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

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.

• Authors: Alan Menter, Stephen K Tyring, Kenneth Gordon, Alexa B Kimball, Craig L Leonardi, Richard G Langley, Bruce E Strober, Martin Kaul, Yihua Gu, Martin Okun, Kim Papp
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 58 Issue 1 Pg. 106-15 (Jan 2008) ISSN: 1097-6787 [Electronic] United States
• PMID: 17936411 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Tumor Necrosis Factor-alpha
• Adalimumab

Topics

• Adalimumab
• Adult
• Antibodies, Monoclonal (adverse effects, immunology, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy, pathology)
• Severity of Illness Index
• Time Factors
• Treatment Outcome
• Tumor Necrosis Factor-alpha (immunology)