Pharmacy Department, University Hospital Southampton NHS Foundation Trust [UHS], Southampton, UK.
Faculty of Medicine, University of Southampton, Southampton, UK.
J Crohns Colitis. 2022 Jul 14;16(6):911-921. doi: 10.1093/ecco-jcc/jjab224.
Subcutaneous [SC] vedolizumab presents the opportunity for inflammatory bowel disease [IBD] patients to manage their treatment at home. There are currently no data on the process of transitioning patients established on intravenous [IV] to SC vedolizumab as part of routine clinical care. The aim of this programme is to evaluate the clinical and biochemical outcomes of switching a cohort of IBD patients established on IV vedolizumab to SC, at 12 weeks following the transition.
In all, 178 adult patients were offered the opportunity to transition to SC vedolizumab. Patients who agreed were reviewed prior to switching and at Week 12 [W12] after their first SC dose. Evaluation outcomes included disease activity scores, the IBD-Control Patient-Reported Outcome Measures [PROMs], and faecal calprotectin [FCP]. Reasons for patients declining or accepting transitioning, pharmacokinetics, adverse drug reactions, and risk factors for a poor outcome in SARS-CoV-2 infection were also assessed.
A total of 124 patients agreed to transition, of whom 106 patients had been on IV vedolizumab for at least 4 months. There were no statistically significant differences in disease activity scores or IBD-Control PROMs between baseline and W12. A statistically significant increase in FCP was observed [31 µg/g vs. 47 µg/g; p = 0.008], although this was unlikely to be clinically relevant. The most common adverse drug reaction reported was injection site reactions [15%]. Based on this cohort of patients, an expected reduction of £572,000 per annum is likely to be achieved.
Transitioning patients established on IV vedolizumab to SC appears to be safe and effective, with high patient satisfaction and multiple benefits for the health service.
皮下[SC]维得利珠单抗为炎症性肠病[IBD]患者提供了在家中管理治疗的机会。目前，尚无关于将已接受静脉[IV]维得利珠单抗治疗的患者过渡到 SC 维得利珠单抗的过程的数据，这是常规临床护理的一部分。该方案的目的是评估将一组已接受 IV 维得利珠单抗治疗的 IBD 患者过渡到 SC 后的 12 周的临床和生化结果。
共有 178 名成年患者有机会转为 SC 维得利珠单抗。同意转用的患者在转用前和首次 SC 剂量后 12 周[W12]进行了回顾。评估结果包括疾病活动评分、IBD 控制患者报告结局[PROM]和粪便钙卫蛋白[FCP]。还评估了患者拒绝或接受过渡的原因、药代动力学、药物不良反应以及 SARS-CoV-2 感染不良结局的风险因素。
共有 124 名患者同意转用，其中 106 名患者已接受 IV 维得利珠单抗治疗至少 4 个月。在基线和 W12 之间，疾病活动评分或 IBD 控制 PROM 没有统计学上的显著差异。FCP 显著增加[31 µg/g 比 47 µg/g；p = 0.008]，尽管这可能在临床上并不相关。报告的最常见药物不良反应是注射部位反应[15%]。根据这组患者，预计每年可节省 572,000 英镑。
将已接受 IV 维得利珠单抗治疗的患者过渡到 SC 似乎是安全有效的，患者满意度高，对医疗服务有多种益处。
