Katoh Norito, Tanaka Akio, Takahashi Hidetoshi, Shimizu Ryosuke, Kataoka Yoko, Torisu-Itakura Hitoe, Morisaki Yoji, Igawa Ken
North Campus, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Curr Med Res Opin. 2025 Jan;41(1):1-12. doi: 10.1080/03007995.2024.2436982. Epub 2024 Dec 13.
To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).
Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.
At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.
Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.
评估在中度至重度特应性皮炎（AD）日本患者中，乐必妥珠单抗联合外用糖皮质激素（TCS）的疗效和安全性。
在日本37个中心进行的3期随机双盲安慰剂对照研究（ADhere-J；NCT04760314），包括16周诱导期（本文报道）和52周维持期。总共286名年龄≥12岁且体重≥40千克的患者通过交互式网络响应系统随机分组，分别接受皮下注射安慰剂、每4周一次（Q4W）250毫克乐必妥珠单抗或每2周一次（Q2W）250毫克乐必妥珠单抗联合TCS治疗（分别为82、81和123名患者）。共同主要终点为在第16周时达到以下情况的患者比例：（1）研究者整体评估（IGA）评分为0或1且较基线改善≥2分；（2）湿疹面积和严重程度指数（EASI）较基线改善≥75%（EASI 75）。
在第16周时，与安慰剂组相比，乐必妥珠单抗Q4W组和Q2W组中达到IGA（0,1）的患者比例显著更高（分别为6.1%对29.1%和33.4%；均P<0.001），达到EASI 75的患者比例也显著更高（分别为13.4%对47.2%和51.2%；均P<0.001）。严重不良事件（AE）在安慰剂组、乐必妥珠单抗Q4W组和Q2W组中的发生率分别为2.4%、0%和0.8%。常见的治疗中出现的AE，包括发热（安慰剂组：15.9%；乐必妥珠单抗Q4W/Q2W组：18.5%/20.3%）、过敏性结膜炎（安慰剂组：
