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Journal of the American Academy of Dermatology
Volume 74, n° 1
pages 134-142 (janvier 2016)
Doi : 10.1016/j.jaad.2015.09.001
accepted : 1 September 2015
Original Articles

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, MD a, , Melinda Gooderham, MD b, Hervé Bachelez, MD, PhD c, Joana Goncalves, MD d, Robert M. Day, PhD d, Rongdean Chen, PhD d, Jeffrey Crowley, MD e
a Oregon Health and Science University, Portland, Oregon 
b SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada 
c Sorbonne Paris Cité Université Paris Diderot, Assistance Publique-Hôpitaux de Paris Hôpital Saint-Louis, Paris, France 
d Celgene Corporation, Warren, New Jersey 
e Bakersfield Dermatology, Bakersfield, California 

Correspondence to: Phoebe Rich, MD, Oregon Dermatology and Research Center, 2565 NW Lovejoy St, Portland, OR 97210.
Abstract
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.

The full text of this article is available in PDF format.

Key words : apremilast, nail psoriasis, phosphodiesterase 4 inhibitor, psoriasis, scalp psoriasis, systemic therapy

Abbreviations used : BID, ESTEEM, NAPSI, NAPSI-50, PASI, ScPGA, sPGA



 These studies were sponsored by Celgene Corporation.
 Disclosures: Dr Bachelez received honoraria/research funding as an advisory board member and/or consultant for AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Merck Sharp & Dohme, and Pierre Fabre. Dr Crowley received honoraria/research funding as a consultant for AbbVie, Amgen, Celgene Corporation, and Eli Lilly and Company; was an investigator for AbbVie, Amgen, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, Merck, and Pfizer; and was a speaker for AbbVie, Amgen, and Celgene Corporation. Drs Goncalves, Day, and Chen are employees of Celgene Corporation. Dr Gooderham received honoraria/research funding as a consultant for Janssen Pharmaceuticals; was a data safety monitoring board member for Kyowa Hakko Kirin Pharma; was an investigator for AbbVie, Amgen, Celgene Corporation, Dermira, Dr Reddy, Eli Lilly and Company, Forward Pharma, Galderma Laboratories, Kyowa Hakko Kirin Pharma, Kythera, LEO Pharma, MedImmune, Merck & Co Inc, Novartis, Pfizer, Regeneron, Roche Laboratories, and Takeda Pharmaceuticals USA Inc; and was a speaker for AbbVie, Actelion, Amgen, Astellas Pharma US Inc, Celgene Corporation, Eli Lilly and Company, Galderma Laboratories, LEO Pharma, and Novartis. Dr Rich received honoraria/research funding as an advisory board member for Eli Lilly and Company and Sandoz; was a consultant for Polichem; and was an investigator for AbbVie, Amgen, Celgene Corporation, Eli Lilly and Company, Janssen, Merck & Co Inc, Novartis, and Pfizer.
 Reprints not available from the authors.



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