Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis

YAO Duidui; LI Feixue; WU Jiaqi; LIU Xiaobing; WEN Hongping

doi:10.6039/j.issn.1001-0408.2026.10.12

您当前的位置：

首页 >

文章列表页 >

Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis

更新时间：2026-05-26

- Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis
- ZHONGGUO YAOFANG Vol. 37, Issue 10, Pages: 1307-1312(2026)
- 作者机构：
  
  1.山西省人民医院药学部，太原　030012
  2.山西医科大学药学院，山西晋中　030619
  3.山西省人民医院消化内科，太原　030012
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.10.12
  CLC： R574.62;R969.4
- Received：20 November 2025，
  
  Revised：2026-04-09，
  
  Accepted：20 April 2026，
  
  Published：30 May 2026
- 稿件说明：
移动端阅览
姚堆堆,栗菲雪,武佳琪,等.维得利珠单抗与英夫利西单抗在Bio-naive溃疡性结肠炎患者中的疗效和安全性比较 ^Δ[J].中国药房,2026,37(10):1307-1312. DOI: 10.6039/j.issn.1001-0408.2026.10.12.

YAO Duidui,LI Feixue,WU Jiaqi,et al.Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis[J].ZHONGGUO YAOFANG,2026,37(10):1307-1312.
姚堆堆,栗菲雪,武佳琪,等.维得利珠单抗与英夫利西单抗在Bio-naive溃疡性结肠炎患者中的疗效和安全性比较 ^Δ[J].中国药房,2026,37(10):1307-1312. DOI: 10.6039/j.issn.1001-0408.2026.10.12. DOI：

YAO Duidui,LI Feixue,WU Jiaqi,et al.Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis[J].ZHONGGUO YAOFANG,2026,37(10):1307-1312. DOI： 10.6039/j.issn.1001-0408.2026.10.12.

摘要

目的

比较维得利珠单抗（VDZ）与英夫利西单抗（IFX）在初次使用生物制剂（Bio-naive）中重度活动期溃疡性结肠炎（UC）患者中的疗效和安全性，并分析其疗效影响因素。

方法

回顾性收集2023年6月－2024年6月在山西省人民医院消化内科接受治疗的Bio-naive中重度活动期UC患者的临床资料。根据其所用生物制剂的种类，分为IFX组（41例）和VDZ组（30例）。两组患者均接受IFX（5 mg/kg）或VDZ（300 mg）进行诱导缓解和维持缓解治疗。比较两组患者治疗后的改良Mayo评分、血清学指标（血红蛋白、白蛋白、血小板计数、红细胞沉降率、C反应蛋白）、联合用药情况、疗效相关指标（临床反应率/缓解率、内镜反应率/缓解率）和不良反应发生情况；基于Logistic回归模型进行单因素、多因素分析，挖掘影响治疗第14周时临床缓解和治疗第38周时内镜缓解的潜在因素。

结果

两组患者治疗第14、38周时的临床反应率/缓解率、内镜反应率/缓解率比较，差异均无统计学意义（

＞0.05）；而VDZ组治疗第14周时联用激素的患者比例为26.67%，显著高于IFX组的7.50%（

＜0.05）。两组患者总不良反应发生率比较的差异虽无统计学差异（

＞0.05），但IFX组均为导致治疗中止的3级不良反应（6例），而VDZ组则为未中断治疗的2级不良反应（1例）。单因素、多因素回归分析结果显示，疾病类型（复发）与患者治疗第14周时临床缓解、有吸烟史与患者治疗第38周时内镜缓解分别显著相关（比值比均为0.08，95%置信区间分别为0.01～0.77、0.01～0.91，

＜0.05）。

结论

对于Bio-naive中重度活动期UC患者，VDZ和IFX在诱导和维持临床缓解、促进黏膜愈合方面的效果及总体安全性相当；尽管IFX可在疾病早期更快实现炎症控制，但其所致不良反应更为严重。临床类型（复发）和有吸烟史分别是影响短期临床缓解和长期内镜缓解的独立负面预测因素。

Abstract

OBJECTIVE

To compare the efficacy and safety of vedolizumab （VDZ） versus infliximab （IFX） in biologic-naive（Bio-naive） patients with moderate-to-severe active ulcerative colitis （UC）， and to analyze the factors influencing efficacy.

