Long-term safety of crisaborole ointment, 2%, across racial and ethnic groups
J Am Acad Dermatol
Introduction: Atopic dermatitis (AD), a chronic inflammatory skin disease, is more prevalent in patients who are black, Asian, of multiple races, or of Hispanic ethnicity. AD often requires long-term topical treatment, so it is important to understand the long-term safety profile of topical AD treatments. Crisaborole ointment is a nonsteroidal, phosphodiesterase 4 inhibitor for the treatment of mild to moderate AD. The long-term safety of crisaborole according to race and ethnicity was assessed in a post hoc analysis.
Methods: Patients ≥2 years of age who completed a 28-day phase 3 pivotal study (NCT02118766, NCT02118792), without safety issues that precluded further treatment with crisaborole, 2%, were enrolled in a long-term, open-label, 48-week safety study. Patients were assessed for AD severity every 4 weeks and treated with a 4-week cycle of crisaborole if AD severity was mild or greater (Investigator’s Static Global Assessment ≥2). Treatment-emergent adverse events (TEAEs) reported here included all events with an onset on or after treatment initiation in the phase 3 pivotal studies. Post hoc analysis was by race and ethnicity. Race groups were defined as Asian (A; Asian/native Hawaiian/other Pacific Islanders), black/African American (B), white (W), and other (O; other/American Indian/Alaskan native). Ethnicity groups were defined as Hispanic/Latino (HL) or not Hispanic/Latino (nHL).
Results: The long-term safety study enrolled 517 patients (n [%]: A 29 [5.6]; B 152 [29.4]; W 315 [60.9]; O 21 [4.1]; HL 82 [15.9]; nHL 435 [84.1]). The proportions of patients reporting ≥1 TEAE were, n (%): A 15 (51.7); B 76 (50.0); W 227 (72.1); O 18 (85.7); HL 57 (69.5); nHL 279 (64.1). Percentage of patients reporting treatment-related TEAEs ranged from 7.9% to 23.8% (n [%]: A 3 [10.3]; B 12 [7.9]; W 33 [10.5]; O 5 [23.8]; HL 12 [14.6]; nHL 41 [9.4]). TEAEs resulting in discontinuation of crisaborole treatment were application site dermatitis (n: B 1; nHL 1), application site pain (n: W 1; O 1; nHL 2), dermatitis atopic (n: B 2; W 3; HL 3; nHL 2), and eczema (n: W 1; nHL 1). No patients in the A group discontinued crisaborole treatment because of a TEAE.
Conclusions: In this post hoc analysis, the rates of treatment-related TEAEs and discontinuations due to TEAEs were similar in all groups except the O group, which should be interpreted with caution given the small sample size of the O group.