Clinical response to alimumab treatment in patients with moderate to severe psoriasis: Double-blind, randomized controlled trial and open-label extension study

Background: Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G(1) antibody that neutralizes tumor necrosis factor. Objectives: We sought to assess the efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis. Methods: In this multicenter, randomized, double-blind, placebo-controlled study, 147 patients received adalimumab (40 mg every other week or 40 mg/wk) or placebo. After 12 weeks of blinded therapy, patients taking adalimumab could continue their assigned dosages in a 48-week extension trial; patients taking placebo were switched to adalimumab (40 mg every other week). Results: At week 12, 53% of patients taking adalimumab every other week, 80% of patients taking adalimumab weekly, and 4% of patients taking placebo achieved 75% improvement in Psoriasis Area and Severity Index score (P <.001). Responses were sustained for 60 weeks. No new safety signals were noted compared with the existing adalimumab clinical safety database. Limitations. The study was insufficiently powered to detect rare adverse events associated with adalimumab. Conclusions: Adalimumab significantly improved psoriasis and was well tolerated for 60 weeks.