• J. Am. Acad. Dermatol. · Jan 2016

    Randomized Controlled Trial

    Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2).

    • Phoebe Rich, Melinda Gooderham, Hervé Bachelez, Joana Goncalves, Robert M Day, Rongdean Chen, and Jeffrey Crowley.
    • Oregon Health and Science University, Portland, Oregon. Electronic address: phoeberich@aol.com.
    • J. Am. Acad. Dermatol. 2016 Jan 1; 74 (1): 134-42.

    BackgroundIn the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis.ObjectiveWe sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2.MethodsA total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline.ResultsAt baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: -22.5% versus +6.5% (ESTEEM 1; P < .0001) and -29.0% versus -7.1% (ESTEEM 2; P = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32.LimitationsBaseline randomization was not stratified for nail/scalp psoriasis.ConclusionApremilast reduces the severity of nail/scalp psoriasis.Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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