Faculty Collaboration Database

Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: a phase IIIb, randomized, controlled trial. Int J Dermatol 2006 May;45(5):605-14

Date

05/17/2006

Pubmed ID

16700803

DOI

10.1111/j.1365-4632.2006.02777.x

Scopus ID

2-s2.0-33646167222 (requires institutional sign-in at Scopus site)   72 Citations

Abstract

BACKGROUND: To provide safety data for efalizumab, a recombinant humanized monoclonal IgG(1) antibody, in adults with chronic plaque psoriasis.

METHODS: A 12-week, Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled trial. At 58 study sites in the USA and Canada, 686 patients with moderate to severe chronic plaque psoriasis received an initial conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) followed by either 11 weekly doses of efalizumab 1 mg/kg SC or matching placebo. Main outcome measures were safety and tolerability outcomes (primary) and efficacy outcomes (secondary).

RESULTS: During 12 weeks of therapy with efalizumab or placebo, the incidence of clinical adverse events was 82.2% and 72.9%, respectively; the incidence of serious adverse events was 1.8% and 3.4%, respectively; and the incidence of nonserious adverse events leading to withdrawal was 1.8% and 1.7%, respectively. In the efalizumab group, there were no clinically significant changes in vital signs or laboratory parameters and no evidence of end-organ toxicities. A significantly higher proportion of patients receiving efalizumab than those receiving placebo achieved > or = 75% improvement in the Psoriasis Area and Severity Index (PASI) (P < 0.001), > or = 50% improvement in PASI (P < 0.001), and a static Physician's Global Assessment rating of Minimal or Clear (P < 0.001). The mean improvement in the Psoriasis Symptom Assessment was significantly greater in the efalizumab group (P < 0.001).

CONCLUSIONS: Efalizumab treatment SC for 12 weeks was safe, well tolerated, and effective in patients with moderate to severe chronic plaque psoriasis.

Author List

Papp KA, Bressinck R, Fretzin S, Goffe B, Kempers S, Gordon KB, Caro I, Walicke PA, Wang X, Menter A, Efalizumab Study Group

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
CD11 Antigens
Chronic Disease
Dermatologic Agents
Double-Blind Method
Female
Humans
Injections, Subcutaneous
Male
Middle Aged
Ontario
Psoriasis
Severity of Illness Index
Treatment Outcome