A randomized trial of etanercept as monotherapy for XXXX .

@entity1 @entity1569
OBJECTIVE: To determine safety and efficacy of monotherapy with etanercept. DESIGN: Randomized, double-blind, placebo-controlled, multicenter study. SETTING: Outpatient, ambulatory; private practice and university dermatology research centers. @entity1 : @entity1 aged at least 18 years, with @entity1569 involving 10% or more of body surface area; 148 were screened and 112 were randomly assigned to treatment groups and received study drug. INTERVENTIONS: @entity1 received placebo or etanercept, 25 mg, subcutaneously twice a week for 24 weeks. Other @entity1569 therapies were limited during the study. MAIN OUTCOME MEASURES: Safety measurements included tracking of adverse events and laboratory values. Efficacy was evaluated using the Psoriasis Area and Severity Index (PASI); the primary end point was a 75% improvement in PASI. Other efficacy measurements included @entity1 and physician global assessments and quality-of-life measures. RESULTS: After 12 weeks of treatment, 17 (30%) of the 57 etanercept-treated @entity1 and 1 (2%) of the 55 placebo-treated @entity1 had achieved PASI 75%, and after 24 weeks, 32 (56%) of etanercept-treated @entity1 and 3 (5%) of placebo-treated @entity1 had reached this level (P<.001 for both time points). By 24 weeks, @entity1569 was clear or minimal by physician's global assessment in more than 50% of @entity1 who received etanercept. Treatment failure (PASI response <50) occurred in 23% of @entity1 at week 24. All other measures confirmed the efficacy of etanercept. Adverse events were similar among etanercept and placebo groups. CONCLUSION: Etanercept monotherapy provided significant benefit to @entity1 with @entity1569 and had a favorable safety profile.
