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


CONCLUSIONS
Efalizumab was well tolerated, with a favorable safety profile.
Papp
Kim A
KA
University of Western Ontario, Waterloo, ONT, Canada. kapapp@probitymedical.com
Camisa
Charles
C
Stone
Stephen P
SP
Caro
Ivor
I
Wang
Xiaolin
X
Compton
Peter
P
Walicke
Patricia A
PA
Gottlieb
Alice B
AB
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002908:Chronic Disease; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D013997:Time Factors
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; C472181:efalizumab