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- Title
Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1).
- Authors
Schlessinger, Joel; Shepard, Julie S.; Gower, Richard; Su, John C.; Lynde, Charles; Cha, Amy; Ports, William C.; Purohit, Vivek; Takiya, Liza; Werth, John L.; Zang, Chuanbo; Vlahos, Bonnie
- Abstract
Background: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). Objectives: The aim of this study was to evaluate the safety, effectiveness, and pharmacokinetics (PK) of crisaborole in infants aged 3 to < 24 months with mild-to-moderate AD in an open-label study. Methods: Infants (3 to < 24 months) with Investigator's Static Global Assessment (ISGA) of mild (2) or moderate (3) and percentage of treatable body surface area (%BSA) ≥ 5 received crisaborole twice daily for 28 days; a cohort with moderate AD per ISGA and %BSA ≥ 35 were included in a PK analysis. Endpoints included safety (primary), efficacy, and PK (exploratory). Results: Included were 137 infants total (mean age [SD], 13.6 months [6.42]), with 21 in the PK cohort (12.7 months [6.58]). Treatment-emergent adverse events (TEAEs) were reported for 88 (64.2%) patients (98.9% rated as mild/moderate). TEAEs were considered treatment-related for 22 patients (16.1%); most frequently reported were application site pain (3.6%), application site discomfort (2.9%), and erythema (2.9%). ISGA clear/almost clear with ≥ 2-grade improvement at day 29 was achieved by 30.2% of patients. From baseline to day 29, mean percentage change in Eczema Area and Severity Index score was − 57.5%, and mean change in Patient-Oriented Eczema Measure total score was − 8.5. Crisaborole systemic exposures in infants were characterized and, based on nonlinear regression analysis, were comparable with that in patients aged ≥ 2 years. Conclusions: In this open-label study, crisaborole was well tolerated and effective in infants (3 to < 24 months) with mild-to-moderate AD with systemic exposures similar to patients aged ≥ 2 years. Clinical Trial Registration: NCT03356977.
- Subjects
AUSTRALIA; CANADA; UNITED States; ATOPIC dermatitis; CLINICAL trials; CONFIDENCE intervals; MEDICAL cooperation; OINTMENTS; PATIENT safety; PEDIATRICS; QUESTIONNAIRES; REGRESSION analysis; RESEARCH; RESEARCH funding; TREATMENT effectiveness; PHOSPHODIESTERASE inhibitors; PROPYLENE glycols; DESCRIPTIVE statistics
- Publication
American Journal of Clinical Dermatology, 2020, Vol 21, Issue 2, p275
- ISSN
1175-0561
- Publication type
Article
- DOI
10.1007/s40257-020-00510-6