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Clinical efficacy of efalizumab in patients with chronic plaque psoriasis: results from three randomized placebo-controlled Phase III trials: part I. J Cutan Med Surg 2005 Dec;9(6):303-12

Date

05/16/2006

Pubmed ID

16699904

DOI

10.1007/s10227-005-0116-1

Scopus ID

2-s2.0-33749322774 (requires institutional sign-in at Scopus site)   30 Citations

Abstract

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 > 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.

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.

Author List

Pariser DM, Gordon KB, Papp KA, Leonardi CL, Kwon P, Compton PG, Rundle AC, Walicke PA, Lebwohl M

Author

Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Aged
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Body Mass Index
Chronic Disease
Clinical Trials, Phase III as Topic
Cohort Studies
Data Interpretation, Statistical
Female
Humans
Injections, Subcutaneous
Male
Middle Aged
Multicenter Studies as Topic
Placebos
Psoriasis
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome