, and the presence of “ice-pick” scarring lending a “crater effect.”
Seven of the heavy smokers (more than 20 cigarettes per day) had mild to moderate CPAA; the remaining one patient had PPAA.
The authors postulated that one reason for the discrepancy between their data and previous findings about postadolescent acne may be because prior studies have “been mainly conducted on Nordic (in particular Anglo-Saxon) populations, presumably (even if not specified) characterized by a predominance of fair skin type and by a low-grade ultraviolet exposure.” This study was of women of Mediterranean descent.
The authors conceded that the study did not take into account patients' stress levels, sleep, milk intake, or consumption of foods with high glycemic indices, “but they will be included in future studies.”
Drug Combo Bests Monotherapy for Esophagitis
Major Finding: Treatment with oral viscous budesonide plus a proton pump inhibitor led to a significant decrease in the mean peak esophageal eosinophil count, from 66.6 eosinophils/high-powered field pretreatment to 4.8 after 3 months of the daily therapy.
Data Source: A study published in the August issue of the journal Gastroenterology.
Disclosures: In addition to receiving funding from the maker of OVB, Dr. Dohil and two other researchers disclosed having a financial interest in the successful development and marketing of OVB. They also disclosed that the University of California, San Diego, where the investigators are employed, has a financial interest in Meritage Pharma Inc.
Oral viscous budesonide in combination with lansoprazole was significantly more effective for pediatric eosinophilic esophagitis than was the proton pump inhibitor alone, said Dr. Ranjan Dohil and his colleagues in Gastroenterology.
Although patients with negative allergy testing appeared to respond better, “patients testing positive do also respond and should also be considered for OVB [oral viscous budesonide] therapy,” the authors concluded, based on their randomized, double-blind, placebo-controlled trial (Gastroenterology 2010 [doi: 10.1053/j.gastro.2010.05.001]).
According to Dr. Dohil of the University of California, San Diego, Medical Center, the symptoms of eosinophilic esophagitis (EoE) are similar to those seen in gastroesophageal reflux disease but the condition is “often refractory to acid-suppression therapy,” and therefore “the optimal therapy for EoE is unclear.”
The current phase II study, sponsored by Meritage Pharma Inc., the maker of OVB, is the first placebo-controlled study to evaluate the drug, which is a viscous liquid consisting of budesonide nebulizer suspension (Pulmicort respules) mixed with sucralose (Splenda).
Dr. Dohil and colleagues studied 31 children diagnosed with EoE between February 2008 and July 2009; a total of 24 completed the study and were included in the analysis. All had esophageal eosinophil counts greater than or equal to 20 eosinophils per high-powered field (eos/hpf) except one patient, who had “panesophageal furrowing and exudates on endoscopy but a peak eosinophil count of 15”; this patient was also enrolled. In all, 20 patients were male, and the mean age was 7.8 years (range, 11-17 years).
Of the total 24 children, 15 received OVB and PPI and 9 received placebo and PPI. In the treatment group, the mean peak eosinophil count prior to OVB/PPI therapy was 66.6 eos/hpf. After 3 months of therapy, it had decreased significantly to 4.8 eos/hpf (P = .0001), with only one patient classified as a complete nonresponder. (The eosinophil count went from 67 to 47 eos/hpf in that patient.)
Moreover, the results were seen throughout the esophagus. Indeed, “87% of OVB post-treatment patients [had] less than or equal to 6 eos/hpf in the distal esophageal biopsies and 100% [had] less than or equal to 6 eos/hpf in proximal esophageal biopsies,” wrote the authors. In contrast, among patients treated with placebo plus the PPI, the mean eosinophil count went from 83.9 to 65.6 eos/hpf, and all patients were classified as nonresponders except for one partial responder, whose counts fell from 75 to 7.
The authors said the study's duration of 3 months did not allow for long-term follow-up, but that its data “support the need for a proprietary OVB medication specifically for the treatment of EoE.”
Major Finding: Treatment with oral viscous budesonide plus a proton pump inhibitor led to a significant decrease in the mean peak esophageal eosinophil count, from 66.6 eosinophils/high-powered field pretreatment to 4.8 after 3 months of the daily therapy.
Data Source: A study published in the August issue of the journal Gastroenterology.
Disclosures: In addition to receiving funding from the maker of OVB, Dr. Dohil and two other researchers disclosed having a financial interest in the successful development and marketing of OVB. They also disclosed that the University of California, San Diego, where the investigators are employed, has a financial interest in Meritage Pharma Inc.
Oral viscous budesonide in combination with lansoprazole was significantly more effective for pediatric eosinophilic esophagitis than was the proton pump inhibitor alone, said Dr. Ranjan Dohil and his colleagues in Gastroenterology.
Although patients with negative allergy testing appeared to respond better, “patients testing positive do also respond and should also be considered for OVB [oral viscous budesonide] therapy,” the authors concluded, based on their randomized, double-blind, placebo-controlled trial (Gastroenterology 2010 [doi: 10.1053/j.gastro.2010.05.001]).
