GJZH
11-15-2006, 01:32 AM
Abatacept for Rheumatoid Arthritis Well Tolerated After 2 Years
http://www.medscape.com/viewarticle/547766
Paula Moyer, MA
November 13, 2006 (Washington) — Patients with rheumatoid arthritis (RA) who have been treated with abatacept (Orencia) for 2 years or longer have no more frequent or unexpected adverse events than they do at the onset of treatment, according to an international team of investigators who presented their findings here at the 70th annual meeting of the American College of Rheumatology.
"Through 2 years of treatment, abatacept demonstrated a consistent safety profile in patients with active RA, including those with comorbidities," said Michael E. Weinblatt, MD, during his presentation. "There were no new signals in the open-label period."
Dr. Weinblatt added, "Taken together with similar findings, the results show that abatacept is generally safe and well tolerated and demonstrates improvements that are maintained." Dr. Weinblatt is a professor of medicine in the division of rheumatology and immunology at Brigham and Women's Hospital in Boston, Massachusetts, affiliated with Harvard Medical School.
In the double-blind phase of the Abatacept Study of Safety in Use with other Rheumatoid arthritis therapies (ASSURE), the 1413 patients received either abatacept or placebo on days 1, 15, and 29, and every 4 weeks thereafter. The treated patients received a dose of approximately 10 mg/kg. All patients also received additional treatment with one or more disease-modifying antirheumatic drugs (DMARDs), either conventional or biologic agents.
A total of 1221 patients completed the double-blind phase and 1184 patients entered an open-label extension, during which all patients received abatacept once monthly at 10 mg/kg in addition to background therapies as needed. Of the patients in the extension phase, 800 had been receiving abatacept and 384 had been receiving placebo.
A total of 1071 patients (90.5%) completed 1 year of the long-term extension. Most discontinuations were due to adverse events (n = 39; 3.3%), withdrawal of consent (n = 30; 2.5%), and lack of efficacy (n = 29; 2.4%). Nonbiological DMARDs were the most common add-on therapy; of those originally receiving abatacept, 725 were receiving nonbiological DMARDs and 75 were receiving biologicals. Of those originally receiving placebo, 342 were received nonbiological DMARDs and 42 received biologicals.
During the extension period, rates of serious adverse events, serious infections, and malignancies were distributed at similar rates to those seen in the double-blind period, Dr. Weinblatt said. The overall pattern and intensity of adverse events was also similar. The rate of malignant neoplasms was 1.6 per 100 patient-years during the double-blind period and 0.9 per 100 patient-years during the open-label period. Lung cancer occurred at rates of 0.3 per 100 patient-years during the double-blind period and 0.2 per 100 patient-years during the open-label period. As had been seen previously, abatacept-treated patients had improvements from baseline in all patient-reported outcomes, Dr. Weinblatt said.
"It was also interesting that, when followed for 2 years, the rate of adverse events did not accumulate," said Eric Matteson, MD, in an interview. "You didn't have more people getting sick the second year than the first year. There were no new problems in the follow-up year." Dr. Matteson is a professor of medicine at Mayo Clinic College of Medicine in Rochester, Minnesota, where he is a consultant in rheumatology.
"These are serious drugs for serious disease, and they change your immune system," Dr. Matteson said. "When you alter the immune system, it has consequences, and we don't yet know if these medications put people at a higher risk of cancer. Overall, the risk-benefit profile is good, but we need to know what the negative consequences are too. Although the rate of adverse events is low, they are there."
The study was funded by Bristol-Myers Squibb, which manufactures Orencia.
ACR 70th Annual Meeting: Abstract 509. Presented November 12, 2006.
http://www.medscape.com/viewarticle/547766
Paula Moyer, MA
November 13, 2006 (Washington) — Patients with rheumatoid arthritis (RA) who have been treated with abatacept (Orencia) for 2 years or longer have no more frequent or unexpected adverse events than they do at the onset of treatment, according to an international team of investigators who presented their findings here at the 70th annual meeting of the American College of Rheumatology.
"Through 2 years of treatment, abatacept demonstrated a consistent safety profile in patients with active RA, including those with comorbidities," said Michael E. Weinblatt, MD, during his presentation. "There were no new signals in the open-label period."
Dr. Weinblatt added, "Taken together with similar findings, the results show that abatacept is generally safe and well tolerated and demonstrates improvements that are maintained." Dr. Weinblatt is a professor of medicine in the division of rheumatology and immunology at Brigham and Women's Hospital in Boston, Massachusetts, affiliated with Harvard Medical School.
In the double-blind phase of the Abatacept Study of Safety in Use with other Rheumatoid arthritis therapies (ASSURE), the 1413 patients received either abatacept or placebo on days 1, 15, and 29, and every 4 weeks thereafter. The treated patients received a dose of approximately 10 mg/kg. All patients also received additional treatment with one or more disease-modifying antirheumatic drugs (DMARDs), either conventional or biologic agents.
A total of 1221 patients completed the double-blind phase and 1184 patients entered an open-label extension, during which all patients received abatacept once monthly at 10 mg/kg in addition to background therapies as needed. Of the patients in the extension phase, 800 had been receiving abatacept and 384 had been receiving placebo.
A total of 1071 patients (90.5%) completed 1 year of the long-term extension. Most discontinuations were due to adverse events (n = 39; 3.3%), withdrawal of consent (n = 30; 2.5%), and lack of efficacy (n = 29; 2.4%). Nonbiological DMARDs were the most common add-on therapy; of those originally receiving abatacept, 725 were receiving nonbiological DMARDs and 75 were receiving biologicals. Of those originally receiving placebo, 342 were received nonbiological DMARDs and 42 received biologicals.
During the extension period, rates of serious adverse events, serious infections, and malignancies were distributed at similar rates to those seen in the double-blind period, Dr. Weinblatt said. The overall pattern and intensity of adverse events was also similar. The rate of malignant neoplasms was 1.6 per 100 patient-years during the double-blind period and 0.9 per 100 patient-years during the open-label period. Lung cancer occurred at rates of 0.3 per 100 patient-years during the double-blind period and 0.2 per 100 patient-years during the open-label period. As had been seen previously, abatacept-treated patients had improvements from baseline in all patient-reported outcomes, Dr. Weinblatt said.
"It was also interesting that, when followed for 2 years, the rate of adverse events did not accumulate," said Eric Matteson, MD, in an interview. "You didn't have more people getting sick the second year than the first year. There were no new problems in the follow-up year." Dr. Matteson is a professor of medicine at Mayo Clinic College of Medicine in Rochester, Minnesota, where he is a consultant in rheumatology.
"These are serious drugs for serious disease, and they change your immune system," Dr. Matteson said. "When you alter the immune system, it has consequences, and we don't yet know if these medications put people at a higher risk of cancer. Overall, the risk-benefit profile is good, but we need to know what the negative consequences are too. Although the rate of adverse events is low, they are there."
The study was funded by Bristol-Myers Squibb, which manufactures Orencia.
ACR 70th Annual Meeting: Abstract 509. Presented November 12, 2006.