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J Am Acad Dermatol. 2008 Jan;58(1):106-15. Epub 2007 Oct 23.

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

Author information

  • 1Division of Dermatology, Baylor Research Institute, University of Texas Southwestern Medical School, 3900 Junius St, 125, Dallas, TX 75246-1613, USA. amderm@gmail.com

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.

PMID:
17936411
[PubMed - indexed for MEDLINE]
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