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

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Conference Proceeding

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Pediatr Dermatol


Introduction: Atopic dermatitis (AD), a chronic inflammatory skin disease, affects children, adolescents, and adults, often requiring long‐term topical treatment. Two 28‐day, pivotal Phase 3 studies demonstrated that crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 inhibitor, improved disease severity in patients ≥2 years old with mild to moderate AD. To evaluate the long‐term safety of crisaborole ointment across 3 key patient groups (children, adolescents, and adults), patients from the pivotal trials were assessed in a Phase 3, open‐label extension study.

Methods: After completing a 28‐day Phase 3 pivotal study (AD‐301, AD‐302), eligible patients who opted to continue treatment (N = 517) were enrolled in a multicenter, open‐label, 48‐week safety study (AD‐303). AD severity was assessed every 4 weeks and treated as needed (Investigator's Static Global Assessment ≥2 [mild]) with 4‐week cycles of crisaborole. Treatment‐emergent adverse events (TEAEs) were analyzed by age group for children (2–11 years), adolescents (12–17 years), and adults (≥18 years).

Results: During the pivotal studies and extension study, the proportion of patients reporting ≥1 TEAE was similar for children (67.9%) and adolescents (65.1%) and was lower in adults (50.8%). The rate of treatment‐related TEAEs was similar for children (10.4%), adolescents (10.3%), and adults (9.5%). The most frequently reported treatment‐related TEAE by group was atopic dermatitis by children (3.2%), application site pain by adolescents (3.4%), and atopic dermatitis by adults (4.8%). During the extension study, 4 serious AEs were reported in children (infections and infestations: n = 2; nervous system disorders: n = 1; respiratory, thoracic, and mediastinal disorders: n = 1), and 3 were reported in adolescents (immune system disorders: n = 1; psychiatric disorders: n = 2); none were considered related to treatment. No serious AEs were reported in adults. Cutaneous adverse reactions such as application site atrophy and telangiectasia were not reported in any age group.

Conclusions: In patients with mild to moderate AD, the long‐term safety profile of crisaborole ointment was similar for children and adolescents; lower rates of AEs and serious AEs were observed in adults.




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