IBD缓解期患者从静脉注射转为皮下注射英夫利昔单抗1年后的持续性和安全性。

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Nicolas Mathieu, Marianne Hupé, Frédéric Heluwaert, Pauline Rivière, Xavier Hébuterne, Antoine Chupin, Vered Abitbol, Guillaume Bouguen, Lucine Vuitton, Jean-Marc Gornet, Céline Montuclard, Stéphane Nancey, Guillaume Cadiot, Pauline Wils, Cyrielle Gilletta, Astrid de Maissin, Romain Altwegg, Elise Chanteloup, Laurianne Plastaras, Philippe Ah Soune, Arnaud Bourreille, Carmen Stefanescu, Philippe Seksik, Marion Simon, Mathieu Uzzan, Pierre Andrau, Cléa Rouillon, Yves Arondel, Anthony Buisson, Laurent Peyrin-Biroulet, Bassirou Mboup, Eric Vicaut, David Laharie
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引用次数: 0

摘要

背景和目的:关于炎症性肠病(IBD)从静脉注射(IV-IFX)切换到皮下英夫利昔单抗(SC-IFX)后演变的真实数据是必要的。这项前瞻性多中心队列研究的目的是描述从IV-IFX转换为SC-IFX后的持久性、有效性和耐受性。方法:在IV-IFX治疗中无类固醇临床缓解至少6个月的IBD患者,在转入SC-IFX治疗时被纳入前瞻性法国国家队列。在患者入组时和12周、24周和48周时对患者进行评估。主要终点是SC-IFX在W48时的持续性。次要终点包括W48时无类固醇临床缓解,IV-IFX切换率,以及研究期间英夫利昔单抗水平的演变。结果:纳入的426例患者中,72.4%为克罗恩病(CD), 27.5%为溃疡性结肠炎(UC);45.1%的女性;中位年龄37岁[29-50]岁;CD患者的中位病程为12年,UC患者为13年),56%的患者接受IV-IFX标准剂量(5mg/kg, 8周),16%的患者在基线时接受免疫调节剂药物联合治疗。在W48时,SC-IFX持续性为95.4% (95%CI, 93.3-97.5), 86.9%的患者无类固醇临床缓解。结论:在这个大型多中心前瞻性队列中,超过95%的IBD患者从IV-IFX转入缓解期,持续使用SC-IFX一年,证实了SC-IFX的优异疗效和耐受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PErsistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission.

Background and aims: Real-life data regarding inflammatory bowel disease (IBD) evolution after switch from intravenous infliximab (IV-IFX) to subcutaneous infliximab (SC-IFX) is necessary. The aim of this prospective multicenter cohort study was to describe the persistence, effectiveness and tolerance of SC-IFX after switch from IV-IFX.

Methods: IBD patients in steroid-free clinical remission for at least 6 months on IV-IFX were enrolled in a prospective national French cohort when they switched to SC-IFX. Patients were assessed at inclusion and at weeks 12, 24, and 48. The primary endpoint was the persistence of SC-IFX at week 48. Secondary endpoints comprised steroid-free clinical remission at week 48, IV-IFX switch-back rate, and evolution of infliximab levels during the study period.

Results: Among the 426 patients included (72.4% with Crohn's disease , 27.5% with ulcerative colitis; 45.1% female; median age 37 [interquartile range, 29-50] years; median disease duration of 12 years in Crohn's disease, 13 years in ulcerative colitis), 56% were on IV-IFX standard dosing (5 mg/kg 8-weekly) and 16% received combination therapy with an immunomodulator drug at baseline. At week 48, SC-IFX persistence was 95.4% (95% confidence interval, 93.3%-97.5%) and 86.9% of patients were on steroid-free clinical remission. Mean infliximab levels were 8.0 μg/mL at inclusion and 18.0 μg/mL at week 48 (P < .0001). Among the 19 (4.5%) patients who stopped SC-IFX, 6 (1.4%) switched back to IV-IFX. There were 222 adverse events reported in 42.4% of patients, and 12 led to treatment discontinuation, including 6 (1.4%) severe adverse events.

Conclusions: In this large multicenter prospective cohort, persistence at 1 year of SC-IFX was more than 95% of IBD patients switched in remission from IV-IFX, confirming excellent effectiveness and tolerance of SC-IFX.

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来源期刊
CiteScore
16.90
自引率
4.80%
发文量
903
审稿时长
22 days
期刊介绍: Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
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