The STAR (Safety Trial of Adalimumab in RA) trial assessed the safety and efficacy of adalimumab in a heterogeneous group of RA patients with persistent disease activity despite concomitant DMARD therapy. In this randomized, double-blind, placebo-controlled, multicenter study, 636 RA patients receiving 0 to 3 DMARDs received placebo or adalimumab 40 mg e.o.w. for 24 weeks while continuing their baseline DMARDs. Patients treated with adalimumab achieved statistically superior ACR20, 50, and 70 responses at Week 24 compared with placebo-treated patients (see Table 3.2). There were no statistically significant differences between the adalimumab and placebo groups in their respective rates of adverse events (AEs), serious AEs, severe or life-threatening AEs, or AEs leading to withdrawal. In addition, rates of infections or serious infections did not vary between the groups, suggestive of a favorable safety profile of adalimumab in patients receiving standard DMARDs (Furst et al. 2003).
Further assessment of adalimumab in a broad RA population was achieved through ReAct (Research in
Active Rheumatoid Arthritis Trial), a trial conducted to establish efficacy and safety in real-life clinical practice. ReAct represents the largest cohort of RA patients to be treated with a TNF antagonist in a study setting: 6,610 RA patients with active disease received adalimumab 40 mg e.o.w. for 12 weeks in addition to their current anti-rheumatic standard therapy, thus providing valuable information on the drug's performance in patients treated with various DMARDs, including patients with previous biologic experience. Patients were offered the option of continuing adalimumab in an extension phase of the study. Enrollment criteria for ReAct mirrored national guidelines for anti-TNF treatment in participant countries (11 European countries plus Australia). At Week 12, 69%, 40%, and 18% of patients achieved an ACR20, 50, and 70 response, 83% of patients achieved a moderate EULAR response, and 33 % a good EULAR response. Response rates were maintained over time in patients who continued adali-mumab treatment for 52 weeks in the extension phase (Burmester et al. 2005). Improvements in clinical and functional status, as measured by the Disease Activity Score in 28 joints (DAS28) and the disability index of the HAQ, also were clinically significant and sustained over time. In patients who had received prior TNF antagonists, the ACR20 response rate was high, at 60 %, though somewhat lower than in patients who were naive to TNF antagonists (70%). Patients with and without previous anti-TNF treatment experienced a statistically significant reduction in disease activity and disability at Week 12. These results indicate that even after treatment failure with a TNF antagonist, a clinically important response can be achieved with a different agent of the same class (Burmester et al. 2004, 2005; data on file).
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