PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis.

IF 4.2 3区医学

Therapeutic Advances in Gastroenterology Pub Date : 2023-01-01 DOI:10.1177/17562848221145654

Yoram Bouhnik, Bruno Fautrel, Laurent Beaugerie, Anne-Laure Pelletier, Christine Martinez-Vinson, Ulrich Freudensprung, Amira Brigui, Janet Addison

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Abstract

Background: Flixabi^TM (SB2) is a biosimilar of the reference infliximab (IFX), Remicade^®. Published evidence on long-term, real-world use of SB2 in patients either IFX naive or transitioned from prior IFX is scarce.

Objectives: We evaluated persistence, effectiveness, and safety of SB2 over 12 months in adults with IBD [Crohn's disease (CD) and ulcerative colitis (UC)], participating in PERFUSE.

Design: PERFUSE is a long-term, non-interventional, multicenter study of patients receiving SB2 at specialist sites across France.

Methods: SB2 treatment was initiated in September 2017, either as first IFX treatment (IFX naive), after transition from treatment with reference IFX (IFX ref) or another IFX biosimilar (IFX bs), or both IFX ref and IFX bs (IFX multiswitch). Outcomes up to Month 12 (±2) include persistence on SB2 (primary outcome measure), SB2 dose, disease status, immunogenicity, and safety.

Results: This final 12-month analysis of patients with IBD includes 569 with CD and 168 with UC. Persistence [95% confidence interval (CI)] at Month 12 was CD: 89% (77.2; 94.9), UC: 78.5% (58.2; 89.8) for IFX naive; CD: 94% (91.0; 96.1), UC: 92.8% (84.8; 96.7) for IFX ref; CD: 91.6% (86.0; 95.0), UC: 94.2% (83.1; 98.1) for IFX bs; and CD 100% (100; 100), UC 100% (100; 100) for IFX multiswitch. In the CD and UC cohorts, disease activity among IFX naive patients declined from baseline to Month 12; with any prior IFX, the proportions of patients in remission at baseline, Month 6, and Month 12 remained unchanged in the UC cohort, and were comparable or higher in the CD cohort. No immunogenicity or safety signals were detected.

Conclusions: Patients with IBD can be initiated on SB2 or transitioned from IFX ref and/or IFX bs to SB2, with no loss of disease control or safety concerns, with >75% of naive and >90% of transitioned patients continuing on SB2 treatment at 12 months.

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PERFUSE:法国一项接受英夫利昔单抗生物类似药SB2的炎症性肠病患者的非介入性研究:一项为期12个月的分析。

背景:FlixabiTM (SB2)是参考药物英夫利昔单抗(IFX) Remicade®的生物仿制药。关于首次IFX或从先前IFX过渡的患者长期、实际使用SB2的公开证据很少。目的:我们评估了参与PERFUSE的成人IBD[克罗恩病(CD)和溃疡性结肠炎(UC)]患者服用SB2超过12个月的持续性、有效性和安全性。PERFUSE是一项长期、非介入性、多中心研究，研究对象是在法国各地的专科医院接受SB2治疗的患者。方法:SB2治疗于2017年9月开始，作为IFX的首次治疗(IFX naive)，在参考IFX (IFX ref)或另一种IFX生物仿制药(IFX bs)治疗过渡后，或IFX ref和IFX bs (IFX multiswitch)治疗。截至第12个月(±2)的结局包括SB2持续治疗(主要结局指标)、SB2剂量、疾病状态、免疫原性和安全性。结果:最后12个月的IBD患者分析包括569例CD和168例UC。第12个月的持续性[95%置信区间(CI)]为CD: 89% (77.2;94.9)， uc: 78.5% (58.2;IFX naive为89.8);Cd: 94% (91.0;96.1)， uc: 92.8% (84.8;96.7) for IFX ref;Cd: 91.6% (86.0;95.0)， uc: 94.2% (83.1;98.1)为IFX bs;CD 100% (100;100)， uc 100% (100;100)用于IFX多路开关。在CD和UC队列中，IFX初始患者的疾病活动性从基线到第12个月下降;对于任何先前的IFX, UC队列患者在基线、第6个月和第12个月的缓解比例保持不变，而CD队列患者的缓解比例相当或更高。未检测到免疫原性或安全性信号。结论:IBD患者可以开始接受SB2治疗或从IFX ref和/或IFX bs过渡到SB2，没有疾病控制或安全问题，>75%的初始患者和>90%的过渡患者在12个月时继续接受SB2治疗。

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来源期刊

Therapeutic Advances in Gastroenterology Medicine-Gastroenterology

自引率

2.40%

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103

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.