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Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).
Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.
Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.
Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.
Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.
Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).
Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.
Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.
Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.
Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.
Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).
Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.
Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.
Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.
Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.