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Adalimumab effective, safe in 5-year RA study
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Adalimumab was well tolerated and effective during more than 5 years of therapy in patients with active rheumatoid arthritis, according to recent study results.
Gerd R. Burmester, MD, clinical rheumatologist at the Charité – University Medicine, Berlin, and colleagues studied 6, 610 patients with active rheumatoid arthritis (RA; mean age, 53.7 years; 80.7% women) in the Research in Active Rheumatoid Arthritis (ReAct) phase 3b trial. All were treated with adalimumab (ADA), and for patients who completed at least 3 months, the optional 5-year ReAlise extension phase was conducted with 3,435 (52%) patients. Long-term safety and efficacy of the first ADA injection in the ReAct trial to the last observation in ReAlise was measured.
ADA was given to patients alone or in combination with disease-modifying antirheumatic drugs. Adverse events (AEs) were measured five times. Simplified Disease Activity Index (SDAI) of no more than 11 or remission (REM), defined as SDAI of 3.3 or less, were used to measure effectiveness and achievement of low disease activity (LDA).
Among ReAlise patients, 1,805 (52.5%) completed the long-term study with 5 years or more of ADA therapy.
Mean Disease Activity Score 28, based on erythrocyte sedimentation rate, was 6.0, and mean Health Assessment Questionnaire-Disability Index was 1.64 at baseline in the ReAct trial. ADA treatment had a mean duration of 1,106 days (18,272 patient-years [PYs]). Overall incidence rates were 13.8 events/100 PYs for serious AEs, most occurring within the first 6 months of treatment, and 2.8 events/100 PYs for serious infections.
Standardized mortality and malignancy incidence ratios were 0.71; 95% CI, 0.57-0.87 and 0.64; 95% CI, 0.53-0.76, respectively.
At final observation, 50% of patients achieved LDA, while 21% attained REM.
“The combined data from ReAct and ReAlise … provide one of the largest well-monitored evaluations of the long-term safety of a single [tumor necrosis factor] antagonist in routine clinical practice settings,” the researchers concluded.
Disclosure: See the study for a full list of relevant financial disclosures.
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