Médecine

Paramédical

Autres domaines


S'abonner

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

Doi : 10.1016/j.jaad.2015.09.001 
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.

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.
 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.


© 2015  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

  • Contenu

Vol 74 - N° 1

P. 134-142 - janvier 2016 Retour au numéro
Article précédent Article précédent
  • Treatment of recalcitrant granuloma annulare (GA) with adalimumab: A single-center, observational study
  • Michelle S. Min, Mark Lebwohl
| Article suivant Article suivant
  • Skin diseases associated with Agent Orange and other organochlorine exposures
  • Andrew T. Patterson, Benjamin H. Kaffenberger, Richard A. Keller, Dirk M. Elston

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

;

Mon compte


Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.