Clinical Efficacy of Efalizumab in Patients With Chronic Plaque Psoriasis: Results From Three Randomized Placebo-Controlled Phase III Trials: Part I
| Autor: | Peter Compton, Mark Lebwohl, David M. Pariser, Kenneth B. Gordon, Amy Chen Rundle, Patricia A. Walicke, Kim A. Papp, Paul Kwon, Craig L. Leonardi |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Randomization Adolescent Injections Subcutaneous Efalizumab Dermatology 030204 cardiovascular system & hematology Antibodies Monoclonal Humanized Placebo Gastroenterology Body Mass Index Cohort Studies Placebos 03 medical and health sciences 0302 clinical medicine Psoriasis Area and Severity Index Statistical significance Psoriasis Internal medicine medicine Humans Multicenter Studies as Topic 030212 general & internal medicine Adverse effect Aged Randomized Controlled Trials as Topic business.industry Antibodies Monoclonal Middle Aged medicine.disease Surgery Clinical trial Treatment Outcome Clinical Trials Phase III as Topic Data Interpretation Statistical Chronic Disease Female business medicine.drug |
| Zdroj: | Journal of Cutaneous Medicine and Surgery. 9:303-312 |
| ISSN: | 1615-7109 1203-4754 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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