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

Author(s): Gordon KB, Langley RG, Leonardi C, Toth D, Menter MA, Kang S, Heffernan M, Miller B, Hamlin R, Lim L, Zhong J, Hoffman R, Okun MM

Affiliation(s): Division of Dermatology, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Skokie, IL 60077, USA. kgordon@enh.org

Publication date & source: 2006-10, J Am Acad Dermatol., 55(4):598-606. Epub 2006 Aug 10.

Publication type: Multicenter Study; Randomized Controlled Trial

BACKGROUND: Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G1 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.