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
Sunday, March 6, 2016
South Exhibit Hall H (Convention Center)
Mark Boguniewicz, MD FAAAAI, Amy S Paller, Wynnis L Tom, Mark G Lebwohl, Robin L Blumenthal, Robert S Call, Lawrence F Eichenfield, Douglass W Forsha, William C Rees, Eric L Simpson, MD, MCR, Linda F Stein Gold, Andrea L Zaenglein, Matty H Hughes, Lee T Zane, Adelaide A Hebert
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%, P<0.001) with a greater percentage of “almost clear/1” or “clear/0” ISGA scores (study 1: 51.7% vs 40.6%, P=0.005; study 2: 48.5% vs 29.7%, P<0.001). Success in ISGA and improvement in pruritus were achieved earlier with crisaborole than vehicle (P<0.001 vs vehicle). A greater proportion of crisaborole-treated patients achieved success for all clinical signs of AD by Day 29. Treatment-related adverse events were infrequent, transient, and mild/moderate in severity.

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.