英夫利昔单抗皮下注射与静脉注射在真实队列中的持续性：倾向评分匹配的比较分析。

Persistence of subcutaneous versus intravenous infliximab in a real-life cohort: A propensity-score matched comparative analysis.

作者信息

Bothorel L, Laharie D, Poullenot F, Gohier E, Chevrier C, Berger A, Zerbib F, Rivière P

机构信息

Service d'Hépato-gastroentérologie et oncologie digestive, INSERM CIC 1401, Bordeaux University Hospitals, France.

出版信息

Dig Liver Dis. 2025 Jan;57(1):325-332. doi: 10.1016/j.dld.2024.09.015. Epub 2024 Oct 8.

DOI:10.1016/j.dld.2024.09.015

PMID:39379232

Abstract

BACKGROUND

There is limited comparative data on patients with inflammatory bowel disease (IBD) switched from intravenous to subcutaneous infliximab and those continuing intravenously. This study aimed to compare the persistence and tolerance of subcutaneous and intravenous infliximab and the outcomes of patients resuming intravenous infliximab.

METHODS

We conducted a retrospective single-centre cohort study involving IBD patients treated with maintenance intravenous infliximab. The switch to subcutaneous infliximab was offered to patients in clinical remission receiving an intravenous dose ≤ 10 mg kg every ≥ 6 weeks. The switch group was compared to controls remaining on intravenous infliximab due to refusal of the switch.

RESULTS

With a median follow-up of 59 (46-67) weeks, subcutaneous infliximab was discontinued in 28/282 (10 %) patients and intravenous infliximab in 1/78 (1 %) patient (p = 0.01); after propensity score-matching of the two cohorts, persistence rates at 52 weeks were respectively 91 % (95 % CI 84-98) and 100 % (95 % CI 100-100, p = 0.01). Among the 28 who discontinued subcutaneous infliximab, 27 resumed intravenous infliximab, with 4 (1 % of the switch group) who permanently stopped infliximab.

CONCLUSION

Switching from intravenous to subcutaneous infliximab led to a lower treatment persistance. In cases of poor tolerance or relapse under subcutaneous infliximab, resuming intravenous infliximab is effective.

摘要

背景

关于炎症性肠病（IBD）患者从静脉注射英夫利昔单抗转换为皮下注射以及继续静脉注射的比较数据有限。本研究旨在比较皮下注射和静脉注射英夫利昔单抗的持续性和耐受性，以及恢复静脉注射英夫利昔单抗患者的结局。

方法

我们进行了一项回顾性单中心队列研究，纳入接受维持性静脉注射英夫利昔单抗治疗的IBD患者。对于临床缓解且每≥6周接受静脉剂量≤10mg/kg的患者，提供转换为皮下注射英夫利昔单抗的机会。将转换组与因拒绝转换而继续接受静脉注射英夫利昔单抗的对照组进行比较。

结果

中位随访59（46 - 67）周，282例患者中有28例（10%）停用皮下注射英夫利昔单抗，78例患者中有1例（1%）停用静脉注射英夫利昔单抗（p = 0.01）；两组进行倾向得分匹配后，52周时的持续率分别为91%（95%CI 84 - 98）和100%（95%CI 100 - 100，p = 0.01）。在停用皮下注射英夫利昔单抗的28例患者中，27例恢复静脉注射英夫利昔单抗，4例（转换组的1%）永久停用英夫利昔单抗。