英夫利昔单抗生物类似药CT-P13用于炎性肠病的真实世界有效性和安全性：一项全国性前瞻性观察队列研究（ReFLECT研究）
Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study).
作者信息
Laharie David, Bouhnik Yoram, Vuitton Lucine, Biron Amélie, Pierron Gaelle, Brault Yves, Assing Maryse, Bouzidi Amira, Amiot Aurélien, Nancey Stephane
机构信息
Service de Gastroentérologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, Neuilly sur Seine, France.
出版信息
Clin Res Hepatol Gastroenterol. 2024 Dec;48(10):102483. doi: 10.1016/j.clinre.2024.102483. Epub 2024 Oct 22.
BACKGROUND
ReFLECT was a French, prospective, multicenter, observational cohort study evaluating the effectiveness and safety of the infliximab (IFX) biosimilar CT-P13 in a real-world setting. Here, we describe the results for adults with inflammatory bowel disease (IBD).
METHODS
Eligible patients with IBD were recruited and received intravenous CT-P13 induction and/or maintenance therapy; patients were either naive to IFX (IFX-naive) or previously treated with IFX originator or another IFX biosimilar (IFX-switched). The primary objective was CT-P13 persistence, which was measured as a time-dependent variable during a two-year follow-up period with four prespecified visits. Safety was assessed.
RESULTS
The adult IBD population comprised 530 patients with Crohn's disease (CD), including 327 categorized as IFX-naive, 188 as IFX-switched, 11 as other (i.e., previously received IFX but received another treatment before switching to CT-P13), and 4 with missing data; and 221 patients with ulcerative colitis (UC), including 152 categorized as IFX-naive, 59 as IFX-switched, 8 as other, and 2 with missing data. After two years of follow-up, the rates of CT-P13 persistence were 71.7 % (95 % CI: 66.7, 77.0) and 63.7 % (55.3, 73.3) in patients with CD and UC, respectively. CT-P13 persistence was greater for IFX-switched patients than for IFX-naive patients (CD: 83.7 % [95 % CI: 78.0, 89.9] vs 65.7 % [58.6, 73.7]; UC: 91.2 % [81.7, 100.0] vs 53.4 % [43.0, 66.2]). The main reason for CT-P13 discontinuation was loss of response (CD/UC) in both IFX-naive (14.7 %/21.7 %) and IFX-switched (7.4 %/5.1 %) groups. Among patients (CD and UC, respectively), 51.3 % and 45.2 % reported ≥1 adverse event (AE), and 13.2 % and 12.7 % reported serious AEs, respectively.
CONCLUSION
After two years of follow-up, the effectiveness of intravenous CT-P13 was maintained in >80 % of IFX-switched patients. CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02925338.
背景
ReFLECT是一项法国前瞻性多中心观察性队列研究，旨在评估英夫利昔单抗（IFX）生物类似药CT-P13在实际临床环境中的有效性和安全性。在此，我们描述炎症性肠病（IBD）成人患者的研究结果。
方法
招募符合条件的IBD患者并接受静脉注射CT-P13诱导和/或维持治疗；患者既往未使用过IFX（初治IFX）或曾接受过原研IFX或其他IFX生物类似药治疗（转换IFX）。主要目标是CT-P13的持续使用情况，在为期两年的随访期间通过四次预先设定的访视将其作为时间依赖性变量进行测量。同时评估安全性。
结果
成人IBD患者群体包括530例克罗恩病（CD）患者，其中327例为初治IFX，188例为转换IFX，11例为其他情况（即既往接受过IFX治疗，但在转换为CT-P13之前接受过其他治疗），4例数据缺失；以及221例溃疡性结肠炎（UC）患者，其中152例为初治IFX，59例为转换IFX，8例为其他情况，2例数据缺失。经过两年随访，CD和UC患者中CT-P13持续使用的比例分别为71.7%（95%CI：66.7，77.0）和63.7%（55.3，73.3）。转换IFX的患者CT-P13持续使用情况优于初治IFX患者（CD：83.7%[95%CI：78.0，89.9]对65.7%[58.6，73.7]；UC：91.2%[81.7，100.0]对53.4%[43.0，66.2]）。CT-P13停用的主要原因在初治IFX组（14.7%/21.7%）和转换IFX组（7.4%/5.1%）中均为疗效丧失（CD/UC）。在患者中（分别为CD和UC患者），分别有51.3%和45.2%报告发生≥1次不良事件（AE），分别有13.2%和12.7%报告发生严重AE。
结论
经过两年随访，超过80%的转换IFX患者维持了静脉注射CT-P13的有效性。CT-P13在初治IFX患者中诱导了有效的治疗维持。CT-P13具有可接受的安全性。
试验注册
ClinicalTrials.gov标识符：NCT02925338。
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