Subcutaneous Vedolizumab Treatment in a Real-World Inflammatory Bowel Disease Cohort Switched From Intravenous Vedolizumab: Eighteen-Month Prospective Follow-up Study.

IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY
Crohn's & Colitis 360 Pub Date : 2024-02-26 eCollection Date: 2024-01-01 DOI:10.1093/crocol/otae013
Thea H Wiken, Marte L Høivik, Karoline Anisdahl, Lydia Buer, David J Warren, Nils Bolstad, Milada Hagen, Bjørn A Moum, Asle W Medhus
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引用次数: 0

Abstract

Background: Vedolizumab has since 2021 been available as a subcutaneous formulation. We aimed to assess 18-month drug persistence and possible predictive factors associated with discontinuation, safety, serum drug profile, drug dosing, and disease activity in a real-world cohort of patients with inflammatory bowel disease switched from intravenous to subcutaneous vedolizumab maintenance treatment.

Methods: Eligible patients were switched to subcutaneous vedolizumab and followed for 18 months or until discontinuation of subcutaneous treatment. Data on preferred route of administration, adverse events, drug dosing, serum-vedolizumab, disease activity, fecal calprotectin, and C-reactive protein were collected. Persistence was described using Kaplan-Meier analysis. The impact of clinical and biochemical variables on persistence was analyzed with Cox proportional hazard models.

Results: We included 108 patients, and the estimated 18-month drug persistence was 73.6% (95% CI [64.2-80.1]). Patients in clinical remission at switch were less likely to discontinue SC treatment (HR = 0.34, 95% CI [0.16-0.73], P = .006), and patients favoring intravenous treatment at switch were almost 3 times more likely to discontinue (HR = 2.78, 95% CI [1.31-5.90], P = .008). Four patients discontinued subcutaneous vedolizumab due to injection site reactions. At 18 months, 88% of patients administered subcutaneous vedolizumab with an interval of ≥ 14 days, and serum-vedolizumab was 39.1 mg/L. Disease activity was stable during follow-up.

Conclusions: Three of the four patients remained on subcutaneous vedolizumab after 18 months, a large proportion received treatment at standard dosing intervals, and disease activity remained stable. This indicates that switching from intravenous to subcutaneous vedolizumab treatment is convenient and safe.

从静脉注射维多珠单抗转为皮下注射维多珠单抗治疗真实世界炎症性肠病队列:十八个月前瞻性随访研究。
背景介绍维多珠单抗自 2021 年起开始提供皮下注射制剂。我们旨在评估从静脉注射转为皮下注射维多珠单抗维持治疗的炎症性肠病患者队列中18个月的药物持续性以及与停药、安全性、血清药物谱、药物剂量和疾病活动相关的可能预测因素:将符合条件的患者转为皮下注射维多珠单抗,并随访18个月或直至停止皮下注射治疗。收集有关首选给药途径、不良事件、药物剂量、血清维多珠单抗、疾病活动、粪便钙蛋白和C反应蛋白的数据。采用卡普兰-梅耶尔分析法对持续率进行了描述。临床和生化变量对持续率的影响采用 Cox 比例危险模型进行分析:我们纳入了 108 名患者,估计 18 个月的药物持续率为 73.6%(95% CI [64.2-80.1])。换药时处于临床缓解期的患者中断皮下注射治疗的可能性较低(HR = 0.34,95% CI [0.16-0.73],P = .006),而换药时倾向于静脉注射治疗的患者中断治疗的可能性几乎高出三倍(HR = 2.78,95% CI [1.31-5.90],P = .008)。有四名患者因注射部位反应而停止皮下注射维多珠单抗。18个月时,88%的患者皮下注射维多珠单抗的间隔≥14天,血清维多珠单抗为39.1毫克/升。随访期间疾病活动稳定:18个月后,四名患者中有三人仍在使用皮下注射的维多珠单抗,大部分患者按标准剂量间隔接受治疗,疾病活动保持稳定。这表明,从静脉注射转为皮下注射维多珠单抗治疗既方便又安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Crohn's & Colitis 360
Crohn's & Colitis 360 Medicine-Gastroenterology
CiteScore
2.50
自引率
0.00%
发文量
41
审稿时长
12 weeks
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