According to Dr. Dohil of the University of California, San Diego, Medical Center, the symptoms of eosinophilic esophagitis (EoE) are similar to those seen in gastroesophageal reflux disease but the condition is “often refractory to acid-suppression therapy,” and therefore “the optimal therapy for EoE is unclear.”
The current phase II study, sponsored by Meritage Pharma Inc., the maker of OVB, is the first placebo-controlled study to evaluate the drug, which is a viscous liquid consisting of budesonide nebulizer suspension (Pulmicort respules) mixed with sucralose (Splenda).
Dr. Dohil and colleagues studied 31 children diagnosed with EoE between February 2008 and July 2009; a total of 24 completed the study and were included in the analysis. All had esophageal eosinophil counts greater than or equal to 20 eosinophils per high-powered field (eos/hpf) except one patient, who had “panesophageal furrowing and exudates on endoscopy but a peak eosinophil count of 15”; this patient was also enrolled. In all, 20 patients were male, and the mean age was 7.8 years (range, 11-17 years).
Of the total 24 children, 15 received OVB and PPI and 9 received placebo and PPI. In the treatment group, the mean peak eosinophil count prior to OVB/PPI therapy was 66.6 eos/hpf. After 3 months of therapy, it had decreased significantly to 4.8 eos/hpf (P = .0001), with only one patient classified as a complete nonresponder. (The eosinophil count went from 67 to 47 eos/hpf in that patient.)
Moreover, the results were seen throughout the esophagus. Indeed, “87% of OVB post-treatment patients [had] less than or equal to 6 eos/hpf in the distal esophageal biopsies and 100% [had] less than or equal to 6 eos/hpf in proximal esophageal biopsies,” wrote the authors. In contrast, among patients treated with placebo plus the PPI, the mean eosinophil count went from 83.9 to 65.6 eos/hpf, and all patients were classified as nonresponders except for one partial responder, whose counts fell from 75 to 7.
The authors said the study's duration of 3 months did not allow for long-term follow-up, but that its data “support the need for a proprietary OVB medication specifically for the treatment of EoE.”
Major Finding: Treatment with oral viscous budesonide plus a proton pump inhibitor led to a significant decrease in the mean peak esophageal eosinophil count, from 66.6 eosinophils/high-powered field pretreatment to 4.8 after 3 months of the daily therapy.
Data Source: A study published in the August issue of the journal Gastroenterology.
Disclosures: In addition to receiving funding from the maker of OVB, Dr. Dohil and two other researchers disclosed having a financial interest in the successful development and marketing of OVB. They also disclosed that the University of California, San Diego, where the investigators are employed, has a financial interest in Meritage Pharma Inc.
Oral viscous budesonide in combination with lansoprazole was significantly more effective for pediatric eosinophilic esophagitis than was the proton pump inhibitor alone, said Dr. Ranjan Dohil and his colleagues in Gastroenterology.
Although patients with negative allergy testing appeared to respond better, “patients testing positive do also respond and should also be considered for OVB [oral viscous budesonide] therapy,” the authors concluded, based on their randomized, double-blind, placebo-controlled trial (Gastroenterology 2010 [doi: 10.1053/j.gastro.2010.05.001]).
According to Dr. Dohil of the University of California, San Diego, Medical Center, the symptoms of eosinophilic esophagitis (EoE) are similar to those seen in gastroesophageal reflux disease but the condition is “often refractory to acid-suppression therapy,” and therefore “the optimal therapy for EoE is unclear.”
The current phase II study, sponsored by Meritage Pharma Inc., the maker of OVB, is the first placebo-controlled study to evaluate the drug, which is a viscous liquid consisting of budesonide nebulizer suspension (Pulmicort respules) mixed with sucralose (Splenda).
Dr. Dohil and colleagues studied 31 children diagnosed with EoE between February 2008 and July 2009; a total of 24 completed the study and were included in the analysis. All had esophageal eosinophil counts greater than or equal to 20 eosinophils per high-powered field (eos/hpf) except one patient, who had “panesophageal furrowing and exudates on endoscopy but a peak eosinophil count of 15”; this patient was also enrolled. In all, 20 patients were male, and the mean age was 7.8 years (range, 11-17 years).
Of the total 24 children, 15 received OVB and PPI and 9 received placebo and PPI. In the treatment group, the mean peak eosinophil count prior to OVB/PPI therapy was 66.6 eos/hpf. After 3 months of therapy, it had decreased significantly to 4.8 eos/hpf (P = .0001), with only one patient classified as a complete nonresponder. (The eosinophil count went from 67 to 47 eos/hpf in that patient.)
Moreover, the results were seen throughout the esophagus. Indeed, “87% of OVB post-treatment patients [had] less than or equal to 6 eos/hpf in the distal esophageal biopsies and 100% [had] less than or equal to 6 eos/hpf in proximal esophageal biopsies,” wrote the authors. In contrast, among patients treated with placebo plus the PPI, the mean eosinophil count went from 83.9 to 65.6 eos/hpf, and all patients were classified as nonresponders except for one partial responder, whose counts fell from 75 to 7.
The authors said the study's duration of 3 months did not allow for long-term follow-up, but that its data “support the need for a proprietary OVB medication specifically for the treatment of EoE.”