513 Crisaborole in patients ≥3 months of age with mild-to-moderate atopic dermatitis (AD)
Su JC, Spelman LJ, Eichenfield LF, Stein Gold LF, Cha A, Graham D, Takiya L, Werth JL, Zang C, and Vlahos B. 513 Crisaborole in patients ≥3 months of age with mild-to-moderate atopic dermatitis (AD). Journal of Investigative Dermatology 2020; 140(7):S70.
Journal of Investigative Dermatology
Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. We report the efficacy and safety of crisaborole across age groups in the phase 3 studies AD-301 (NCT02118766) and AD-302 (NCT02118792) and the phase 4 study CrisADe CARE 1 (NCT03356977). Patients aged 3 to <24 months (CARE 1) or ≥2 years (AD-301/AD-302) with mild-to-moderate AD received twice-daily crisaborole (or vehicle in AD-301/AD-302) for 28 days. Safety was the primary endpoint in CARE 1. ISGA success (clear  or almost clear  with a ≥2-grade improvement from baseline) at day 29 was an endpoint in CARE 1 (exploratory) and AD-301/AD-302 (primary). CARE 1 included 137 infants, all treated with crisaborole (mean age, 13.6 months [SD, 6.42]; 64.2% male). In AD-301/AD-302, 1016 patients were treated with crisaborole (46.7% male): 335 were aged 2-6 years; 292, aged 7-11 years; 247, aged 12-17 years; and 142, aged ≥18 years. Rates of treatment-related application site pain (3.6%) and application site discomfort (2.9%) reported in CARE 1 were consistent with the rate of application site pain reported for crisaborole-treated patients in AD-301/AD-302 (4.4%; 2-6 years, 3.6%; 7-11 years, 5.5%; 12-17 years, 4.1%; ≥18 years, 5.0%); most events were mild or moderate. In CARE 1, 30.2% of patients achieved ISGA success at day 29, consistent with that observed for crisaborole-treated patients in AD-301/AD-302 (32.5%; 2-6 years, 30.5%; 7-11 years, 36.6%; 12-17 years, 30.3%; ≥18 years, 29.7%). Based on these studies, crisaborole was well tolerated and effective in patients ≥3 months of age with mild-to-moderate AD.