Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Dokkyo Medical University, Dokkyo, Japan.
Acta Derm Venereol. 2024 Sep 9;104:adv34375. doi: 10.2340/actadv.v104.34375.
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.
Lebrikizumab 在 3 期临床试验中已显示出疗效:ADvocate1 和 ADvocate2(作为单药治疗)、ADhere 和 ADhere-J(与局部皮质类固醇联合使用)。在此,评估了 lebrikizumab 联合低至中效局部皮质类固醇对中度至重度特应性皮炎日本患者 16 周时患者报告结局的影响。符合条件的患者(n=286)按 2:2:3 比例随机分配接受安慰剂+局部皮质类固醇、每 4 周 250mg lebrikizumab(LEBQ4W+局部皮质类固醇,基线时给予 500mg 负荷剂量)或每 2 周 250mg lebrikizumab(LEBQ2W+局部皮质类固醇,基线和第 2 周给予 500mg 负荷剂量),通过皮下注射给药。研究的所有 PRO 终点均达到;与安慰剂+局部皮质类固醇相比,LEBQ4W+局部皮质类固醇和 LEBQ2W+局部皮质类固醇组的患者在皮肤疼痛 NRS、DLQI、POEM、WPAI-AD 和 SCORAD 量表中,与安慰剂+局部皮质类固醇相比,具有统计学意义和临床意义的改善。与安慰剂+局部皮质类固醇相比,Lebrikizumab 联合局部皮质类固醇改善了日本中度至重度特应性皮炎患者的患者报告结局。