维多珠单抗治疗的真实世界患者中高治疗持续率和显著内镜愈合——一项芬兰全国炎症性肠病队列研究（FINVEDO）

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO).

作者信息

Ylisaukko-Oja Tero, Aaltonen Jaakko, Nuutinen Heikki, Blomster Timo, Jussila Airi, Pajala Markku, Salminen Kimmo, Moilanen Veikko, Hakala Kalle, Kellokumpu Mikko, Toljamo Kari, Rautiainen Henna, Kuisma Juha, Peräaho Markku, Molander Pauliina, Silvennoinen Jouni, Liukkonen Ville, Henricson Hans, Tillonen Jyrki, Esterinen Mirva, Nielsen Christian, Hirsi Eija, Lääne Margus, Suhonen Ulla-Maija, Vihriälä Ilkka, Mäkelä Petri, Puhto Mika, Punkkinen Jari, Sulonen Hannu, Herrala Sauli, Jokelainen Jari, Tamminen Klaus, Sipponen Taina

机构信息

a Takeda Oy , Helsinki , Finland.

b MedEngine Oy , Helsinki , Finland.

出版信息

Scand J Gastroenterol. 2018 Feb;53(2):158-167. doi: 10.1080/00365521.2017.1416160. Epub 2017 Dec 19.

DOI:10.1080/00365521.2017.1416160

PMID:29258369

Abstract

OBJECTIVES

The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients.

METHODS

This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation.

RESULTS

A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6.

CONCLUSIONS

Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

摘要

目的

维多珠单抗治疗炎症性肠病（IBD）的有效性和耐受性已在广泛的GEMINI临床试验项目中得到证实。临床试验所代表的患者群体经过高度筛选，因此，在现实临床实践中证明其有效性很重要。我们着手评估维多珠单抗在芬兰全国范围内一组治疗难治性克罗恩病（CD）和溃疡性结肠炎（UC）患者中的实际治疗效果。

方法

这是一项全国性、回顾性、非干预性、多中心病历回顾研究。自维多珠单抗在芬兰上市以来，来自27个芬兰胃肠病学中心的所有诊断为UC或CD且至少接受过一次维多珠单抗输注的成年患者被纳入研究。数据在基线、第14周和第6个月时从病历中进行回顾性收集。主要结局指标是维多珠单抗开始治疗后24周的治疗持续性。

结果

共纳入247例患者（108例CD，139例UC）。所有CD患者中有75.0%（n = 81）、所有UC患者中有66.2%（n = 92）在开始治疗后6个月持续接受维多珠单抗治疗。在第6个月时，持续接受治疗的CD患者中有41.8%（28/67）、持续接受治疗的UC患者中有73.3%（63/86）实现了临床缓解。在第6个月时，持续接受治疗的患者在内镜评分方面有显著改善（CD，n = 17，SES-CD变化值=-5.5，p = 0.008；UC，n = 26，梅奥内镜评分变化值=-0.5，p = 0.003）。