莱布曲珠单抗联合局部皮质类固醇改善日本中重度特应性皮炎患者的患者报告结果

IF 3.5 4区 医学 Q1 DERMATOLOGY Acta dermato-venereologica Pub Date : 2024-09-09 DOI:10.2340/actadv.v104.34375
Akio Tanaka, Ken Igawa, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Sonia Montmayeur, Norito Katoh
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引用次数: 0

摘要

Lebrikizumab 已在 3 期试验中证明了其疗效:ADvocate1和ADvocate2(作为单一疗法)、ADhere和ADhere-J(与局部皮质类固醇联合使用)。本文评估了日本中重度特应性皮炎患者使用来曲珠单抗联合中低效外用皮质类固醇激素治疗16周后对患者报告结果的影响。符合条件的患者(n = 286)按 2:2:3 随机分配,分别接受安慰剂+外用皮质类固醇激素、每 4 周一次的 250 毫克来曲珠单抗(LEBQ4W+外用皮质类固醇激素,基线剂量为 500 毫克)或每 2 周一次的 250 毫克来曲珠单抗(LEBQ2W+外用皮质类固醇激素,基线剂量和第 2 周剂量为 500 毫克)皮下注射。该研究的所有PRO终点均已达到;与安慰剂联合局部皮质类固醇治疗组相比,来曲珠单抗联合局部皮质类固醇治疗组患者在皮肤疼痛NRS、DLQI、POEM、WPAI-AD和SCORAD量表方面均有统计学意义和临床意义的改善。与安慰剂+外用皮质类固醇相比,莱布曲珠单抗联合外用皮质类固醇可改善日本中重度特应性皮炎患者的患者报告结果。
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Lebrikizumab Combined with Topical Corticosteroids Improves Patient-reported Outcomes in Japanese Patients with Moderate-to-severe Atopic Dermatitis.

Lebrikizumab has previously demonstrated efficacy in Phase 3 trials: ADvocate1 and ADvocate2 (as monotherapy), ADhere, and ADhere-J (in combination with topical corticosteroids). Here, the impact of lebrikizumab combined with low- to mid-potency topical corticosteroids on patient-reported outcomes at 16 weeks in Japanese patients with moderate-to-severe atopic dermatitis is evaluated. Eligible patients (n = 286) were randomized 2:2:3 to receive placebo+ topical corticosteroids, 250 mg lebrikizumab every 4 weeks (LEBQ4W+topical corticosteroids, 500 mg loading dose at baseline), or 250 mg lebrikizumab every 2 weeks (LEBQ2W+ topical corticosteroids, 500 mg loading dose at baseline and Week 2) by subcutaneous injection. All PRO endpoints for the study were met; patients in the lebrikizumab in combination with topical corticosteroids groups demonstrated statistically significant and clinically meaningful improvements compared with placebo in combination with topical corticosteroids in Skin Pain NRS, DLQI, POEM, WPAI-AD, and SCORAD scales. Lebrikizumab combined with topical corticosteroids compared with placebo+topical corticosteroids improved patient-reported outcomes in Japanese patients with moderate-to-severe atopic dermatitis.

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来源期刊
Acta dermato-venereologica
Acta dermato-venereologica 医学-皮肤病学
CiteScore
4.90
自引率
2.80%
发文量
210
审稿时长
6-12 weeks
期刊介绍: Acta Dermato-Venereologica publishes high-quality manuscripts in English in the field of Dermatology and Venereology, dealing with new observations on basic dermatological and venereological research, as well as clinical investigations. Each volume also features a number of Review articles in special areas, as well as short Letters to the Editor to stimulate debate and to disseminate important clinical observations. Acta Dermato-Venereologica has rapid publication times and is amply illustrated with a large number of colour photographs.
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