Adalimumab in the Treatment of Psoriasis: Pooled Efficacy and Safety Results from Three Pivotal Studies

BACKGROUND: Adalimumab, a fully human monoclonal antibody, binds to and neutralizes tumor necrosis factor. OBJECTIVE: To provide an integrated review of efficacy and safety from adalimumab clinical trials in psoriasis. METHODS: Pooled analyses were conducted of three placebo-controlled clinical trials of adalimumab (40 mg every other week) in psoriasis patients. The primary efficacy measure was the Psoriasis Area Severity Index (PASI). The Physician's Global Assessment (PGA) was also assessed. RESULTS: At Week 16, mean percentage PASI improvement was 78.3% for adalimumab-treated patients versus 15.1% for placebo-treated patients. A PGA of "Clear" or "Minimal" was achieved in 63.4% of adalimumab-treated patients versus 5.1% of placebo-treated patients. The response to adalimumab was rapid, with significant improvements for adalimumab-treated patients in most efficacy measures by Week 4. Adverse event incidence was similar between treatment groups and consistent with adalimumab safety profiles in other indications. CONCLUSION: Adalimumab improved psoriasis and was generally safe and well-tolerated.