METHODS

Clinical data were retrospectively collected from Bio-naive patients with moderate-to-severe active UC who received treatment in the Department of Gastroenterology at Shanxi Provincial People’s Hospital from June 2023 to June 2024. Based on the type of biologic agent administered， the patients were divided into the IFX group （41 cases） and the VDZ group （30 cases）. Patients in the two groups received IFX （5 mg/kg） or VDZ （300 mg） for induction and maintenance of remission therapy. The two groups were compared regarding modified Mayo score， serological indicators （hemoglobin， albumin， platelet count， erythrocyte sedimentation rate， C-reactive protein）， combined medication， efficacy-related indexes （clinical response rate/remission rate， and endoscopic response rate/remission rate）， and the occurrence of adverse drug reactions （ADR）. Based on Logistic regression model， univariate and multivariate analyses were conducted to identify potential factors influencing clinical remission at week 14 and endoscopic remission at week 38.

RESULTS

There were no statistically significant differences in clinical response rate/remission rate， or endoscopic response rate/remission rate between the two groups at weeks 14 and 38 （

＞0.05）. However， at week 14 of treatment， the proportion of patients using concomitant corticosteroids in VDZ group was 26.67%， significantly higher than the 7.50% in IFX group （

＜0.05）. There was no statistical significance in the overall incidence of ADR between the two groups （

＞0.05）； all ADRs in the IFX group were grade 3 and led to treatment discontinuation （6 cases）， whereas ADR in the VDZ group was grade 2 and did not interrupt therapy （1 case）. Univariate and multivariate regression analyses revealed that disease type （relapsing） was significantly associated with clinical remission at week 14 of treatment， and a history of smoking was significantly associated with endoscopic remission at week 38 of treatment （the odds ratios were 0.08 for both， with 95% confidence intervals of 0.01-0.77 and 0.01-0.91 respectively，

＜0.05）.

CONCLUSIONS

For Bio-naive patients with moderate-to-severe active UC， VDZ and IFX demonstrate comparable efficacy in inducing and maintaining clinical remission and promoting mucosal healing， as well as overall safety. Although IFX can achieve faster control of inflammation in the early stage of the disease， it causes more severe ADR. Disease type （relapsing） and smoking history are identified as independent negative predictors for short-term clinical remission and long-term endoscopic remission， respectively.

关键词

Keywords

references

LE BERRE C ， HONAP S ， PEYRIN-BIROULET L . Ulcera-tive colitis [J ] . Lancet ， 2023 ， 402 （ 10401 ）： 571 - 584 .

ZHANG Y ， LIU J L ， HAN X ， et al . Long-term trends in the burden of inflammatory bowel disease in China over three decades：a joinpoint regression and age-period-cohort analysis based on GBD 2019 [J ] . Front Public Health ， 2022 ， 10 ： 994619 .

中华医学会消化病学分会炎症性肠病学组，中国炎症性肠病诊疗质量控制评估中心 . 中国溃疡性结肠炎诊治指南：2023年·西安 [J ] . 胃肠病学， 2024 ， 29 （ 3 ）： 145 - 173 .

FERREIRA A I ， LIMA CAPELA T ， ARIEIRA C ， et al . Subcutaneous versus intravenous infliximab therapy：a real-world study：toward higher drug concentrations [J ] . Eur J Gastroenterol Hepatol ， 2024 ， 36 （ 11 ）： 1314 - 1318 .

SAEED M H ， ISMAIL A ， THIRUSELVAN K ， et al . P0981 comparative efficacy of standard vs enhanced dose treatment with infliximab in the management of acute severe ulcerative colitis：a single centre retrospective cohort study [J ] . J Crohn’s Colitis ， 2025 ， 19 （ Suppl. 1 ）： i1823 .

BAR-YOSEPH H ， LEVHAR N ， SELINGER L ， et al . Early drug and anti-infliximab antibody levels for prediction of primary nonresponse to infliximab therapy [J ] . Aliment Pharmacol Ther ， 2018 ， 47 （ 2 ）： 212 - 218 .

KOLHO K L ， RUUSKA T ， SAVILAHTI E . Severe adverse reactions to infliximab therapy are common in young children with inflammatory bowel disease [J ] . Acta Paediatr ， 2007 ， 96 （ 1 ）： 128 - 130 .

LAMB C A ， O’BYRNE S ， KEIR M E ， et al . Gut-selective integrin-targeted therapies for inflammatory bowel disease [J ] . J Crohns Colitis ， 2018 ， 12 （ Suppl. 2 ）： S653 - S668 .

