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. LIMITATIONS: 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.
RCT Entities:
BACKGROUND: Etanercept, a tumornecrosis 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. LIMITATIONS: 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.