Abstract
IntroductionPatients with active rheumatoid arthritis who had failed at least one disease-modifying anti-rheumatic drug (DMARD) were treated with adalimumab (ADA) in the ReAct study with the option to continue treatment for 5 years in ReAlise. The purpose of this study was to evaluate the long-term safety and effectiveness of ADA as prescribed from the first injection in ReAct to the last observation in ReAlise.MethodsPatients received ADA alone or in combination with DMARDs according to usual clinical care practices. Adverse events (AEs) were tabulated by five time windows after the first ADA injection. Effectiveness measures included achievement of low disease activity (LDA), defined as Simplified Disease Activity Index (SDAI) ≤11, or remission, (REM), defined as SDAI ≤3.3.ResultsOf the 6,610 ReAct patients, 3,435 (52%) continued in ReAlise. At baseline in ReAct, mean age was 54 years, mean DAS28 was 6.0 and mean HAQ DI was 1.64. The mean treatment duration was 1,016 days, representing 18,272 patient-years (PYs) of ADA exposure. Overall incidence rates of serious AEs and serious infections were 13.8 and 2.8 events (E)/100 PYs, respectively. Serious AEs occurred most frequently in the first 6 months and deceased thereafter. Standardised mortality ratio was 0.71 (95% CI 0.57 to 0.87) and standardised incidence ratio for malignancies was 0.64 (95% CI 0.53 to 0.76). LDA was achieved by 50% and REM by 21% of patients at last observation.ConclusionsResults of this large observational study of ADA in routine clinical practice were consistent with controlled trials, with no new safety concerns during a follow-up of more than 5 years. Effectiveness of ADA was maintained during long-term observation.Trial registrationNCT00448383, NCT00234884
Highlights
Patients with active rheumatoid arthritis who had failed at least one disease-modifying antirheumatic drug (DMARD) were treated with adalimumab (ADA) in the ReAct study with the option to continue treatment for 5 years in ReAlise
Withdrawals were generally evenly distributed across time intervals, without obvious clusters of withdrawals occurring for specific reasons
Patients enrolled in ReAct and ReAlise reflect typical rheumatoid arthritis (RA) patients treated with tumour necrosis factor (TNF) antagonists, who have long-standing RA with moderate to severe baseline disease activity despite treatment with DMARDs
Summary
Patients with active rheumatoid arthritis who had failed at least one disease-modifying antirheumatic drug (DMARD) were treated with adalimumab (ADA) in the ReAct study with the option to continue treatment for 5 years in ReAlise. The purpose of this study was to evaluate the long-term safety and effectiveness of ADA as prescribed from the first injection in ReAct to the last observation in ReAlise. The Research in Active Rheumatoid Arthritis (ReAct) phase 3b study was initiated in 2002 to assess the safety and effectiveness of ADA in RA patients who had failed treatment with at least one traditional DMARD [11,12]. To evaluate the long-term safety and effectiveness of ADA in clinical practice settings over 5 years in patients who completed ReAct, the REgistry of HUMIRATM in RA: a Long-Term Investigation of Safety and Efficacy (ReAlise) observational follow-up study was conducted (NCT00234884). The primary objectives of this analysis include examination of adverse events (AEs) and the temporal pattern of their occurrence and maintenance of response through 5 years of ADA treatment (i.e., from the first injection received in ReAct through the last observation in ReAlise)
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