Lee Chiuping, Takeuchi Masaki, Kawagoe Tatsukata, Nakamura Jutaro, Shibuya Etsuko, Ishihara Mami, Yamada Norihiro, Mizuki Yuki, Meguro Akira, Kirino Yohei, Soejima Yutaro, Hirahara Lisa, Iizuka Yuki, Mizuki Nobuhisa
Department of Ophthalmology and Visual Science, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Department of Stem Cell and Immune Regulation, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Jpn J Ophthalmol. 2025 Apr 30. doi: 10.1007/s10384-025-01206-2.
This study evaluated the effectiveness and safety of the biosimilar infliximab CT-P13 in treating refractory uveitis associated with Behçet's disease.
Retrospective study.
A retrospective analysis of medical records from seven patients was conducted, categorizing them into two groups: those initially treated with CT-P13 (Group 1) and those switched from other tumor necrosis factor inhibitors (Group 2). Data on demographics, treatment duration, ocular inflammatory attacks, visual acuity changes, relapse rates, and adverse events were collected.
Seven patients (mean age: 32.0 ± 17.7 years) with refractory uveitis associated with Behçet's disease were included. Four patients in Group 1 received CT-P13 as their first-line biologic therapy, of whom two (50%) achieved remission. All patients exhibited a significant reduction in relapses in the 6 months before and after CT-P13 treatment (Wilcoxon test, p = 0.031). Three patients in Group 2, switched from original infliximab, maintained remission for an average of 11.0 ± 2.0 months. Overall, 71.4% of patients achieved remission. No significant changes in visual acuity were observed in either group. One adverse event occurred, but no adverse drug reactions were reported.
The biosimilar infliximab CT-P13 appears to be an effective and cost-efficient option for managing refractory uveitis in Behçet's disease. This finding highlights its potential in managing this challenging condition and warrants further investigation in larger patient cohorts.
本研究评估了生物类似药英夫利昔单抗CT-P13治疗白塞病相关难治性葡萄膜炎的有效性和安全性。
回顾性研究。
对7例患者的病历进行回顾性分析,将其分为两组:初始接受CT-P13治疗的患者(第1组)和从其他肿瘤坏死因子抑制剂转换而来的患者(第2组)。收集了人口统计学、治疗持续时间、眼部炎症发作、视力变化、复发率和不良事件的数据。
纳入了7例白塞病相关难治性葡萄膜炎患者(平均年龄:32.0±17.7岁)。第1组的4例患者接受CT-P13作为一线生物治疗,其中2例(50%)实现缓解。所有患者在CT-P13治疗前后6个月内的复发率均显著降低(Wilcoxon检验,p = 0.031)。第2组的3例从原英夫利昔单抗转换而来的患者平均维持缓解11.0±2.0个月。总体而言,71.4%的患者实现缓解。两组患者的视力均未观察到显著变化。发生了1例不良事件,但未报告药物不良反应。
生物类似药英夫利昔单抗CT-P13似乎是治疗白塞病难治性葡萄膜炎的一种有效且经济高效的选择。这一发现凸显了其在管理这一具有挑战性疾病方面的潜力,值得在更大的患者队列中进一步研究。