Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis - 21/06/16
, David M. Pariser, MD b, Norman R. Wasel, MD, FRCPC c, Joana Goncalves, MD d, Robert M. Day, PhD d, Rongdean Chen, PhD d, Michael Sebastian, MD eAbstract |
Background |
Difficult-to-treat palmoplantar psoriasis has a disproportionately negative impact on quality of life.
Objective |
We evaluated the efficacy and safety of apremilast in palmoplantar psoriasis.
Methods |
A post hoc analysis of data pooled from phase IIb (PSOR-005) and phase III (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1 and 2) clinical studies was conducted to determine the effect of apremilast 30 mg twice daily versus placebo at week 16 in a subset of patients with moderate to severe plaque psoriasis with active palmoplantar psoriasis (baseline Palmoplantar Psoriasis Physician Global Assessment [PPPGA] score ≥1).
Results |
Significantly more patients taking apremilast with moderate to severe palmoplantar psoriasis (baseline PPPGA score ≥3) achieved PPPGA score 0 (clear) or 1 (almost clear) compared with placebo at week 16 (48% vs 27%; P = .021). At week 16, 46% of the apremilast group with baseline PPPGA score 1 or higher achieved a PPPGA score of 0 versus 25% of the placebo group (P < .001); 59% of the apremilast group had a PPPGA score of 0 or 1 with 1-point or more improvement versus 39% receiving placebo (P < .001).
Limitations |
This post hoc analysis was limited to 16 weeks and did not assess palmoplantar pustules, lesion localization, or surface area involvement.
Conclusion |
Apremilast may be a useful oral treatment option for patients with moderate to severe palmoplantar plaque psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, difficult to treat, ESTEEM, moderate to severe, palmoplantar psoriasis, palms, PSOR-005, soles
Abbreviations used : ESTEEM, IL, m-PPPASI, PASI, PGA, PPPGA
Plan
| Sponsored by Celgene Corporation. The authors received editorial support in the preparation of the manuscript from Kathy Covino, PhD, of Peloton Advantage, LLC, funded by Celgene Corporation. |
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| Disclosure: Dr Bissonnette has received honoraria for participation on advisory boards and/or research grants from AbbVie, Amgen, Celgene Corporation, Eli Lilly, Galderma Laboratories, Incyte, Janssen, Kineta, LEO Pharma US, Merck, Novartis Pharmaceuticals, Pfizer, and Tribute. Dr Pariser or his institution has received grant/research support from Abbott Laboratories, Amgen, Astellas Pharma US, Asubio Pharmaceuticals, Basilea Pharmaceutical, Celgene Corporation, Dow Pharmaceutical Sciences, Eli Lilly, Galderma Laboratories, Graceway Pharmaceuticals, Intendis, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk A/S, Ortho Dermatologics, Photocure ASA, Stiefel Laboratories, and Valeant Pharmaceuticals, and has received other financial support from LEO Pharma US and Pfizer. Dr Wasel has served as an investigator for Celgene Corporation. Drs Goncalves, Day, and Chen are employees of Celgene Corporation. Dr Sebastian has received research grants from Celgene Corporation. |
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| Reprints not available from the authors. |
Vol 75 - N° 1
P. 99-105 - juillet 2016 Retour au numéro
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