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.

Autor: Paller AS; Northwestern University, Feinberg School of Medicine, Chicago, Illinois. Electronic address: APaller@nm.org., Tom WL; Rady Children's Hospital-San Diego, San Diego, California; University of California, San Diego, La Jolla, California., Lebwohl MG; Icahn School of Medicine at Mount Sinai, New York, New York., Blumenthal RL; Anacor Pharmaceuticals, Inc, Palo Alto, California., Boguniewicz M; National Jewish Health, Denver, Colorado; University of Colorado School of Medicine, Denver, Colorado., Call RS; Clinical Research Partners, Richmond, Virginia., Eichenfield LF; Rady Children's Hospital-San Diego, San Diego, California; University of California, San Diego, La Jolla, California., Forsha DW; Jordan Valley Dermatology and Research Center, West Jordan, Utah., Rees WC; Pi-Coor Clinical Research, Burke, Virginia., Simpson EL; Oregon Health and Science University, Portland, Oregon., Spellman MC; Anacor Pharmaceuticals, Inc, Palo Alto, California., Stein Gold LF; Henry Ford Health System, Detroit, Michigan., Zaenglein AL; Pennsylvania State University, Hershey, Pennsylvania., Hughes MH; Anacor Pharmaceuticals, Inc, Palo Alto, California., Zane LT; Anacor Pharmaceuticals, Inc, Palo Alto, California., Hebert AA; University of Texas Health Science Center Houston, Houston, Texas.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2016 Sep; Vol. 75 (3), pp. 494-503.e6. Date of Electronic Publication: 2016 Jul 11.
DOI: 10.1016/j.jaad.2016.05.046
Abstrakt: 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.
(Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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