Clinical efficacy of efalizumab in patients with chronic plaque psoriasis : Results from three randomized placebo-controlled. Phase III trials: Part I

Effective psoriasis therapies are needed for long-term symptom control. Assess efalizumab (Raptiva) efficacy in a large cohort of psoriasis patients. Data from three Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies were pooled. Patients (n = 1,651) with mo...

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Bibliographic Details
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, LEBWOBL, Mark
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - therapeutic use
Biological and medical sciences
Body Mass Index
Chronic Disease
Clinical trials
Clinical Trials, Phase III as Topic
Cohort Studies
Data Interpretation, Statistical
Dermatology
Effectiveness
Female
Humans
Injections, Subcutaneous
Male
Medical sciences
Medical treatment
Middle Aged
Multicenter Studies as Topic
Pharmaceuticals
Placebos
Psoriasis
Psoriasis - drug therapy
Psoriasis. Parapsoriasis. Lichen
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
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Summary:Effective psoriasis therapies are needed for long-term symptom control. Assess efalizumab (Raptiva) efficacy in a large cohort of psoriasis patients. 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. All efficacy measures reached statistical significance within each of the individual studies (p < 0.001) and overall. More efalizumab-treated patients achieved > or = 75% and > or = 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. Efalizumab resulted in early and significant improvement for all efficacy endpoints and was well tolerated in patients with moderate to severe chronic plaque psoriasis.
ISSN:1203-4754
1615-7109
DOI:10.1007/s10227-005-0116-1