静脉维持治疗后炎症性肠病缓解期和非缓解期患者皮下注射英夫利昔单抗转换治疗的疗效比较：一项多中心队列研究的1年结果

Comparative efficacy of subcutaneous infliximab switching in remission and non-remission patients with inflammatory bowel disease after intravenous maintenance: 1-year outcome from a multicentre cohort study.

作者信息

Bae June Hwa, Lee Yoo Jin, Park Jung-Bin, Baek Ji Eun, Hong Seung Wook, Park Sang Hyoung, Yang Dong-Hoon, Ye Byong Duk, Byeon Jeong-Sik, Myung Seung-Jae, Yang Suk-Kyun, Kim Kyeong Ok, Jang Byung Ik, Kim Eun Soo, Jo Hyeong Ho, Kim Eun Young, Hwang Sung Wook

机构信息

Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South Korea.

出版信息

Therap Adv Gastroenterol. 2025 Apr 23;18:17562848251333516. doi: 10.1177/17562848251333516. eCollection 2025.

DOI:10.1177/17562848251333516

PMID:40297201

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12035300/

Abstract

BACKGROUND

Elective switching from intravenous (IV) to subcutaneous (SC) infliximab (IFX) has shown efficacy in patients with inflammatory bowel disease (IBD). However, long-term outcomes for patients not in remission remain unclear.

OBJECTIVES

We evaluated the effectiveness of SC IFX switching in both remission and non-remission patients.

DESIGN

This study was a retrospective multicentre study conducted across five tertiary hospitals in Korea.

METHODS

Patients with IBD who switched to SC IFX between January 2021 and January 2023 were included. Clinical remission was defined as a Crohn's Disease Activity Index of <150 or a partial Mayo score of <2. Biochemical remission was defined as faecal calprotectin of <250 µg/g and C-reactive protein of <0.5 mg/dL. We investigated the treatment persistence rate of SC IFX and trends in pharmacokinetics, clinical indices and biomarkers over 1 year of follow-up, analysing the data based on the baseline remission state.

RESULTS

Among 127 patients included, 90 (70.9%) were in clinical remission, and 37 (29.1%) were not at the time of switching. The one-year treatment persistence rate was 92.1%, with no significant difference between the clinical remission and non-remission groups ( = 0.139). Persistence was also unaffected by baseline biochemical remission status. IFX pharmacokinetics and biomarkers improved significantly in both clinical groups over 12 months ( < 0.005). Disease activity indices remained stable in the remission group and decreased in the non-remission group after switching. Previous biologics exposure was the only significant predictor of treatment persistence (hazard ratio, 5.634; 95% confidence interval, 1.357-23.384; = 0.017). Adverse events related to SC IFX occurred in 15.7% of patients. The optimal SC IFX cutoff levels associated with clinical and biochemical remission were 11 and 17 μg/mL, respectively.

CONCLUSION

Switching from IV to SC IFX during maintenance therapy demonstrated high treatment persistence and safety, irrespective of clinical and biochemical remission status.

摘要

背景

对于炎症性肠病（IBD）患者，择期从静脉注射（IV）英夫利昔单抗（IFX）转换为皮下注射（SC）英夫利昔单抗已显示出疗效。然而，未缓解患者的长期预后仍不明确。

目的

我们评估了SC英夫利昔单抗转换对缓解期和非缓解期患者的有效性。

设计

本研究是一项在韩国五家三级医院进行的回顾性多中心研究。

方法

纳入2021年1月至2023年1月期间转换为SC英夫利昔单抗的IBD患者。临床缓解定义为克罗恩病活动指数<150或梅奥部分评分<2。生化缓解定义为粪便钙卫蛋白<250μg/g且C反应蛋白<0.5mg/dL。我们调查了SC英夫利昔单抗的治疗持续率以及随访1年期间的药代动力学、临床指标和生物标志物趋势，并根据基线缓解状态分析数据。

结果

在纳入的127例患者中，90例（70.9%）在转换时处于临床缓解状态，37例（29.1%）未处于临床缓解状态。一年治疗持续率为92.1%，临床缓解组和非缓解组之间无显著差异（P = 0.139）。持续率也不受基线生化缓解状态的影响。在12个月内，两组患者的英夫利昔单抗药代动力学和生物标志物均有显著改善（P < 0.005）。转换后，缓解组的疾病活动指数保持稳定，而非缓解组的疾病活动指数下降。既往生物制剂暴露是治疗持续率的唯一显著预测因素（风险比，5.634；95%置信区间，1.357 - 23.384；P = 0.017）。15.7%的患者发生了与SC英夫利昔单抗相关的不良事件。与临床和生化缓解相关的最佳SC英夫利昔单抗临界水平分别为11μg/mL和17μg/mL。