维多珠单抗治疗炎症性肠病的长期疗效：一项基于瑞典国家炎症性肠病质量登记处（SWIBREG）的全国性研究。

Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG).

作者信息

Eriksson Carl, Marsal Jan, Bergemalm Daniel, Vigren Lina, Björk Jan, Eberhardson Michael, Karling Pontus, Söderman Charlotte, Myrelid Pär, Cao Yang, Sjöberg Daniel, Thörn Mari, Karlén Per, Hertervig Erik, Strid Hans, Ludvigsson Jonas F, Almer Sven, Halfvarson Jonas

机构信息

a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.

b Immunology Section , Lund University , Lund , Sweden.

出版信息

Scand J Gastroenterol. 2017 Jun-Jul;52(6-7):722-729. doi: 10.1080/00365521.2017.1304987. Epub 2017 Mar 31.

DOI:10.1080/00365521.2017.1304987

PMID:28362144

Abstract

OBJECTIVES

Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness.

MATERIALS AND METHODS

Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn's disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC).

RESULTS

Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14-20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96-16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10-4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16-6.48).

CONCLUSION

Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

摘要

目的

临床试验已证明维多珠单抗在炎症性肠病（IBD）中的疗效。然而，这些研究结果可能无法反映临床实践情况。因此，我们旨在描述接受维多珠单抗治疗的患者群体并评估其长期疗效。

材料与方法

通过瑞典国家IBD质量登记处识别出2014年6月1日至2015年5月31日期间开始使用维多珠单抗治疗的患者。提取前瞻性收集的治疗和疾病活动数据。临床缓解定义为克罗恩病（CD）患者的哈维·布拉德肖指数＜5，溃疡性结肠炎（UC）患者的简单临床结肠炎活动指数＜3。

结果

共纳入246例患者（147例CD、92例UC和7例未分类IBD）。研究开始时，86%的患者对肿瘤坏死因子拮抗剂治疗无效，48%的CD患者接受过≥1次手术切除。中位随访17（四分位间距：14 - 20）个月后，142例（58%）患者仍在使用维多珠单抗。随访结束时，总体上54%的CD患者和64%的UC患者处于临床缓解状态，临床活动度降低（两组均p＜0.0001）。CD患者（p＜0.0001）和UC患者（p = 0.001）的粪便钙卫蛋白均降低，而CD患者的C反应蛋白降低（p = 0.002），UC患者则未降低（p = 0.11）。既往抗TNF暴露（校正风险比：4.03；95%置信区间：0.96 - 16.75）和基线时CRP升高（校正风险比：2.22；95%置信区间：1.10 - 4.35）似乎与因无反应而停药有关。女性因不耐受而停药的相关性较高（校正风险比：2.75；95%置信区间：1.16 - 6.48）。