Efficacy and Safety of Crisaborole Topical Ointment, 2%, a Novel, Nonsteroidal, Topical, Anti-Inflammatory, Phosphodiesterase Inhibitor in 2 Phase 3 Studies in Children and Adults with Mild-to-Moderate Atopic Dermatitis
Boguniewicz M, Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Herbert AA. Efficacy and Safety of Crisaborole Topical Ointment, 2%, a Novel, Nonsteroidal, Topical, Anti-Inflammatory, Phosphodiesterase Inhibitor in 2 Phase 3 Studies in Children and Adults with Mild-to-Moderate Atopic Dermatitis. Journal of Allergy and Clinical Immunology 2016; 137(2):AB397-AB397.
Journal of Allergy and Clinical Immunology
Phosphodiesterase 4 (PDE4) enzyme is overexpressed in inflammatory cells of patients with atopic dermatitis (AD); this leads to disease exacerbation. Here, we present safety and efficacy from 2 multicenter, double-blind, vehicle-controlled phase 3 studies of identical design in patients with mild-to-moderate AD (NCT02118766 and NCT02118792) treated with the novel, nonsteroidal, topical, anti-inflammatory investigational PDE4 inhibitor Crisaborole Topical Ointment, 2%.
Patients ≥2 years old with mild-to-moderate AD were randomized 2:1 to receive crisaborole or vehicle twice daily with evaluation on Days 8, 15, 22, and 29. Primary and secondary efficacy endpoints analyzed AD disease severity with the Investigator’s Static Global Assessment (ISGA). Supportive efficacy endpoints examined time to improvement in pruritus, severity of pruritus, and signs of AD.
Studies 1 and 2 enrolled 503:256 and 513:250 crisaborole/vehicle patients, respectively. At Day 29, more crisaborole-treated patients achieved ISGA success than those treated with vehicle (study 1: 32.8% vs 25.4%, P=0.038; study 2: 31.4% vs 18.0%, PP=0.005; study 2: 48.5% vs 29.7%, PP
Two Phase 3 studies demonstrate that Crisaborole Topical Ointment, 2%, represents a novel, safe, and efficacious treatment for children and adults with mild-to-moderate AD.