英夫利昔单抗生物类似物 CT-P13 治疗炎症性肠病的实际有效性和安全性：一项前瞻性全国观察队列研究（ReFLECT 研究）。

IF 2.6 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Clinics and research in hepatology and gastroenterology Pub Date : 2024-10-22 DOI:10.1016/j.clinre.2024.102483

David Laharie , Yoram Bouhnik , Lucine Vuitton , Amélie Biron , Gaelle Pierron , Yves Brault , Maryse Assing , Amira Bouzidi , Aurélien Amiot , Stephane Nancey

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引用次数: 0

摘要

研究背景ReFLECT 是一项法国前瞻性多中心观察性队列研究，评估了英夫利昔单抗 (IFX) 生物仿制药 CT-P13 在真实世界中的有效性和安全性。在此，我们将介绍针对成人炎症性肠病（IBD）患者的研究结果：我们招募了符合条件的 IBD 患者，他们接受了 CT-P13 的静脉诱导和/或维持治疗；患者要么对 IFX 不敏感（IFX-naive），要么曾接受过 IFX 原研药或另一种 IFX 生物仿制药的治疗（IFX-switched）。主要目标是CT-P13的持续性，在为期两年的随访期间，以时间变量的形式测量CT-P13的持续性。此外还评估了安全性：成年 IBD 患者包括 530 名克罗恩病 (CD) 患者，其中 327 名为 IFX-naive，188 名为 IFX-switched，11 名为其他（即之前接受过 IFX 但在转用 CT-P13 之前接受过其他治疗），4 名数据缺失；溃疡性结肠炎 (UC) 患者 221 名，其中 152 名为 IFX-naive，59 名为 IFX-switched，8 名为其他，2 名数据缺失。随访两年后，CD 和 UC 患者的 CT-P13 持续率分别为 71.7% (95% CI: 66.7, 77.0) 和 63.7% (55.3, 73.3)。IFX转换患者的CT-P13持续率高于IFX免疫患者（CD：83.7% [95% CI：78.0, 89.9] vs 65.7% [58.6, 73.7]；UC：91.2% [81.7, 89.9] vs 65.7% [58.6, 73.7]）：91.2%[81.7，100.0] vs 53.4% [43.0，66.2]）。IFX-naive组（14.7%/21.7%）和IFX-switched组（7.4%/5.1%）停用CT-P13的主要原因是反应消失（CD/UC）。在患者（CD组和UC组）中，分别有51.3%和45.2%的患者报告了≥1次不良事件（AE），分别有13.2%和12.7%的患者报告了严重不良事件：经过两年的随访，超过80%的IFX转换患者维持了静脉注射CT-P13的疗效。CT-P13能有效维持IFX-naive患者的疗效。CT-P13的安全性可接受：试验注册：ClinicalTrials.gov identifier：NCT02925338。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study)

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

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来源期刊

Clinics and research in hepatology and gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

4.30

自引率

3.70%

发文量

198

审稿时长

42 days

期刊介绍： Clinics and Research in Hepatology and Gastroenterology publishes high-quality original research papers in the field of hepatology and gastroenterology. The editors put the accent on rapid communication of new research and clinical developments and so called "hot topic" issues. Following a clear Editorial line, besides original articles and case reports, each issue features editorials, commentaries and reviews. The journal encourages research and discussion between all those involved in the specialty on an international level. All articles are peer reviewed by international experts, the articles in press are online and indexed in the international databases (Current Contents, Pubmed, Scopus, Science Direct). Clinics and Research in Hepatology and Gastroenterology is a subscription journal (with optional open access), which allows you to publish your research without any cost to you (unless you proactively chose the open access option). Your article will be available to all researchers around the globe whose institution has a subscription to the journal.