Efficacy and safety of efalizumab in patients with moderate to severe plaque psoriasis: Pooled results from three phase III randomized, placebo-controlled trials

Abstract

Rationale Data from 3 trials were pooled to assess the efficacy and safety of efalizumab, a humanized monoclonal IgG 1 antibody against the α-subunit (CD11a) of leukocyte function-associated antigen-1, in patients with moderate to severe plaque psoriasis. Methods In 3 Phase III randomized, placebo-controlled trials of similar design for weeks 1-12, patients were randomized to subcutaneous efalizumab 1 mg/kg/wk (n=763), efalizumab 2 mg/kg/wk (n=409; 2 of 3 studies), or placebo (n=479) for 12 weeks. Results At Week 12, 28% of all efalizumab-treated patients achieved ≥75% Psoriasis-area-and-severity-index improvement (PASI-75) at Week 12, relative to baseline (vs 4% placebo; P<.001, both comparisons), and 57% and 55% of patients in the efalizumab 1 mg/kg/wk- and 2 mg/kg/wk-dose groups achieved PASI-50 (vs 15% placebo; P<.001, both comparisons). The mean percent PASI improvement at Week 12 was significantly greater in the efalizumab-treated patients at Week 2 ( P=.0001, efalizumab vs placebo). The most common adverse events (≥5% of all patients) were headache, nonspecific infection (eg, common colds), nausea, chills, pain, fever, asthenia, myalgia, pharyngitis, diarrhea, accidental injury, and rhinitis. The majority of the most frequently reported adverse events occurred during the first two doses of efalizumab and were classified as acute adverse events. By the third dose, the incidence of acute adverse events in the efalizumab and placebo groups was comparable. Conclusion Efalizumab provides clinically significant improvement in symptoms as early as 2 weeks. Thus, in combination with the demonstrated safety profile, supports the use of efalizumab for the treatment of moderate to severe plaque psoriasis.