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

doi:10.1007/s40257-019-00450-w

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

^*Corresponding author for this work

Dermatology

Research output: Contribution to journal › Article › peer-review

33 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 language	English (US)
Pages (from-to)	711-723
Number of pages	13
Journal	American Journal of Clinical Dermatology
Volume	20
Issue number	5
DOIs	https://doi.org/10.1007/s40257-019-00450-w
State	Published - Oct 1 2019

Funding

We thank the study patients, investigators, and investigational sites whose participation made these studies possible. Medical writing and editorial assistance under the guidance of the authors was provided by Madeline L. Pfau, PhD, and Corey Mandel, PhD, of ApotheCom, San Francisco, CA, USA and was funded by Pfizer Inc. in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–4). Valerie D. Callender is an advisor and speaker for Pfizer. Andrew F. Alexis has received grants from Galderma, Novartis, Almirall, RXi Pharmaceuticals, Bristol-Myers Squibb, Celgene, Menlo, and LEO Pharma and consulting fees or honoraria from Pfizer, Novartis, Almirall, Menlo, Trevi, Dermavant, Unilever, Celgene, BiopharmX, Cipla, Beiersdorf, Valeant, Galderma, Sanofi-Genzyme, and LEO Pharma. Andrew F. Alexis has also received writing assistance, medicines, equipment, or administrative support from Pfizer and payment for lectures from Pfizer and LEO Pharma. Linda F. Stein Gold has received grants from Pfizer, LEO Pharma, and Incyte, and payment for lectures from Pfizer and LEO Pharma. Mark G. Lebwohl is an employee of Mount Sinai and has received research funds from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, LEO Pharma, MedImmune/AstraZeneca, Novartis, Pfizer, SCIderm, Valeant, and Vidac Pharma. Mark G. Lebwohl is also a consultant for Allergan, Aqua Pharmaceuticals, Boehringer Ingelheim, LEO Pharma, Menlo, Mitsubishi, Promius, and Verrica. Amy S. Paller has been an investigator for AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Sanofi-Regeneron, and has been a consultant with honoraria for AbbVie, Amgen, Asana BioSciences, Dermavant, Dermira, Galderma, Eli Lilly, Forte, LEO Pharma, Matrisys Bioscience, Menlo, MorphoSys/Galapagos, Novartis, Pfizer, and Sanofi-Regeneron. Seemal R. Desai has received consulting fees or honoraria and payment for lectures from Pfizer. Huaming Tan, William C. Ports, and Michael A. Zielinski are employees and stockholders of Pfizer Inc. Anna M. Tallman was an employee and stockholder of Pfizer Inc. at the time of the analysis and initial manuscript development.

ASJC Scopus subject areas

Dermatology

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10.1007/s40257-019-00450-w

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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

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

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{\textquoteright}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.",

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

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doi = "10.1007/s40257-019-00450-w",

language = "English (US)",

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journal = "American Journal of Clinical Dermatology",

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Callender, VD, Alexis, AF, Stein Gold, LF, Lebwohl, MG, Paller, AS, Desai, SR, Tan, H, Ports, WC, Zielinski, MA & Tallman, AM 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, vol. 20, no. 5, pp. 711-723. https://doi.org/10.1007/s40257-019-00450-w

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 - 2019/10/1

Y1 - 2019/10/1

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.

AB - 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.

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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

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