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J Am Acad Dermatol. 2006 Oct;55(4):598-606. Epub 2006 Aug 10.

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

Author information

1
Division of Dermatology, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Skokie, IL 60077, USA. kgordon@enh.org

Abstract

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.

PMID:
17010738
DOI:
10.1016/j.jaad.2006.05.027
[Indexed for MEDLINE]

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