Crisaborole ointment, 2%, in patients 3 months of age and older with mild-to-moderate atopic dermatitis (AD)

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Conference Proceeding

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Australas J Dermatol


Introduction: Crisaborole is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. AD-301 (NCT02118766) and AD-302 (NCT02118792) were pivotal phase 3 studies of crisaborole in patients aged ≥ 2 years. CrisADe CARE 1 was a single-arm, openlabel phase 4 study (NCT03356977) of crisaborole in patients aged 3 to < 24 months.

Methods: 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 [0]/almost clear [1] with a ≥ 2-grade improvement from baseline) at day 29 was an exploratory endpoint in CARE 1 and the primary endpoint in AD-301/ AD-302.

Results: CARE 1 included 137 infants, all treated with crisaborole (mean age, 13.6 months [SD, 6.42]). In AD-301/ AD-302, 1016 patients were treated with crisaborole (12.3 years [12.16]). Treatment-emergent AEs were reported for 88 (64.2%) patients in CARE 1 and 297 (29.3%) patients in AD-301/AD-302; 98.8% in CARE 1 and 94.3% in AD-301/AD-302 were mild/moderate. Rates of treatment-related application site pain (3.6%) and application site discomfort (2.9%) in CARE 1 were consistent with the rate of application site pain for crisaborole-treated patients in AD-301/AD-302 (4.4%). In CARE 1, 30.2% and 47.3% of patients achieved ISGA success and ISGA clear/ almost clear at day 29, respectively, consistent with observations for crisaborole-treated patients in AD-301/AD-302 (32.1% and 51.7%).

Conclusions: Based on these studies, crisaborole was well tolerated and effective in patients with mild-to-moderate AD, 3 months of age and older.




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