Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Crohn's & Colitis 360 Pub Date : 2023-07-25 eCollection Date: 2023-10-01 DOI:10.1093/crocol/otad040
Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas
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Abstract

Background: A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.

Methods: Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.

Results: Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.

Conclusions: Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.

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皮下英夫利昔单抗治疗难治性克罗恩病患者:一种可能的生物better?
背景:一种被批准用于治疗炎症性肠病患者的英夫利昔单抗(IFX-SC)皮下制剂可能比静脉注射英夫利昔单抗提供更好的疗效。方法:难治性克罗恩病(CD, n = 32)患者先前接受至少2种生物制剂治疗失败,接受IFX-SC治疗,并在第0周(W0)至第30周(W30)从基线进行随访。该研究的主要终点是治疗在W30时的持续性,而次要目标包括分析血清英夫利昔单抗谷底水平(TL -IFX),抗IFX抗体(ATIs)的动态,以及IFX- sc治疗期间CD活性的临床、血清和粪便标志物。结果:W30后中期治疗持续率为53%。TL IFX中位数呈快速显著上升趋势,在W30时超过15.5 μg/mL,而ATI中位数水平显著下降。在W0时ati阴性的患者中(n = 15),只有1例在W30时新发ATIs显示IFX免疫原性。在W0时ATI阳性的患者中,17例患者中有10例(58.8%)出现ATI血清从阳性到阴性的转化。在W30继续接受IFX-SC治疗的患者,自W0起,c反应蛋白(P = 0.041)、粪便钙保护蛋白(P = 0.0002)和Harvey-Bradshaw指数(P = 0.0029)显著降低。结论:先前接受过至少2种生物制剂治疗的难治性CD患者,IFX- sc表现出临床相关的改善,其免疫原性潜力低于IFX- iv和高度稳定的TL IFX。
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来源期刊
Crohn's & Colitis 360
Crohn's & Colitis 360 Medicine-Gastroenterology
CiteScore
2.50
自引率
0.00%
发文量
41
审稿时长
12 weeks
期刊最新文献
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