Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults - 17/08/16
, Wynnis L. Tom, MD b, c, Mark G. Lebwohl, MD d, Robin L. Blumenthal, PhD e, Mark Boguniewicz, MD f, g, Robert S. Call, MD h, Lawrence F. Eichenfield, MD b, c, Douglass W. Forsha, MD i, William C. Rees, MD j, Eric L. Simpson, MD k, Mary C. Spellman, MD e, Linda F. Stein Gold, MD l, Andrea L. Zaenglein, MD m, Matilda H. Hughes, CCRA e, Lee T. Zane, MD e, Adelaide A. Hebert, MD nAbstract |
Background |
Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.
Objective |
We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).
Methods |
Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.
Results |
More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity.
Limitations |
Short study duration was a limitation.
Conclusions |
Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, crisaborole ointment, eczema, phosphodiesterase 4, pruritus, topical therapy
Abbreviations used : AD, AE, ISGA, MedDRA, PDE4, TCI, TCS, TEAE
Plan
| This study was sponsored by Anacor Pharmaceuticals which was acquired by Pfizer Inc on June 24, 2016. |
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| Disclosure: Anacor Pharmaceuticals, Inc, supplied grants to the institutions of Drs Tom, Lebwohl, Boguniewicz, Call, Simpson, Stein Gold, Zaenglein, and Hebert to conduct the studies. Drs Paller, Eichenfield, Simpson, and Spellman received consulting fees from Anacor Pharmaceuticals, Inc, and Drs Forsha, Zaenglein, Hebert, and Stein Gold received advisory board honoraria. The institution of Dr Tom received funding from Otsuka Inc and Regeneron Inc to conduct clinical trials. The institution of Dr Simpson received funding from Merck Inc, Sanofi-Regeneron, Chugai, Amgen, Celgene, MedImmune, Roche/Genentech, Dermira, and Tioga to conduct clinical trials. Dr Simpson received consultant fees from Sanofi-Regeneron, Galderma, MedImmune, Roche/Genentech, Pfizer, Valeant Pharmaceuticals, and Celgene. Dr Stein Gold received advisory board and speaker honoraria from Celgene, and her institution received funding from Celgene and Otsuka Inc to conduct clinical trials. Dr Lebwohl received investigator and/or consulting funds from AbGenomics, Amgen, Boehringer Ingelheim, Celgene, Ferndale, Lilly, Janssen Biotech, Kadmon, LEO Pharmaceuticals, MedImmune, Novartis, Pfizer, Sun Pharmaceuticals, and Valeant. Dr Forsha received advisory board honoraria from Cipher Pharmaceuticals and Valeant Pharmaceuticals. The institution of Dr Hebert received funding from Galderma, Celgene, Amgen, and Merz to conduct clinical trials. Drs Blumenthal and Zane and Ms Hughes are employees and/or stockholders of Anacor Pharmaceuticals, Inc. Dr Rees has no conflicts of interest to declare. |
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| Supplementary figures and tables as well as a list of participating study sites and investigators are available at www.jaad.org/. |
Vol 75 - N° 3
P. 494 - septembre 2016 Retour au numéro
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