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'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: 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
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 20 Issue 5 Pg. 711-723 (Oct 2019) ISSN: 1179-1888 [Electronic] New Zealand
• PMID: 31264114 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Boron Compounds
• Bridged Bicyclo Compounds, Heterocyclic
• Dermatologic Agents
• Ointments
• crisaborole

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Aged
• Boron Compounds (administration & dosage, adverse effects)
• Bridged Bicyclo Compounds, Heterocyclic (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Dermatitis, Atopic (diagnosis, drug therapy, ethnology)
• Dermatologic Agents (administration & dosage, adverse effects)
• Ethnicity (statistics & numerical data)
• Female
• Health Status Disparities
• Humans
• Male
• Middle Aged
• Ointments
• Pain (chemically induced, diagnosis, epidemiology)
• Pain Measurement
• Quality of Life
• Racial Groups (statistics & numerical data)
• Severity of Illness Index
• Skin (drug effects)
• Time Factors
• Treatment Outcome
• Young Adult