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溃疡性结肠炎患者英夫利昔单抗静脉输注失败后转换为皮下注射英夫利昔单抗的疗效。

Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure.

机构信息

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

Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

出版信息

Gut Liver. 2024 Jul 15;18(4):667-676. doi: 10.5009/gnl230291. Epub 2024 Jun 5.

Abstract

BACKGROUND/AIMS: Studies on elective switching to the subcutaneous (SC) formulation of infliximab revealed comparable efficacy and safety and higher infliximab level than those exhibited by intravenous (IV) infliximab. However, no studies have reported on the effectiveness of SC switching in ulcerative colitis (UC) patients who experienced IV infliximab failure during maintenance treatment.

METHODS

This retrospective study included UC patients who had been switched to SC infliximab because of IV infliximab failure, between January 2021 and January 2023. Group A was defined as having clinically and biochemically active UC (secondary loss of response), and group B consisted of patients with stable symptoms but biochemically active UC.

RESULTS

Twenty-three patients met the inclusion criteria: 15 in group A and eight in group B. The serum infliximab levels significantly increased after SC switching in both groups. The electively switched group also exhibited increased infliximab levels after SC switching. Patients in group A showed improved partial Mayo score with a significant decrease in fecal calprotectin and C-reactive protein after switching. In group B, the fecal calprotectin level significantly decreased without clinical relapse after switching. A high proportion of patients (≥80%) in both groups achieved clinical and/or biochemical responses at the last follow-up. During the follow-up period, only two patients in group A discontinued SC infliximab, and only one complained of severe injection site reaction.

CONCLUSIONS

In UC patients who experience IV infliximab failure during maintenance treatment, switching to SC infliximab may be a promising option because of better efficacy and safety.

摘要

背景/目的:研究表明,与静脉注射(IV)英夫利昔单抗相比,择期转换为皮下(SC)制剂的英夫利昔单抗具有相当的疗效和安全性,且英夫利昔单抗水平更高。然而,尚无研究报道在维持治疗期间经历 IV 英夫利昔单抗治疗失败的溃疡性结肠炎(UC)患者中,SC 转换的有效性。

方法

本回顾性研究纳入了因 IV 英夫利昔单抗治疗失败而转换为 SC 英夫利昔单抗的 UC 患者,时间范围为 2021 年 1 月至 2023 年 1 月。A 组定义为临床和生化表现活跃的 UC(继发无应答),B 组由症状稳定但生化表现活跃的患者组成。

结果

符合纳入标准的患者共有 23 例:A 组 15 例,B 组 8 例。两组患者在 SC 转换后血清英夫利昔单抗水平均显著升高。选择性转换组在 SC 转换后也表现出英夫利昔单抗水平升高。A 组患者在转换后部分 Mayo 评分改善,粪便钙卫蛋白和 C 反应蛋白显著降低。B 组患者在转换后粪便钙卫蛋白水平显著降低,且无临床复发。两组患者在最后一次随访时均有较高比例(≥80%)达到临床和/或生化应答。在随访期间,A 组仅有 2 例患者停止使用 SC 英夫利昔单抗,且仅有 1 例患者抱怨严重注射部位反应。

结论

在维持治疗期间经历 IV 英夫利昔单抗治疗失败的 UC 患者中,转换为 SC 英夫利昔单抗可能是一种有前途的选择,因为其疗效和安全性更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7c0e/11249938/79532d7f46a3/gnl-18-4-667-f1.jpg

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