Long-term safety of Crisaborole Topical Ointment, 2%, in children and adults with mild- to-moderate atopic dermatitis

Abstract

Abstract Atopic dermatitis (AD) is a chronic inflammatory skin disease that often requires long-term topical treatment. Crisaborole Topical Ointment, 2% (Anacor Pharmaceuticals, Inc., Palo Alto, CA), a novel nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor, is currently being investigated for the treatment of AD. Herein we present the long-term safety results of patients ≥2 years of age with mild-to-moderate AD. A multicenter, open-label, long-term, 48-week, extension safety study was conducted in patients (N = 517) who opted to continue treatment after completing a 28-day Phase 3 pivotal study. Patients were assessed for AD severity every 4 weeks and treated with 4-week cycles of crisaborole as needed (Investigator’s Static Global Assessment ≥2 [Mild]). During the open-label extension and the pivotal studies, 65% of patients reported at least 1 treatment-emergent adverse event (TEAE), most of which were mild (51.2%) or moderate (44.6%) in severity and considered unrelated to treatment (93.1%). Treatment-related AEs occurred in 10.2% of patients; the most frequently reported events were atopic dermatitis (3.1%), application site pain (burning/stinging, 2.3%), and application site infection (1.2%). None of the 7 treatment-emergent serious AEs that occurred in the extension study were considered treatment related. During the long-term study, only 9 patients (1.7%) discontinued the study because of TEAEs. No cutaneous adverse reactions such as application site atrophy, telangiectasia, or hypopigmentation were reported. The safety profile of crisaborole was similar across age groups. Crisaborole Topical Ointment, 2%, has a favorable safety profile for the long-term treatment of patients with AD.