Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 74, Issue 1, Pages 134-142Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2015.09.001
Keywords
apremilast; nail psoriasis; phosphodiesterase 4 inhibitor; psoriasis; scalp psoriasis; systemic therapy
Categories
Funding
- Celgene Corporation
- AbbVie
- Amgen
- Boehringer Ingelheim
- Eli Lilly and Company
- Janssen Pharmaceuticals
- LEO Pharma
- Novartis
- Pfizer
- Merck Sharp Dohme
- Pierre Fabre
- Merck Co Inc
- Sandoz
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Background: In 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. Objective: We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. Methods: A 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. Results: At 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. Limitations: Baseline randomization was not stratified for nail/scalp psoriasis. Conclusion: Apremilast reduces the severity of nail/scalp psoriasis.
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