Abstract
Background: The efficacy and safety of efalizumab have been evaluated in multiple clinical trials. ObjectiveThe purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials. Methods: Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13—60 weeks of efalizumab therapy were pooled to evaluate longer-term safety. Results: The most common adverse events were mild to moderate, self-limiting, flulike symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients. Conclusion: Efalizumab was well tolerated, with a favorable safety profile.
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