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

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

*Corresponding author for this work

Research output: Contribution to journalArticle

641 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)106-115
Number of pages10
JournalJournal of the American Academy of Dermatology
Volume58
Issue number1
DOIs
StatePublished - Jan 1 2008

ASJC Scopus subject areas

  • Dermatology

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    Menter, A., Tyring, S. K., Gordon, K. B., Kimball, A. B., Leonardi, C. L., Langley, R. G., Strober, B. E., Kaul, M., Gu, Y., Okun, M., & Papp, K. (2008). Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal of the American Academy of Dermatology, 58(1), 106-115. https://doi.org/10.1016/j.jaad.2007.09.010