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

• Published in: Journal of cutaneous medicine and surgery 2005-12, Vol.9 (6), p.303-312
• Main Authors: Pariser, David M., Gordon, Kenneth B., Papp, Kim A., Leonardi, Craig L., Kwon, Paul, Compton, Peter G., Rundle, Amy Chen, Walicke, Patricia A., Lebwohl, Mark
• Format: Article
• Language: English
• ISSN: 1203-4754; 1615-7109
• DOI: 10.1177/120347540500900606

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.