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炎症性肠病患者从静脉注射维得利珠单抗转为皮下注射维得利珠单抗维持治疗的真实体验。

Real-life experiences of switching from intravenous to subcutaneous vedolizumab maintenance therapy in patients with inflammatory bowel disease.

机构信息

Abdominal Center - Department of Gastroenterology, Helsinki University Hospital and University of Helsinki, Helsinki.

Department of Gastroenterology, University of Turku and Turku University Hospital.

出版信息

Eur J Gastroenterol Hepatol. 2024 Oct 1;36(10):1193-1201. doi: 10.1097/MEG.0000000000002816. Epub 2024 Jul 8.

Abstract

BACKGROUND

A few prospective cohort studies support the safety of switching from intravenous to subcutaneous administration of vedolizumab during maintenance therapy in patients with inflammatory bowel disease. Real-life data on switching after intravenous induction therapy are lacking.

OBJECTIVE

The aim was to obtain real-world data on subcutaneous vedolizumab treatment in patients with inflammatory bowel disease after switching from intravenous vedolizumab induction or maintenance therapy, and to evaluate treatment persistence, safety, and changes in disease activity and serum vedolizumab concentrations.

METHODS

We performed a retrospective registry-based study of inflammatory bowel disease patients who received subcutaneous vedolizumab therapy in two tertiary centres.

RESULTS

Altogether, 103 patients (26 Crohn's disease and 77 ulcerative colitis) switching from intravenous maintenance therapy (group 1) and 44 patients (14 and 30, respectively) switching from intravenous induction therapy (group 2) were included. At 6 months from baseline, 90.3% of the patients in group 1 and 90.9% of the patients in group 2 continued on subcutaneous vedolizumab. After the switch in group 1, disease activity remained stable. In group 2, clinical disease activity decreased significantly in ulcerative colitis patients ( P  = 0.002). The median serum vedolizumab concentration was 34.00 µg/ml during subcutaneous maintenance therapy in group 1, which was significantly higher than the median concentration during intravenous therapy (17.00 µg/ml, P  < 0.001), but remained unchanged in group 2 after the switch (31.50 µg/ml).

CONCLUSION

Based on these data, subcutaneous vedolizumab treatment is well-tolerated and the treatment persistence remains high after switching from intravenous to subcutaneous vedolizumab therapy.

摘要

背景

一些前瞻性队列研究支持在炎症性肠病患者的维持治疗中从静脉给药转换为皮下给药使用维得利珠单抗的安全性。缺乏静脉诱导治疗后转换的真实数据。

目的

旨在获得炎症性肠病患者在静脉用维得利珠单抗诱导或维持治疗后转换为皮下用维得利珠单抗治疗的真实世界数据,并评估治疗的持续性、安全性以及疾病活动度和血清维得利珠单抗浓度的变化。

方法

我们对在两个三级中心接受皮下用维得利珠单抗治疗的炎症性肠病患者进行了一项回顾性基于登记的研究。

结果

共纳入 103 例(26 例克罗恩病和 77 例溃疡性结肠炎)从静脉维持治疗(组 1)和 44 例(分别为 14 例和 30 例)从静脉诱导治疗(组 2)转换的患者。从基线开始的 6 个月时,组 1 的 90.3%和组 2 的 90.9%的患者继续接受皮下用维得利珠单抗治疗。在组 1 中,转换后疾病活动度保持稳定。在组 2 中,溃疡性结肠炎患者的临床疾病活动度显著下降(P = 0.002)。在组 1 中,转换后接受皮下维持治疗时,血清维得利珠单抗浓度中位数为 34.00μg/ml,显著高于静脉治疗时的中位数浓度(17.00μg/ml,P<0.001),但在组 2 转换后保持不变(31.50μg/ml)。

结论

根据这些数据,在从静脉用维得利珠单抗转换为皮下用维得利珠单抗治疗后,皮下用维得利珠单抗治疗是耐受良好的,治疗的持续性仍然很高。

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