Department of Paediatric Rheumatology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
Department of Paediatric Ophthalmology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
Clin Exp Rheumatol. 2021 Jul-Aug;39(4):907-912. doi: 10.55563/clinexprheumatol/r4gnxm. Epub 2021 Feb 9.
Paediatric non-infectious uveitis (NIU) is an important cause of significant long-term complications and blindness in children. Infliximab (IFX) is a chimeric human/murine monoclonal antibody against TNF-α that is effective in NIU resistant to conventional therapies. In this study, we aimed to determine the efficacy and safety of an IFX biosimilar (CT-P13) in paediatric patients with NIU.
This was a non-interventional and retrospective study that included paediatric patients with NIU who received IFX biosimilar CT-P13 treatment between January 2016 and January 2020. Demographic data pertaining to patients and their disease were collected. The efficacy and safety of the IFX biosimilar were evaluated.
Twenty-six patients (44 eyes) were enrolled in this study. The median age (interquartile range) at the diagnosis of uveitis was 9.41 (5-12.3) years. The most common site of involvement was anterior uveitis, and bilateral involvement was more commonly seen in the older age group (p=0.32). The primary diagnosis of 16 patients was juvenile idiopathic arthritis, three had Behçet's disease, six had idiopathic disease and one had sarcoidosis. All patients were treated with CT-P13 (22 patients were biologic-naïve, and four switched from adalimumab). The median follow-up time on IFX was 14 months (range 4-48). Complete recovery was achieved in 95.4% of eyes with active uveitis, while inactive disease was not achieved in two of them. We observed a reduction in the number of flares in all patients during the follow-up period (4.5±2.2 vs. 0.89±1, p=0.01). Treatment-emergent adverse events occurred in 26.9% of patients.
To our knowledge, this is the first study to assess the impact of CT-P13 treatment adherence on disease activity in children with NIU. The IFX biosimilar CT-P13 is remarkably safe and effective for the long-term treatment of paediatric NIU.
儿科非感染性葡萄膜炎（NIU）是儿童发生严重长期并发症和失明的重要原因。英夫利昔单抗（IFX）是一种针对 TNF-α 的嵌合人/鼠单克隆抗体，对常规治疗耐药的 NIU 有效。在本研究中，我们旨在确定 IFX 生物类似药（CT-P13）在 NIU 儿科患者中的疗效和安全性。
这是一项非干预性和回顾性研究，纳入了 2016 年 1 月至 2020 年 1 月期间接受 IFX 生物类似药 CT-P13 治疗的 NIU 儿科患者。收集了患者及其疾病的人口统计学数据。评估了 IFX 生物类似药的疗效和安全性。
本研究纳入了 26 名患者（44 只眼）。葡萄膜炎诊断时的中位年龄（四分位间距）为 9.41（5-12.3）岁。最常见的受累部位为前葡萄膜炎，年龄较大的患者更常见双侧受累（p=0.32）。16 名患者的主要诊断为幼年特发性关节炎，3 名患者为贝切特病，6 名患者为特发性疾病，1 名患者为结节病。所有患者均接受 CT-P13 治疗（22 名患者为生物制剂初治，4 名患者由阿达木单抗转换）。IFX 的中位随访时间为 14 个月（4-48 个月）。活动性葡萄膜炎的 95.4%的眼中达到完全缓解，其中 2 只眼未达到缓解。我们观察到在随访期间所有患者的发作次数减少（4.5±2.2 与 0.89±1，p=0.01）。26.9%的患者出现治疗相关不良事件。
据我们所知，这是第一项评估 CT-P13 治疗依从性对儿童 NIU 疾病活动影响的研究。IFX 生物类似药 CT-P13 长期治疗儿科 NIU 安全有效。
