Details

Autor(en) / Beteiligte

• Menter, Alan, MD
• Tyring, Stephen K., MD, PhD, MBA
• Gordon, Kenneth, MD
• Kimball, Alexa B., MD, MPH
• Leonardi, Craig L., MD
• Langley, Richard G., MD
• Strober, Bruce E., MD, PhD
• Kaul, Martin, MD
• Gu, Yihua, MS
• Okun, Martin, MD, PhD
• Papp, Kim, MD

Titel

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

Ist Teil von

• Journal of the American Academy of Dermatology, 2008, Vol.58 (1), p.106-115

Ort / Verlag

New York, NY: Mosby, Inc

Erscheinungsjahr

2008

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• 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.