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Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups.
Am J Clin Dermatol. 2019 Oct; 20(5):711-723.AJ

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.

Authors+Show Affiliations

Howard University College of Medicine, Washington, DC, USA. drcallender@CallenderSkin.com. Callender Dermatology and Cosmetic Center, Glenn Dale, MD, USA. drcallender@CallenderSkin.com.Mount Sinai St. Luke's and Mount Sinai West, New York, NY, USA. Icahn School of Medicine at Mount Sinai, New York, NY, USA.Henry Ford Health System, Detroit, MI, USA.Icahn School of Medicine at Mount Sinai, New York, NY, USA.Northwestern University Feinberg School of Medicine, Chicago, IL, USA.University of Texas Southwestern Medical Center, Dallas, TX, USA. Innovative Dermatology, Plano, TX, USA.Pfizer Inc., Groton, CT, USA.Pfizer Inc., Groton, CT, USA.Pfizer Inc., Collegeville, PA, USA.Pfizer Inc., New York, NY, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31264114

Citation

Callender, Valerie D., et al. "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, vol. 20, no. 5, 2019, pp. 711-723.
Callender VD, Alexis AF, Stein Gold LF, et al. Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups. Am J Clin Dermatol. 2019;20(5):711-723.
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
Callender VD, et al. Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups. Am J Clin Dermatol. 2019;20(5):711-723. PubMed PMID: 31264114.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups. AU - Callender,Valerie D, AU - Alexis,Andrew F, AU - Stein Gold,Linda F, AU - Lebwohl,Mark G, AU - Paller,Amy S, AU - Desai,Seemal R, AU - Tan,Huaming, AU - Ports,William C, AU - Zielinski,Michael A, AU - Tallman,Anna M, PY - 2019/7/3/pubmed PY - 2019/7/3/medline PY - 2019/7/3/entrez SP - 711 EP - 723 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 20 IS - 5 N2 - 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. SN - 1179-1888 UR - https://www.unboundmedicine.com/medline/citation/31264114/Efficacy_and_Safety_of_Crisaborole_Ointment_2_for_the_Treatment_of_Mild_to_Moderate_Atopic_Dermatitis_Across_Racial_and_Ethnic_Groups_ L2 - https://dx.doi.org/10.1007/s40257-019-00450-w DB - PRIME DP - Unbound Medicine ER -
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