Background: The efficacy and safety of efalizumab have been evaluated in multiple clinical trials.
Objective: The 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, flu-like 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.