在英国和爱尔兰接受维多珠单抗治疗的炎症性肠病患者的健康相关生活质量结果：一项52周的观察性研究（OCTAVO）。

Health-related quality of life outcomes among vedolizumab-treated patients with inflammatory bowel disease in the UK and Ireland: a 52-week observational study (OCTAVO).

作者信息

Parkes Gareth, Akbar Ayesha, Beales Ian, Buckley Martin, Creed Tom, Din Said, Plevris Nikolas, Hogan Niamh, Heggs Nicola, Meadowcroft Simon, Wallington Mike, Fraser Aileen

机构信息

Gastroenterology, The Royal London Hospital, London, E1 1FR, UK.

Gastroenterology, St Mark's Hospital, London, HA1 3UJ, UK.

出版信息

J Patient Rep Outcomes. 2025 Jul 1;9(1):80. doi: 10.1186/s41687-025-00846-9.

DOI:10.1186/s41687-025-00846-9

PMID:40591206

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12214154/

Abstract

BACKGROUND

Vedolizumab is a gut-selective, anti-lymphocyte trafficking biologic therapy for inflammatory bowel disease (IBD). Clinical trials have demonstrated the positive impact of vedolizumab on patient quality of life (QoL); however, real-world evidence of its impact is limited. We evaluated vedolizumab impact on QoL of patients with IBD during the first 52 weeks of treatment in real-world practice in the United Kingdom and Ireland.

METHODS

In this prospective observational study, patients with IBD initiated on vedolizumab completed 4 validated IBD-specific QoL questionnaires at baseline and weeks 14, 26, and 52. The primary endpoint was change in mean Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score. Secondary endpoints included changes in mean scores and sub-scores for other QoL questionnaires.

RESULTS

Overall, 61 patients were enrolled, including 22 with Crohn's disease (CD) and 39 with ulcerative colitis (UC). At week 52, the mean change in SIBDQ scores from baseline was statistically significant (+ 12.3 [p = 0.0123] for CD and + 10.8 [p = 0.0037] for UC) and clinically meaningful (considered as a ≥ 10-point change). A significant improvement in mean SIBDQ scores was seen as early as week 14 for both CD and UC cohorts (p = 0.0256 and p = 0.0348, respectively).

CONCLUSIONS

These real-world findings, using multiple validated tools, demonstrate that vedolizumab treatment for IBD is associated with measurable improvements in QoL from baseline.

摘要

背景

维多珠单抗是一种用于治疗炎症性肠病（IBD）的肠道选择性抗淋巴细胞迁移生物疗法。临床试验已证明维多珠单抗对患者生活质量（QoL）有积极影响；然而，其实际影响的真实世界证据有限。我们评估了在英国和爱尔兰的实际临床实践中，维多珠单抗在治疗的前52周对IBD患者生活质量的影响。

方法

在这项前瞻性观察性研究中，开始使用维多珠单抗治疗的IBD患者在基线、第14周、第26周和第52周完成了4份经过验证的IBD特异性生活质量问卷。主要终点是短炎症性肠病问卷（SIBDQ）平均得分的变化。次要终点包括其他生活质量问卷平均得分和子得分的变化。

结果

总体而言，共纳入61例患者，其中22例为克罗恩病（CD）患者，39例为溃疡性结肠炎（UC）患者。在第52周时，SIBDQ得分相对于基线的平均变化具有统计学意义（CD患者为+12.3[p = 0.0123]，UC患者为+10.8[p = 0.0037]），且具有临床意义（定义为变化≥10分）。CD和UC队列在第14周时SIBDQ平均得分就已出现显著改善（分别为p = 0.0256和p = 0.0348）。