Hidemi Nakagawa1, Osamu Nemoto2, Atsuyuki Igarashi3, Hidehisa Saeki4, Manabu Oda5, Kenji Kabashima6, Takeshi Nagata7. 1. Jikei University School of Medicine, Tokyo, Japan. 2. Kojinkai Sapporo Skin Clinic, Hokkaido, Japan. 3. Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan. 4. Department of Dermatology, Nippon Medical School, Tokyo, Japan. 5. Pharmaceutical Division, Japan Tobacco, Tokyo, Japan. 6. Department of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 7. Pharmaceutical Division, Japan Tobacco, Tokyo, Japan. Electronic address: takeshi.nagata@jt.com.
Abstract
BACKGROUND:Topical delgocitinib (JTE-052), a novel Janus kinase inhibitor, had been shown to be clinically effective in adults with atopic dermatitis (AD). However, the efficacy of topical delgocitinib in pediatric patients with AD remained unclear. OBJECTIVE: We sought to evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD. METHODS: In this phase 2 clinical study (JapicCTI-173553) Japanese patients aged 2 through 15 years with AD were randomized in a 1:1:1 ratio to receive 0.25% or 0.5% delgocitinib ointment or vehicle ointment twice daily for 4 weeks. The primary efficacy end point was the percentage change from baseline in the modified Eczema Area and Severity Index score at the end of treatment (EOT). RESULTS: At EOT, modified Eczema Area and Severity Index scores in both delgocitinib groups were significantly reduced compared with that in the vehicle group. The least-squares mean percentage change from baseline was -54.2% in the 0.25% group and -61.8% in the 0.5% group versus -4.8% in the vehicle group (P < .001 for both comparisons). Similarly, all other efficacy parameters, including Investigator's Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group at EOT. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported. CONCLUSIONS:Delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. These study results indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.
RCT Entities:
BACKGROUND: Topical delgocitinib (JTE-052), a novel Janus kinase inhibitor, had been shown to be clinically effective in adults with atopic dermatitis (AD). However, the efficacy of topical delgocitinib in pediatric patients with AD remained unclear. OBJECTIVE: We sought to evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD. METHODS: In this phase 2 clinical study (JapicCTI-173553) Japanese patients aged 2 through 15 years with AD were randomized in a 1:1:1 ratio to receive 0.25% or 0.5% delgocitinib ointment or vehicle ointment twice daily for 4 weeks. The primary efficacy end point was the percentage change from baseline in the modified Eczema Area and Severity Index score at the end of treatment (EOT). RESULTS: At EOT, modified Eczema Area and Severity Index scores in both delgocitinib groups were significantly reduced compared with that in the vehicle group. The least-squares mean percentage change from baseline was -54.2% in the 0.25% group and -61.8% in the 0.5% group versus -4.8% in the vehicle group (P < .001 for both comparisons). Similarly, all other efficacy parameters, including Investigator's Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group at EOT. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported. CONCLUSIONS:Delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. These study results indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.
Authors: Daniela Mikhaylov; Jacob W Glickman; Ester Del Duca; John Nia; Peter Hashim; Giselle K Singer; Alba L Posligua; Aleksandra G Florek; Erin Ibler; Erika L Hagstrom; Yeriel Estrada; Stephanie M Rangel; Maria Colavincenzo; Amy S Paller; Emma Guttman-Yassky Journal: Arch Dermatol Res Date: 2022-03-01 Impact factor: 3.017