Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups

Valerie D. Callender, Andrew F. Alexis, Linda F. Stein Gold, Mark G. Lebwohl, Amy S. Paller, Seemal R. Desai, Huaming Tan, William C. Ports, Michael A. Zielinski, Anna M. Tallman

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Background: Atopic dermatitis is highly prevalent in black/African American, Asian, and Hispanic patients, making assessment of these populations in clinical trials important. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. In two pivotal phase III clinical trials in patients aged ≥ 2 years, crisaborole was superior to vehicle in reducing global disease severity. The most common treatment-related adverse event was application site pain. Objective: The objective of this study was to investigate the efficacy and safety of crisaborole according to patient race and ethnicity. Methods: A pooled post hoc analysis by race and ethnicity of the two pivotal trials and a safety extension trial was performed. Race included white or nonwhite (encompassing Asian/native Hawaiian/other Pacific Islander, black/African American, and other/American Indian/Alaskan native); ethnicity included Hispanic/Latino or not Hispanic/Latino. Results: In white, nonwhite, Hispanic/Latino, and not Hispanic/Latino groups at day 29, more crisaborole- than vehicle-treated patients achieved improvements in global disease severity [Investigator’s Static Global Assessment of clear/almost clear with a ≥ 2-grade improvement (white: 33.5% vs. 22.3%, nominal p < 0.001; nonwhite: 30.0% vs. 21.3%, nominal p < 0.05; Hispanic/Latino: 35.4% vs. 18.2%, nominal p < 0.01; not Hispanic/Latino: 31.3% vs. 22.8%, nominal p < 0.01)]. Crisaborole treatment also improved atopic dermatitis signs/symptoms and quality of life. Frequency of crisaborole-related adverse events was 7.1–8.5% in the pivotal trials. Conclusion: Across races and ethnicities, crisaborole demonstrated efficacy for the treatment of mild-to-moderate atopic dermatitis, with a low frequency of treatment-related adverse events.

Original languageEnglish (US)
Pages (from-to)711-723
Number of pages13
JournalAmerican Journal of Clinical Dermatology
Volume20
Issue number5
DOIs
StatePublished - Oct 1 2019

ASJC Scopus subject areas

  • Dermatology

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    Callender, V. D., Alexis, A. F., Stein Gold, L. F., Lebwohl, M. G., Paller, A. S., Desai, S. R., Tan, H., Ports, W. C., Zielinski, M. A., & Tallman, A. M. (2019). Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups. American Journal of Clinical Dermatology, 20(5), 711-723. https://doi.org/10.1007/s40257-019-00450-w