Khon Kaen University Hospital, Nai Mueang, Mueang Khon Kaen, Khon Kaen, Thailand.
Phramongkutklao Hospital, Ratchathewi, Bangkok, Thailand.
Immunotherapy. 2023 Oct;15(14):1143-1155. doi: 10.2217/imt-2022-0290. Epub 2023 Aug 17.
The infliximab biosimilar CT-P13 was approved in Thailand in 2015. This open-label, multicenter, post-marketing surveillance study evaluated the safety (events of special interest [ESIs]; primary end point) and effectiveness of 46 weeks of CT-P13 treatment according to routine practice in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA), with 1 year follow-up post-treatment. 30 patients were enrolled (16 RA, 8 AS and 6 PsA). Infections were the most frequently reported study drug-related ESIs (2 RA and 2 AS). One patient with RA and one with PsA experienced infusion-related reactions. No cases of tuberculosis, malignancy (as expected, given 1 year follow-up), or drug-induced liver disease were reported. Disease activity improved across indications. CT-P13 was well tolerated and effective across indications.
英夫利昔单抗生物类似药 CT-P13 于 2015 年在泰国获得批准。这项开放性、多中心、上市后监测研究评估了 CT-P13 按照常规治疗方案治疗类风湿关节炎（RA）、强直性脊柱炎（AS）或银屑病关节炎（PsA）患者 46 周的安全性（特别关注事件[ESI]；主要终点）和有效性，并在治疗后进行了 1 年的随访。共纳入 30 名患者（16 名 RA、8 名 AS 和 6 名 PsA）。感染是报告最多的与研究药物相关的 ESI（2 名 RA 和 2 名 AS）。1 名 RA 患者和 1 名 PsA 患者出现了输注相关反应。未报告结核病、恶性肿瘤（考虑到随访 1 年）或药物性肝损伤病例。疾病活动度在各适应症中均得到改善。CT-P13 在各适应症中具有良好的耐受性和有效性。
