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

Abstract

Rationale 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%. Methods 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. Results 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 Conclusions 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