• Mark G Lebwohl, Leon Kircik, Kristina Callis Duffin, David Pariser, Michele Hooper, Deborah Wenkert, Elizabeth H Z Thompson, Jun Yang, Greg Kricorian, and John Koo.
• Mount Sinai Medical Center, New York, New York, USA.
• J. Am. Acad. Dermatol. 2013 Sep 1;69(3):385-92.

BackgroundFew clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis.ObjectiveWe 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.MethodsAdults 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).ResultsA 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; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm.LimitationsNo placebo for CP foam was provided in the etanercept arm.ConclusionsAddition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events.Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

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