Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults

Abstract

Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks. We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792). Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus. More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P=.038; AD-302: 31.4% vs 18.0%, P<.001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P=.005; 48.5% vs 29.7%, P<.001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P≤.001). Treatment-related adverse events were infrequent and mild to moderate in severity. Short study duration was a limitation. Crisaborole demonstrated a favorable safety profile and improvement in all measures ofefficacy, including overall disease severity, pruritus, and other signs of AD.