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Erschienen in:
01.12.2005
Clinical Efficacy of Efalizumab in Patients With Chronic Plaque Psoriasis: Results From Three Randomized Placebo-Controlled Phase III Trials: Part I
Erschienen in: Journal of Cutaneous Medicine and Surgery | Ausgabe 6/2005
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Background
Effective psoriasis therapies are needed for long-term symptom control.
Objective
Assess 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.
Results
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.