DOMÈNECH E ， GISBERT J P . Efficacy and safety of vedolizumab in the treatment of ulcerative colitis [J ] . Gastroenterol Hepatol ， 2016 ， 39 （ 10 ）： 677 - 686 .

LI M ， XIE Y ， TIAN F . P0689 A clinical study on the optimization of vedolizumab induction therapy for moderate to severe active ulcerative colitis at week 10 [J ] . J Crohns Colitis ， 2025 ， 19 （ Suppl. 1 ）： i1346 .

CHHIBBA T ， WONG E C L ， REINISCH W ， et al . Comparing the efficacy of vedolizumab between males and females：a post-hoc analysis of GEMINI-1 and VARSITY [J ] . Eur J Gastroenterol Hepatol ， 2024 ， 36 （ 6 ）： 704 - 711 .

MANTZARIS G J ， BRESSLER B ， ADSUL S ， et al . Effectiveness and safety of vedolizumab and infliximab in biologic-naive patients with Crohn’s disease：results from the EVOLVE study [J ] . Eur J Gastroenterol Hepatol ， 2024 ， 36 （ 3 ）： 281 - 291 .

SABLICH R ， URBANO M T ， SCARPA M ， et al . Vedolizumab is superior to infliximab in biologic naïve patients with ulcerative colitis [J ] . Sci Rep ， 2023 ， 13 ： 1816 .

ZHANG M ， LI M M ， OU Y Z ， et al . Infliximab for patients with moderate to severely active ulcerative colitis：an updated meta-analysis of randomized controlled trials [J ] . BMC Gastroenterol ， 2025 ， 25 （ 1 ）： 458 .

NARULA N ， WONG E C L ， MARSHALL J K ， et al . Comparative efficacy for infliximab vs vedolizumab in biologic naive ulcerative colitis [J ] . Clin Gastroenterol Hepatol ， 2022 ， 20 （ 7 ）： 1588 - 1597.e3 .

PEYRIN-BIROULET L ， ARKKILA P ， ARMUZZI A ，　 et al . Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease：a systematic review and meta-analysis [J ] . BMC Gastroenterol ， 2022 ， 22 （ 1 ）： 291 .

孟锐萍，黄宝宝，刘恩，等 . 维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究 [J ] . 陆军军医大学学报， 2024 ， 46 （ 12 ）： 1417 - 1424 .

YOUDIM A ， VASILIAUSKAS E A ， TARGAN S R ， et al . A pilot study of adalimumab in infliximab-allergic patients [J ] . Inflamm Bowel Dis ， 2004 ， 10 （ 4 ）： 333 - 338 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Study on the efficacy and safety of 3 kinds of novel biologics in the treatment of Crohn’s disease

双歧杆菌三联活菌胶囊治疗溃疡性结肠炎的临床观察

美沙拉嗪联合双歧杆菌四联活菌治疗活动期溃疡性结肠炎的临

Efficacy of toludesvenlafaxine in the treatment of patients with major depressive disorder with anhedonia

Mechanism of Huangqin decoction in improving ulcerative colitis based on the gut microbiota-tryptophan metabolism-aryl hydrocarbon receptor axis

Related Author

WU Fei

CHEN Yongwu

WU Weijia

WU Furong

WU Yingqi

SHEN Aizong

MAO Li-xin

GUO Yuan-chun

Related Institution

Anhui Provincial Technology Center for Clinical Comprehensive Evaluation of Drugs

Dept. of Pharmacy， the First Affiliated Hospital of USTC （Anhui Provincial Hospital）

Dept. of Psychiatry，Hebei Mental Health Center （the Sixth People’s Hospital of Hebei Province）/Hebei Key Laboratory for Major Mental and Behavioral Disorders/the Sixth Clinical Medical College of Hebei University

Dept. of the Second Geriatric Psychiatry，Hebei Mental Health Center （the Sixth People’s Hospital of Hebei Province）/Hebei Key Laboratory for Major Mental and Behavioral Disorders/ the Sixth Clinical Medical College of Hebei University

Dept. of the Second Clinical Psychology，Hebei Mental Health Center （the Sixth People’s Hospital of Hebei Province）/Hebei Key Laboratory for Major Mental and Behavioral Disorders/ the Sixth Clinical Medical College of Hebei University

⁰