We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis.
Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10 % were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks).
A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75 % improvement in PASI score (primary end point, 65.2 % vs 48.3 % in the etanercept + CP vs etanercept arms, respectively;
No placebo for CP foam was provided in the etanercept arm.
Addition of CP to etanercept yielded increased efficacy compared with etanercept alone?at?week 12 without an increase in treatment-related adverse events.