Etanercept monotherapy in patients with psoriasis: a summary of safety, based on an integrated multistudy database.
BACKGROUND
Etanercept, a tumor necrosis factor antagonist, is an approved treatment in the United States and Europe for plaque psoriasis.


OBJECTIVE
To further examine the safety profile of etanercept in patients with chronic, moderate to severe plaque psoriasis.


METHODS
Safety data from an integrated database of 1347 patients from 3 randomized, double-blind, placebo-controlled clinical trials were analyzed. Safety end points included incidence rates of adverse events, serious adverse events, infections, serious infections, injection site reactions, and routine laboratory assessments. Pooled safety results from the first 12 weeks of each trial are reported here.


RESULTS
Rates of adverse events, serious adverse events, infections, and serious infections in the first 12 weeks of the 3 trials were similar among all active groups as well as each active group, compared with the placebo group. No dose-related toxicities were reported.


CONCLUSIONS
This report includes a relatively short (12-week) time frame; data from patients exposed to etanercept for longer periods are needed.


CONCLUSIONS
Etanercept was generally safe in a large cohort of patients with moderate to severe plaque psoriasis.
Gottlieb
Alice B
AB
Clinical Research Center, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA. alice.gottlieb@umdnj.edu
Leonardi
Craig L
CL
Goffe
Bernard S
BS
Ortonne
Jean-Paul
JP
van der Kerkhof
Peter C M
PC
Zitnik
Ralph
R
Nakanishi
Arline
A
Jahreis
Angelika
A
D000328:Adult; D002908:Chronic Disease; D015897:Comorbidity; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000453:epidemiology; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000037:antagonists & inhibitors / Q000627:therapeutic use*
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept