Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial.

ABSTRACT

BACKGROUND: Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis. OBJECTIVE: We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy. METHODS: We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study. RESULTS: At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab. LIMITATIONS: Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations. CONCLUSION: Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis. TRIAL REGISTRATION Clinical trials.gov. NCT00237887.