背景：CT-P13是一种英夫利昔单抗生物类似药，在泰国于2015年获得批准。方法：这项开放标签、多中心、后市场监测研究评估了按照常规实践治疗类风湿性关节炎（RA）、强直性脊柱炎（AS）或银屑病性关节炎（PsA）患者的46周CT-P13治疗的安全性（特殊兴趣事件[ESIs]; 主要终点）和有效性，并在治疗后进行了1年的随访。结果：共招募了30名患者（16例RA，8例AS和6例PsA）。感染是研究药物相关的ESIs中最常见的报告事件（2例RA和2例AS）。一名RA患者和一名PsA患者出现了输液相关反应。未报告结核病、恶性肿瘤（符合1年随访预期）或药物性肝病的病例。各项指标的疾病活动表现有所改善。结论：CT-P13在不同适应症下具有良好的耐受性和有效性。

Background: The infliximab biosimilar CT-P13 was approved in Thailand in 2015. Methods: 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. Results: 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. Conclusion: CT-P13 was well tolerated and effective across indications.