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) - 18/12/15
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.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, nail psoriasis, phosphodiesterase 4 inhibitor, psoriasis, scalp psoriasis, systemic therapy
Abbreviations used : BID, ESTEEM, NAPSI, NAPSI-50, PASI, ScPGA, sPGA
Plan
These studies were sponsored by Celgene Corporation. |
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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. |
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Reprints not available from the authors. |
Vol 74 - N° 1
P. 134-142 - janvier 2016 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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