CT-P10是第一个获批的利妥昔单抗生物仿制药。这项韩国后市场监测研究评估了CT-P10在批准适应症方面的安全性和有效性。这是一项前瞻性、开放式、观察性和4期研究，收集了韩国境内27个中心的日常临床实践数据。在监测期间（2016年11月16日至2020年11月15日），根据处方信息，患者接受了第一次CT-P10治疗，主要用于非何杰金淋巴瘤（NHL）、慢性淋巴细胞白血病（CLL）、类风湿性关节炎（RA）、多发性肉芽肿性血管炎（GPA）或微小血管性肉芽肿（MPA）。对≤1年（NHL/CLL）或≤24周（RA/GPA/MPA）内的安全性（包括不良事件[AE]和不良药物反应[ADR]）和疾病特异性临床反应（根据最佳总体反应[NHL/CLL]、28关节疾病活动评分[RA]或Wegener的肉芽肿性血管炎伯明翰血管炎活动评分[GPA/MPA]）进行了评估。安全人群包括677名患者（604名NHL、16名CLL、42名RA、7名GPA和8名MPA）。68.4%/27.7%的患者（NHL/CLL）、31.0%/14.3%的患者（RA）和86.7%/13.3%的患者（GPA/MPA）报告了不良事件/不良药物反应。严重不良事件和意外不良药物反应没有引起新的安全信号。肺炎是总体最频繁的严重不良药物反应。发现和已知的CT-P10/参比利妥昔单抗安全剖面一致，在NHL/CLL和RA方面表现出高效性。

CT-P10 was the first licensed rituximab biosimilar. This Korean post-marketing surveillance study evaluated CT-P10 safety and effectiveness in approved indications.This prospective, open-label, observational, phase 4 study collected routine clinical practice data across 27 centers in the Republic of Korea. Patients received their first CT-P10 treatment, per prescribing information, for non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) during the surveillance period (16 November 2016-15 November 2020). Safety (including adverse events [AEs] and adverse drug reactions [ADRs]) and disease-specific clinical response (by best overall response [NHL/CLL], Disease Activity Score in 28-joints [RA], or Birmingham Vasculitis Activity Score for Wegener's Granulomatosis [GPA/MPA]) were assessed for ≤1 year (NHL/CLL) or ≤24 weeks (RA/GPA/MPA).The safety population comprised 677 patients (604 NHL, 16 CLL, 42 RA, 7 GPA, 8 MPA). AEs/ADRs were reported for 68.4%/27.7% (NHL/CLL), 31.0%/14.3% (RA), and 86.7%/13.3% (GPA/MPA) of patients. Serious AEs and unexpected ADRs did not raise new safety signals. Pneumonia was the most frequent serious ADR overall. Positive effectiveness outcomes were observed.Findings were consistent with the known CT-P10/reference rituximab safety profile, with high effectiveness observed in NHL/CLL and RA.