Long-term safety of crisaborole topical ointment, 2%, in atopic dermatitis
J Invest Dermatol
Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease. Crisaborole Topical Ointment, 2%, 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 from a multicenter, open-label, 48-week safety study on patients (N = 517) ≥2 years of age with mild-to-moderate AD who continued 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%). Analysis of the frequency and severity of TEAEs over time (four 12-week treatment periods) was well balanced, indicating a favorable safety profile for long-term treatment of crisaborole. Overall, treatment-related AEs occurred in 10.2% of patients; the most frequently reported events were atopic dermatitis (3.1%), application site pain (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. Crisaborole Topical Ointment, 2%, has a favorable safety profile for the long-term treatment of patients with AD.
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