288 Once-daily crisaborole as a long-term maintenance treatment in patients with mild-to-moderate atopic dermatitis: A 52-week clinical trial

Abstract Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control despite patient adherence, with safety concerns limiting the long-term use of many therapies. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. Crisaborole has the potential as a long-term maintenance therapy. To assess the long-term efficacy and safety of crisaborole once daily as a maintenance treatment to reduce the incidence of flares in patients who had achieved response with treatment with crisaborole twice daily. CrisADe CONTROL (NCT04040192) was a randomized, double-blind, vehicle-controlled, 52-week, phase 3 study of patients aged ≥ 3 months with mild-to-moderate AD involving ≥ 5% treatable body surface area. In an open-label run-in period, patients received crisaborole twice daily for up to 8 weeks. Patients who achieved success per Investigator’s Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear] with a ≥ 2-grade improvement from baseline) and ≥ 50% reduction from baseline on the Eczema Area and Severity Index during the run-in were randomly assigned to receive blinded crisaborole or vehicle once daily during the 52-week maintenance period. Patients who experienced a flare (ISGA score ≥2) during the maintenance period switched to crisaborole twice daily for up to 12 weeks (assessed every 4 weeks); if the flare resolved (ISGA score ≤ 1), patients resumed their blinded once-daily treatment. Endpoints included flare-free maintenance until the onset of the first flare (primary), the number of days without flare and the number of flares. The incidence of treatment-emergent adverse events was also evaluated. Of 270 randomly assigned patients, 135 were assigned to crisaborole and 135 to a vehicle once daily. The median time of flare-free maintenance was longer for patients treated with crisaborole vs. vehicle (111 vs. 30 days, respectively; P = 0.0034). The mean number of flare-free days was higher for patients treated with crisaborole vs. vehicle (234.0 vs. 199.4, respectively; P = 0.0346). The mean number of flares was lower for patients treated with crisaborole vs. vehicle (0.95 vs. 1.36, respectively; P = 0.0042). Crisaborole was well tolerated, with no unexpected safety findings or new safety signals when used as a maintenance treatment for 52 weeks. Once-daily treatment with crisaborole was effective and well tolerated for long-term maintenance treatment and flare reduction in adult and paediatric patients with mild-to-moderate AD.