对比在抗肿瘤坏死因子治疗失败的患者中，二线生物治疗药物对于溃疡性结肠炎和克罗恩病的疗效。

Comparative effectiveness of second-line biological therapies for ulcerative colitis and Crohn's disease in patients with prior failure of anti-tumour necrosis factor treatment.

机构信息

Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

Department of Biostatistics, Graduate School of Public Health, Yonsei University, Seoul, Republic of Korea.

出版信息

BMC Gastroenterol. 2022 Mar 27;22(1):143. doi: 10.1186/s12876-022-02225-w.

DOI:10.1186/s12876-022-02225-w

PMID:35346063

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8958783/

Abstract

BACKGROUND

Therapeutic options for inflammatory bowel disease (IBD) have increased since the introduction of tumour necrosis factor (TNF) inhibitors a few decades ago. However, direct comparisons of the effectiveness of second-line biological agents in patients with ulcerative colitis (UC) and Crohn's disease (CD) are lacking.

METHODS

Patients with UC or CD who experienced anti-TNF treatment failure and subsequently used vedolizumab, ustekinumab, or tofacitinib as a second-line drug were retrospectively recruited. The primary outcomes were the clinical remission rate at week 16 and the cumulative relapse rate 48 weeks after receiving induction therapy.

RESULTS

A total of 94 patients with UC or CD experienced anti-TNF treatment failure and received vedolizumab (UC: 37; CD: 28), ustekinumab (CD: 16), or tofacitinib (UC: 13). The clinical remission rates were not significantly different between the vedolizumab and tofacitinib groups in UC patients (56.8% vs. 46.2%, p = 0.509). In CD patients, the clinical remission rates were not significantly different between the vedolizumab and ustekinumab groups (53.6% vs. 50.0%, p = 0.820). Moreover, the cumulative rates of clinical relapse were not significantly different between the vedolizumab and tofacitinib groups in UC patients and between the vedolizumab and ustekinumab groups in CD patients (p = 0.396 and p = 0.692, respectively). Safety profiles were also similar among the treatment groups in both UC and CD patients.

CONCLUSIONS

After prior anti-TNF therapy failure, vedolizumab and tofacitinib in UC patients and vedolizumab and ustekinumab in CD patients were not significantly different in terms of the efficacy in inducing and maintaining a clinical response.

摘要

背景

自几十年前肿瘤坏死因子（TNF）抑制剂问世以来，炎症性肠病（IBD）的治疗选择有所增加。然而，溃疡性结肠炎（UC）和克罗恩病（CD）患者二线生物制剂有效性的直接比较尚缺乏。

方法

回顾性招募了经历抗 TNF 治疗失败后，继而使用维得利珠单抗、乌司奴单抗或托法替布作为二线药物的 UC 或 CD 患者。主要结局是第 16 周的临床缓解率和诱导治疗后 48 周的累积复发率。

结果

共有 94 例 UC 或 CD 患者经历抗 TNF 治疗失败，接受了维得利珠单抗（UC：37 例；CD：28 例）、乌司奴单抗（CD：16 例）或托法替布（UC：13 例）。UC 患者中，维得利珠单抗组和托法替布组的临床缓解率无显著差异（56.8% vs. 46.2%，p=0.509）。在 CD 患者中，维得利珠单抗组和乌司奴单抗组的临床缓解率无显著差异（53.6% vs. 50.0%，p=0.820）。此外，UC 患者中维得利珠单抗组和托法替布组、CD 患者中维得利珠单抗组和乌司奴单抗组的临床复发累积率无显著差异（p=0.396 和 p=0.692）。UC 和 CD 患者中，各治疗组的安全性谱也相似。