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

Kenneth B. Gordon*, Richard G. Langley, Craig Leonardi, Darryl Toth, M. Alan Menter, Sewon Kang, Michael Heffernan, Bruce Miller, Regina Hamlin, Liberata Lim, Jianhua Zhong, Rebecca Hoffman, Martin M. Okun

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

422 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)598-606
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume55
Issue number4
DOIs
StatePublished - Oct 2006

ASJC Scopus subject areas

  • Dermatology

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