Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.
Eichenfield L, Call R, Forsha D, Fowler J, Hebert A, Spellman M, Stein Gold LF, Van Syoc M, Zane L, Tschen E. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.. Journal of the American Academy of Dermatology 2017; 77(4):641-649.
Journal of the American Academy of Dermatology
BACKGROUND: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.
OBJECTIVE: To 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).
METHODS: Global 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.
RESULTS: During 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.
LIMITATIONS: Long-term efficacy was not analyzed.
CONCLUSION: Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.
Medical Subject Headings
Adolescent; Adult; Aged; Boron Compounds; Bridged Bicyclo Compounds, Heterocyclic; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Disease Progression; Female; Humans; Infection; Male; Middle Aged; Ointments; Pain; Phosphodiesterase 4 Inhibitors; Severity of Illness Index; Symptom Flare Up; Young Adult