Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial - 09/12/21
, Kim Papp, MD, PhD b, c, David Pariser, MD d, Lawrence Green, MD e, Neal Bhatia, MD f, Howard Sofen, MD g, h, Lorne Albrecht, MD b, i, j, Melinda Gooderham, MSc, MD b, k, l, Mindy Chen, MS m, Maria Paris, MD m, Yao Wang, MD m, Kristina Callis Duffin, MD, MS nAbstract |
Background |
Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.
Objective |
To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.
Methods |
Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥ 1 topical psoriasis therapy (NCT03721172). The primary endpoint was the achievement of static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥ 2-point reduction at week 16.
Results |
Five hundred ninety-five patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with a significantly greater static Physician Global Assessment response rate observed at week 16 in the apremilast group compared with the placebo group (21.6% vs 4.1%; P < .0001). All secondary endpoints were met with the achievement of body surface area-75 (33.0% vs 7.4%), body surface area ≤ 3% (61.0% vs 22.9%), ≥ 4-point reduction in Whole Body Itch Numeric Rating Scale (43.2% vs 18.6%), Scalp Physician Global Assessment 0 or 1 and ≥ 2-point reduction (44.0% vs 16.6 %), and changes from baseline in body surface area, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (all P < .0001). The most commonly reported adverse events (≥ 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.
Limitations |
The study lacked an active-comparator arm.
Conclusion |
Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, clinical trial, mild-to-moderate psoriasis, pruritus, quality-of-life, scalp
Abbreviations used : ADVANCE, AE, BSA, BSA-75, CMH, DLQI, ITT, PASI, QOL, sPGA, ScPGA, TEAE, WBI-NRS
Plan
| Funding sources: This study was sponsored by Amgen Inc. Writing support was funded by Amgen Inc and provided by Amy Shaberman, PhD, of Peloton Advantage, LLC, an OPEN Health company, and Mandy Suggitt, Amgen Inc. |
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| IRB approval status: The study was approved by the institutional review board/ethics committee of Advarra, Columbia, Maryland, USA and the Advarra Institutional Review Board, Aurora, Ontario, Canada before commencement and was conducted in compliance with Good Clinical Practice, the International Council for Harmonisation Guideline E6, the Declaration of Helsinki, and applicable regulatory requirements. |
Vol 86 - N° 1
P. 77-85 - janvier 2022 Retour au numéro
Article précédent
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