Long-term safety of crisaborole in children and adults with mild-to-moderate atopic dermatitis
Background: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease. Unfortunately in the last 15 years there has been little advancement in topical therapies, which are associated withpotential safety concerns. To address the need for a safe and targeted long-term treatment, Crisaborole (CrisaboroleTopical Ointment, 2%), a novel nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor, is currently being investigated for the treatment of mild-to-moderate AD. Objectives: To evaluate the long-term safety in patients withmild-to-moderate AD, ≥2 years of age who were included in an open-label extension study. Methods: A multicenter, open-label, 48-week safety study enrolled patients (N = 517) who continued treatment after completing a 28-day Phase 3 pivotal study. Every 4 weeks patients were assessed for AD severity and treated as needed with 4-week cycles of crisa-borole (Investigator's Static Global Assessment ≥2 (Mild)). Safety measures included assessment of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, and clinical laboratory results. Results: During the pivotal studies and the open-label extension study, at least 1 treatment- emergent adverse event (TEAE) was reported by 65%of patients, most of which were considered unrelated to treatment (93.1%) and were mild (51.2%) or moderate (44.6%) in severity. Analysis over time (four 12-week treatment periods) of the severity and frequency of TEAEs was well balanced, demonstrating a favorable safety profile for long-term treatment of crisaborole. Overall, 10.2%of patients reported treatment-related AEs; the most frequently reported events were atopic dermatitis (3.1%), application site pain (2.3%), and application site infection (1.2%). In the extension study, none of the 7 reported treatment-emergent SAEs were considered treatment related. During the extension study only 9 patients (1.7%) discontinued the study because of TEAEs. There were no cutaneous adverse reactions such as hypopigmentation, application site atrophy, or telangiectasia reported. Conclusion: Crisaborole demonstrated a favorable safety profile for the long-term treatment of patients with AD.