TY - JOUR
T1 - Clinical efficacy of efalizumab in patients with chronic plaque psoriasis
T2 - Results from three randomized placebo-controlled phase III trials: Part I
AU - Pariser, David M.
AU - Gordon, Kenneth B
AU - Papp, Kim A.
AU - Leonardi, Craig L.
AU - Kwon, Paul
AU - Compton, Peter G.
AU - Rundle, Amy Chen
AU - Walicke, Patricia A.
AU - Lebwohl, Mark
PY - 2005/12/1
Y1 - 2005/12/1
N2 - Background: Effective psoriasis therapies are needed for long-term symptom control. 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.
AB - Background: Effective psoriasis therapies are needed for long-term symptom control. 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.
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U2 - 10.1007/s10227-005-0116-1
DO - 10.1007/s10227-005-0116-1
M3 - Article
C2 - 16699904
AN - SCOPUS:33749322774
VL - 9
SP - 303
EP - 312
JO - Journal of Cutaneous Medicine and Surgery
JF - Journal of Cutaneous Medicine and Surgery
SN - 1203-4754
IS - 6
ER -