Efficacy and Safety of Crisaborole by Body Region in Infants with Mild-to-moderate Atopic Dermatitis

Background: Crisaborole ointment, 2%, is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor for treatment of mild-to-moderate atopic dermatitis (AD). This post hoc analysis of the open-label, single-arm, 28-day, phase 4 study CrisADe CARE 1 (NCT03356977) was performed to analyze the efficacy and safety of crisaborole by body region in infants.

Methods: Infants (3 to <24 months) with mild (2) or moderate (3) disease per the Investigator’s Static Global Assessment (ISGA) and treatable percentage of body surface area (%BSA) ≥5 received twice-daily crisaborole for 28 days. Mean percentage change from baseline (%CFB) in Eczema Area and Severity Index (EASI) score and EASI-50 and EASI-75 responses (≥50% and ≥75% improvement from baseline, respectively) by body region (ie, head/neck, upper limb, lower limb, trunk) at day 29 and application site pain (ASP) by body region were determined.

Results: In total, 137 infants were treated with crisaborole. Mean (SD) EASI score at baseline was 11.8 (8.4). Mean (SD) %CFB in EASI scores at day 29 were –52.0 (58.7), –44.3 (60.0), –60.7 (53.5), and –53.2 (47.8) for head/neck, upper limbs, trunk, and lower limb regions, respectively. EASI-50 response rates at day 29 were 53.1%, 56.9%, 66.2%, and 60.0%, respectively. EASI-75 response rates at day 29 were 36.2%, 33.8%, 53.1%, and 39.2%, respectively. Rates of ASP by body region were 1.5%, 1.5%, 0.7%, and 2.9%, respectively. Reported rates of application site discomfort by body region were 1.5%, 0.7%, 0.7%, and 0%, respectively.

Conclusion: Crisaborole was efficacious and safe across all body regions. Rates of ASP and application site discomfort were low and comparable across the 4 body regions.