Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis: Review of clinical data. Part II

Kim A. Papp, Charles Camisa, Stephen P. Stone, Ivor Caro, Xiaolin Wang, Peter Compton, Patricia A. Walicke, Alice B. Gottlieb

Research output: Contribution to journalReview articlepeer-review

28 Scopus citations

Abstract

Background: The efficacy and safety of efalizumab have been evaluated in multiple clinical trials. 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.

Original languageEnglish
Pages (from-to)313-323
Number of pages11
JournalJournal of Cutaneous Medicine and Surgery
Volume9
Issue number6
DOIs
StatePublished - Dec 2005
Externally publishedYes

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