• Lawrence F Eichenfield, Robert S Call, Douglass W Forsha, Joseph Fowler, Adelaide A Hebert, Mary Spellman, Linda F Stein Gold, Merrie Van Syoc, Lee T Zane, and Eduardo Tschen.
• Division of Pediatric Dermatology, Rady Children's Hospital, San Diego, California; Departments of Dermatology and Pediatrics, University of California, San Diego, California. Electronic address: leichenfield@rchsd.org.
• J. Am. Acad. Dermatol. 2017 Oct 1; 77 (4): 641-649.e5.

BackgroundLong-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.ObjectiveTo assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302).MethodsGlobal disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed.ResultsDuring the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs.LimitationsLong-term efficacy was not analyzed.ConclusionCrisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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