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

• Published in: American journal of clinical dermatology Vol. 20; no. 5; pp. 711 - 723
• Main Authors: Callender, Valerie D., Alexis, Andrew F., Stein Gold, Linda F., Lebwohl, Mark G., Paller, Amy S., Desai, Seemal R., Tan, Huaming, Ports, William C., Zielinski, Michael A., Tallman, Anna M.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01-10-2019; Springer Nature B.V
• Subjects: Administration, Cutaneous; Adolescent; Adult; African Americans; Aged; Boron Compounds - administration & dosage; Boron Compounds - adverse effects; Bridged Bicyclo Compounds, Heterocyclic - administration & dosage; Bridged Bicyclo Compounds, Heterocyclic - adverse effects; Child; Child, Preschool; Clinical trials; Color; Continental Population Groups - statistics & numerical data; Cultural differences; Dermatitis; Dermatitis, Atopic - diagnosis; Dermatitis, Atopic - drug therapy; Dermatitis, Atopic - ethnology; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatology; Eczema; Erythema; Ethnic Groups - statistics & numerical data; Ethnicity; Female; Health Status Disparities; Hispanic Americans; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Minority & ethnic groups; Ointments; Original; Original Research Article; Pain - chemically induced; Pain - diagnosis; Pain - epidemiology; Pain Measurement; Patients; Pediatrics; Pharmacology/Toxicology; Pharmacotherapy; Pruritus; Quality of Life; Race; Severity of Illness Index; Skin; Skin - drug effects; Success; Time Factors; Treatment Outcome; Young Adult
• ISSN: 1175-0561; 1179-1888
• DOI: 10.1007/s40257-019-00450-w

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.