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.
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Authors | Kim A Papp, Reni Bressinck, Scott Fretzin, Bernard Goffe, Steven Kempers, Kenneth B Gordon, Ivor Caro, Patricia A Walicke, Xiaolin Wang, Alan Menter, Efalizumab Study Group |
Journal | International journal of dermatology
(Int J Dermatol)
Vol. 45
Issue 5
Pg. 605-14
(May 2006)
ISSN: 0011-9059 [Print] England |
PMID | 16700803
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- CD11 Antigens
- Dermatologic Agents
- efalizumab
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Topics |
- Adolescent
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage, therapeutic use)
- Antibodies, Monoclonal, Humanized
- CD11 Antigens
(immunology)
- Chronic Disease
- Dermatologic Agents
(administration & dosage, therapeutic use)
- Double-Blind Method
- Female
- Humans
- Injections, Subcutaneous
- Male
- Middle Aged
- Ontario
- Psoriasis
(drug therapy, pathology)
- Severity of Illness Index
- Treatment Outcome
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