Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis

• Published in: Journal of the American Academy of Dermatology Vol. 77; no. 4; pp. 641 - 649.e5
• Main Authors: Eichenfield, Lawrence F., Call, Robert S., Forsha, Douglass W., Fowler, Joseph, Hebert, Adelaide A., Spellman, Mary, Stein Gold, Linda F., Van Syoc, Merrie, Zane, Lee T., Tschen, Eduardo
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-10-2017
• Subjects: Adolescent; Adult; Aged; atopic dermatitis; Boron Compounds - adverse effects; Bridged Bicyclo Compounds, Heterocyclic - adverse effects; Child; Child, Preschool; crisaborole; Dermatitis, Atopic - chemically induced; Dermatitis, Atopic - drug therapy; Dermatologic Agents - adverse effects; Disease Progression; eczema; Female; Humans; Infection - chemically induced; long-term safety; Male; Middle Aged; ointment; Ointments; Pain - chemically induced; PDE4; Phosphodiesterase 4 Inhibitors - adverse effects; phosphodiesterase-4; Severity of Illness Index; Symptom Flare Up; topical treatment; Young Adult; AD; AE; ointment; TCS; PDE4; phosphodiesterase-4; ISGA; atopic dermatitis; crisaborole; TEAE; SAE; eczema; TCI; topical treatment; long-term safety
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2017.06.010

Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.
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).
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.
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.
Long-term efficacy was not analyzed.
Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.