Clinical Efficacy of Efalizumab in Patients with Chronic Plaque Psoriasis: Results from Three Randomized Placebo-Controlled Phase III Trials: Part I

Abstract

Background: Effective psoriasis therapies are needed for long-term symptom control. ObjectiveAssess efalizumab (Raptiva®) efficacy in a large cohort of psoriasis patients. Methods: Data from three Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies were pooled. Patients ( n = 1,651) with moderate to severe plaque psoriasis received 12 weeks of subcutaneous efalizumab 1 or 2 mg/kg/wk or placebo. Remits: All efficacy measures reached statistical significance within each of the individual studies ( p < 0.001) and overall. More efalizumab-treated patients achieved > 75% and ≥ 50% Psoriasis Area and Severity Index (PASI) improvement at week 12 than did placebo-treated patients (27.8% vs 3.8% [ p < 0.001] and 56.1% vs 14.6% [ p < 0.001], respectively). Significant PASI improvements occurred as early as week 2 (12.5% vs 7.9%, p =0.0001). Adverse events were generally mild to moderate. Conclusion: Efalizumab resulted in early and significant improvement for all efficacy endpoints and was well tolerated in patients with moderate to severe chronic plaque psoriasis.