Subanalysis of Efficacy by Body Region and Sign and Safety by Body Region of Delgocitinib Ointment

Igarashi Atsuyuki, Nakagawa Hidemi

doi:10.3812/jocd.38.898

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Other Title

成人アトピー性皮膚炎患者を対象としたデルゴシチニブ軟膏の部位・徴候別の有効性及び安全性
成人アトピー性皮膚炎患者を対象としたデルゴシチニブ軟膏の部位・徴候別の有効性及び安全性 : 国内第Ⅲ相試験の追加解析
セイジンアトピーセイヒフエンカンジャオタイショウトシタデルゴシチニブナンコウノブイ・チョウコウベツノユウコウセイオヨビアンゼンセイ : コクナイダイ Ⅲ ソウシケンノツイカカイセキ
—a Phase III Study in Adult Patients with Atopic Dermatitis in Japan
〜国内第Ⅲ相試験の追加解析〜

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Abstract

Objective: We investigated a novel Janus kinase inhibitor, 0.5% delgocitinib ointment, in adult patients with atopic dermatitis. The efficacy was evaluated by body region and sign, and the safety by body region. Methods: A Japanese phase III study of delgocitinib ointment, in adult patients with moderate to severe atopic dermatitis, was comprised of 2 parts; part 1 lasted 4 weeks and consisted of a placebo-controlled, double-blind, comparative study (N = 158); part 2 continued over 24 weeks and was an uncontrolled, open-label, continuous administration study (N = 126). The efficacy by body region and sign was analyzed by the Eczema Area and Severity Index (EASI) score in part 1, and the safety by body region was analyzed throughout parts 1 and 2. Results: For all the body regions evaluated, including head and neck, upper extremities, trunk, and lower extremities, EASI score changes by body region were significantly greater in the delgocitinib group than those in the placebo group (all p < 0.0001) in part 1. The change in EASI scores by sign was significantly greater in the delgocitinib group than that in the placebo group for erythema, edema/papulation, excoriation, and lichenification (all p < 0.0001). The incidence of adverse drug reactions was 5 in 5 patients (4.7%) in the delgocitinib group and 2 in 1 patient (1.9%) in the placebo group in part 1, and there was no difference in the incidence of adverse drug reactions by body region in parts 1 and 2. Conclusions: Delgocitinib ointment was effective in moderate to severe atopic dermatitis in adult Japanese patients, irrespective of the body region and sign of the disease. Delgocitinib ointment was well tolerated for up to 28 weeks, regardless of the body region of application.

Journal

Journal of the Japan Organization of Clinical Dermatologists

Journal of the Japan Organization of Clinical Dermatologists 38 (6), 898-905, 2021

Japan Organization of Clinical Dermatologists

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