德国胃肠病学实践中随访的炎症性肠病患者二线维得利珠单抗与肿瘤坏死因子-α抑制剂的 3 年持续缓解率的对比分析。

Comparative Analysis of the 3-Year Persistence Rate with Second-Line Vedolizumab and Tumor Necrosis Factor-α Inhibitors in Patients with Inflammatory Bowel Disease Followed in Gastroenterology Practices in Germany.

机构信息

Practice for Internal Medicine, Oldenburg, Germany.

First Department of Medical, University Hospital Kiel, Kiel, Germany.

出版信息

Dig Dis. 2020;38(6):466-473. doi: 10.1159/000506121. Epub 2020 Feb 11.

DOI:10.1159/000506121

PMID:32045927

Abstract

BACKGROUND

Our goal was to investigate the 3-year persistence rates with second-line vedolizumab and tumor necrosis factor-α (TNF-α) inhibitors (i.e., adalimumab, golimumab, infliximab) in patients with inflammatory bowel disease (IBD) who were followed in gastroenterology practices in Germany.

METHODS

This study included patients aged ≥18 years who had received prescriptions for second-line biological drugs in Germany between 2014 and 2017 (n = 5,150) retrieved from the longitudinal prescription database. Vedolizumab users were matched to adalimumab, golimumab, and infliximab users based on age, sex, and index year. The primary outcome of the study was the rate of persistence with vedolizumab compared with the rate of persistence with adalimumab, golimumab, and infliximab within 3 years of second-line therapy initiation in IBD patients. Persistence was estimated as therapy time without discontinuation, with discontinuation being defined as at least 90 days without any prescription for the biological drug of interest.

RESULTS

After matching patients who had received vedolizumab with those who had received adalimumab, the rate of persistence after 3 therapy years was 30.3% for vedolizumab and 27.9% for adalimumab (log-rank p = 0.005). The corresponding figures were 27.8 and 20.8% in the vedolizumab-golimumab matched-pair analysis (log-rank p < 0.001) and 29.5 and 25.2% in the vedolizumab-infliximab matched-pair analysis (log-rank p value = 0.008). Vedolizumab was associated with a significant 0.85-, 0.72-, and 0.86-fold decrease in the risk of discontinuation within 3 years of therapy initiation compared to adalimumab, golimumab, and infliximab, respectively.

CONCLUSIONS

Treatment persistence was higher for vedolizumab than for TNF-α inhibitors up to 3 years after initiating second-line biological therapy.

摘要

背景

我们的目标是调查在德国胃肠病诊所接受二线维得利珠单抗和肿瘤坏死因子-α（TNF-α）抑制剂（即阿达木单抗、古利昔单抗、英夫利昔单抗）治疗的炎症性肠病（IBD）患者的 3 年持续率。

方法

本研究纳入了 2014 年至 2017 年期间在德国接受二线生物药物治疗的年龄≥18 岁的患者（n=5150），这些患者的信息来自纵向处方数据库。根据年龄、性别和索引年，将维得利珠单抗使用者与阿达木单抗、古利昔单抗和英夫利昔单抗使用者进行匹配。研究的主要结局是在二线治疗开始后 3 年内，维得利珠单抗的持续率与阿达木单抗、古利昔单抗和英夫利昔单抗的持续率相比。持续性是通过无停药治疗时间来估计的，停药定义为至少 90 天未开任何感兴趣的生物药物处方。

结果

在匹配接受维得利珠单抗治疗的患者和接受阿达木单抗治疗的患者后，在第 3 个治疗年，维得利珠单抗的持续率为 30.3%，阿达木单抗的持续率为 27.9%（对数秩检验 p=0.005）。在维得利珠单抗-古利昔单抗匹配对分析中，相应的比例为 27.8%和 20.8%（对数秩检验 p<0.001），在维得利珠单抗-英夫利昔单抗匹配对分析中，相应的比例为 29.5%和 25.2%（对数秩检验 p 值=0.008）。与阿达木单抗、古利昔单抗和英夫利昔单抗相比，维得利珠单抗在治疗开始后 3 年内停药的风险分别显著降低了 0.85 倍、0.72 倍和 0.86 倍。