泼尼松龙减量对溃疡性结肠炎患者使用英夫利西单抗疗效的影响：回顾性队列数据

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY

BMJ Open Gastroenterology Pub Date : 2024-05-01 DOI:10.1136/bmjgast-2024-001343

Pernille Dige Ovesen, Mohamed Attauabi, Johan F K F Ilvemark, Mads Damsgaard Wewer, David J Warren, Johan Burisch, Rolf A Klaasen, Nils Bolstad, Casper Steenholdt, Jakob Benedict Seidelin

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引用次数: 0

摘要

背景和目的尚不清楚同时使用泼尼松龙对英夫利西单抗治疗的溃疡性结肠炎（UC）患者的临床疗效和安全性的影响。设计、环境、参与者和结果测量在一家三级炎症性肠病（IBD）中心开展了一项回顾性队列研究，包括147名接受英夫利西单抗治疗的UC患者。主要结果是第14周和第52周的无皮质类固醇临床缓解（CFCR）。根据泼尼松龙减量方案对患者进行分组：标准方案（≤5 毫克/周）、快速方案（>5 毫克/周）、直接停药或不使用泼尼松龙。不耐受皮质类固醇的患者和在初次入院时因准备手术（包括结肠切除术）而停用皮质类固醇的患者除外。结果在使用英夫利西单抗的第14周或第52周，泼尼松龙暴露或未暴露与CFCR之间总体上没有关联。与快速疗法或不使用泼尼松龙相比，第14周时C反应蛋白≤5 mg/L的患者比例在标准减量疗法中更高。在亚组分析中，在开始使用英夫利西单抗时接受≥40毫克泼尼松龙的患者中（64.3% vs 26.3%，p=0.04），以及在急性重症UC患者中（66.6% vs 23.5%，p<0.05），与快速减量方案相比，标准减量方案在第14周时的C反应蛋白发生率更高。第52周的数据与此相似。泼尼松龙不会影响英夫利西单抗的谷值水平，但会增加感染率（10/77 vs 2/70，p=0.03），尤其是艰难梭菌感染。结论在疾病负担有限的 UC 患者中，泼尼松龙不会影响英夫利西单抗的疗效。然而，疾病负担加重的患者似乎可从皮质类固醇激素联合疗法中获益。如有合理要求，可提供相关数据。本研究中使用和/或分析的数据集可向通讯作者索取。

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Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort

Background and objective The influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown. Design, setting, participants and outcome measures A retrospective cohort study was performed, including 147 UC patients treated with infliximab at a tertiary inflammatory bowel disease (IBD) centre. Primary outcome was corticosteroid-free clinical remission (CFCR) at week 14 and week 52. Patients were grouped according to prednisolone tapering regimens: standard (≤5 mg/week), fast (>5 mg/week), direct discontinuation or no prednisolone. Patients intolerant to corticosteroids and patients stopping corticosteroids in preparation for surgery including colectomy during their initial admission were excluded. Results There was no overall association between prednisolone exposure or no exposure and CFCR at weeks 14 or 52 of infliximab. The proportion of patients with C reactive protein ≤5 mg/L was higher in the standard tapering at week 14 as compared with faster regimens or no prednisolone. In subgroup analyses, the standard tapering was associated with a higher rate of CFCR at week 14 compared with the fast-tapering regimen in patients receiving ≥40 mg prednisolone at initiation of infliximab (64.3% vs 26.3%, p=0.04) and among patients admitted with acute severe UC (66.6% vs 23.5%, p<0.05). Similar data were seen at week 52. Prednisolone did not affect infliximab trough levels but increased infection rates (10/77 vs 2/70, p=0.03), in particular C. difficile infection. Conclusion In UC patients with limited disease burden, prednisolone did not affect effectiveness of infliximab. However, patients with increased disease burden seem to benefit from corticosteroid combination therapy. Data are available upon reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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来源期刊

BMJ Open Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

2 weeks

期刊介绍： BMJ Open Gastroenterology is an online-only, peer-reviewed, open access gastroenterology journal, dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology. It is the open access companion journal of Gut and is co-owned by the British Society of Gastroenterology. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around continuous publication, publishing research online as soon as the article is ready.