Key clinical point: A 52-week long treatment with difamilast ointment was well tolerated and reduced the severity of atopic dermatitis (AD) in Japanese adult and pediatric patients.
Major finding: Overall, 72.3% of adult patients and 89.0% of pediatric patients experienced treatment-emergent adverse events (TEAE) of mostly mild or moderate severity, and only 7.8% of adult patients and 3.5% of pediatric patients discontinued treatment due to TEAE. At week 52, 55.4% of adult patients and 73.5% of pediatric patients achieved ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from a long-term, open-label, phase 3 study including 166 adult (15-70 years) and 200 pediatric (2-14 years) patients with AD who initiated a 52-week treatment with 0.3% or 1% difamilast ointment.
Disclosures: This study was supported by Otsuka Pharmaceutical Co., Ltd. Three authors declared being employees of Otsuka Pharmaceutical, and the other author declared receiving consulting fees, funding, grant support, and honoraria from several sources, including Otsuka Pharmaceutical.
Source: Saeki H et al. Difamilast ointment in Japanese adult and pediatric patients with atopic dermatitis: A phase III, long-term, open-label study. Dermatol Ther (Heidelb). 2022;12:1589-1601 (Jun 18). Doi: 10.1007/s13555-022-00751-9