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

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. Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patient...

Full description

Saved in:
Bibliographic Details
Published in:Journal of cutaneous medicine and surgery 2005-12, Vol.9 (6), p.313-323
Main Authors: PAPP, Kim A, CAMISA, Charles, STONE, Stephen P, CARO, Ivor, XIAOLIN WANG, COMPTON, Peter, WALICKE, Patricia A, GOTTLIEB, Alice B
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - therapeutic use
Biological and medical sciences
Chronic Disease
Clinical trials
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Data Interpretation, Statistical
Dermatology
Double-Blind Method
Female
Humans
Injections, Intravenous
Injections, Subcutaneous
Male
Medical research
Medical sciences
Middle Aged
Pharmaceuticals
Placebos
Psoriasis
Psoriasis - drug therapy
Psoriasis. Parapsoriasis. Lichen
Randomized Controlled Trials as Topic
Safety
Time Factors
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. 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. Efalizumab was well tolerated, with a favorable safety profile.
ISSN:1203-4754
1615-7109
DOI:10.1007/s10227-005-0117-0