학술논문

Efficacy and safety of tralokinumab monotherapy and combination therapy with topical corticosteroids in Japanese adults with moderate-to-severe atopic dermatitis / 中等症から重症の日本人成人アトピー性皮膚炎患者におけるトラロキヌマブの単独療法およびステロイド外用薬併用療法の有効性と安全性の検討
Document Type
Journal Article
Source
日本臨床皮膚科医会雑誌 / Journal of the Japan Organization of Clinical Dermatologists. 2023, 40(1):59
Subject
IL-13
atopic dermatitis
efficacy
safety
tralokinumab
アトピー性皮膚炎
インターロイキン-13
トラロキヌマブ
安全性
有効性
Language
Japanese
ISSN
1349-7758
1882-272X
Abstract
Tralokinumab, a fully human monoclonal antibody, specifically binds to interleukin (IL)-13 of the type 2 cytokines involved in the pathogenesis and development of atopic dermatitis (AD) and inhibits IL-13 mediated signaling. It is approved for treating moderate-to-severe AD in several countries. The efficacy and safety of tralokinumab in moderate-to-severe adult AD patients were evaluated for Japanese subgroup of ECZTRA 1, a global clinical study of tralokinumab monotherapy, and ECZTRA 8, for which the study design was the same as that of a global clinical study (ECZTRA 3) of combination therapy with topical corticosteroids (TCS). Tralokinumab monotherapy and combination therapy with TCS in the Japanese cohort showed safety results consistent with both global clinical studies. Tralokinumab improved the signs and symptoms of AD in Japanese patients. However, efficacy results were not highly similar to those of the two global clinical studies, likely affected by the severity of illness at baseline, frequency of rescue therapy, and the amount of TCS used in ECZTRA 8. Long-term treatment up to 68 weeks was well tolerated in ECZTRA 1. These findings suggest that tralokinumab will be a valuable therapeutic option in adult Japanese patients with moderate-to-severe AD.