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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

Amy S Paller, Wynnis L Tom, Mark G Lebwohl, Robin L Blumenthal, Mark Boguniewicz, Robert S Call, Lawrence F Eichenfield, Douglass W Forsha, William C Rees, Eric L Simpson, Mary C Spellman, Linda F Stein Gold, etc.

J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6.

PMID: 27417017

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP906673243 Crisaborole Crisaborole 906673-24-3 Price
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