Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials

Abstract Background and aims Ulcerative colitis (UC) is a serious inflammatory bowel disease with significant morbidity and mortality. Infliximab (IFX), a TNF-alpha antagonist, is recommended by the American Gastroenterological Association, but its clinical effectiveness and safety are based on limi...

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Main Authors: Min Zhang, Manman Li, Yangzan Ou, Qin Huang, Mingmin Leng, Xiangdong Yang, Tao Yang
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Gastroenterology
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Online Access:https://doi.org/10.1186/s12876-025-04065-w
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author Min Zhang
Manman Li
Yangzan Ou
Qin Huang
Mingmin Leng
Xiangdong Yang
Tao Yang
author_facet Min Zhang
Manman Li
Yangzan Ou
Qin Huang
Mingmin Leng
Xiangdong Yang
Tao Yang
author_sort Min Zhang
collection DOAJ
description Abstract Background and aims Ulcerative colitis (UC) is a serious inflammatory bowel disease with significant morbidity and mortality. Infliximab (IFX), a TNF-alpha antagonist, is recommended by the American Gastroenterological Association, but its clinical effectiveness and safety are based on limited studies. This meta-analysis of randomized controlled trials (RCTs) evaluates the efficacy and safety of IFX in moderate-to-severe active UC, providing evidence for its clinical application. Methods A systematic search of major English (PubMed, MEDLINE, Web of Science, Embase, Cochrane Library) and Chinese databases (CNKI, SinoMed, Wanfang, VIP) was conducted up to September 25, 2023, to identify RCTs comparing IFX against placebo, aminosalicylates, corticosteroids, or immunosuppressants for moderate-to-severe UC. Pooled analyses assessed short- and long-term clinical response, clinical remission, endoscopic remission (mucosal healing), safety outcomes, and corresponding 95% confidence intervals. Subgroup analyses, heterogeneity assessment, sensitivity analyses, publication bias evaluation (funnel plots), and meta-regression were performed. Results Twenty RCTs involving 2,350 patients (IFX: n = 1,300; controls: n = 1,050) were included. IFX demonstrated significant superior efficacy versus controls across all primary endpoints: short-term (RR = 1.38, P < 0.001) and long-term clinical response (RR = 1.52, P = 0.007); short-term (RR = 1.38, P < 0.001) and long-term clinical remission (RR = 1.52, P = 0.022); short-term (RR = 1.58, P = 0.001) and long-term endoscopic remission (RR = 1.39, P = 0.010). Adverse event rates did not differ significant between groups (RR = 1.00, P = 0.933). Meta-regression suggested geographical region as a potential source of heterogeneity for short-term clinical response. Conclusions IFX has a more positive effect on active UC than placebos, aminosalicylic acid preparations, steroids, or immunosuppressive drugs, but shows no superiority in terms of adverse responses.
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spelling doaj-art-81318b37e9f044b280b99398c020e0c82025-08-20T03:38:18ZengBMCBMC Gastroenterology1471-230X2025-07-0125111410.1186/s12876-025-04065-wInfliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trialsMin Zhang0Manman Li1Yangzan Ou2Qin Huang3Mingmin Leng4Xiangdong Yang5Tao Yang6Colorectal and Anal Surgery, Deyang People’s HospitalSchool of Clinical Medicine, Guizhou University of Traditional Chinese MedicineColorectal and Anal Surgery, Deyang People’s HospitalColorectal and Anal Surgery, Deyang People’s HospitalColorectal and Anal Surgery, Deyang People’s HospitalColorectal and Anal Surgery, Chengdu Anorectal HospitalThe First Affiliated Hospital of Guizhou, University of Traditional Chinese MedicineAbstract Background and aims Ulcerative colitis (UC) is a serious inflammatory bowel disease with significant morbidity and mortality. Infliximab (IFX), a TNF-alpha antagonist, is recommended by the American Gastroenterological Association, but its clinical effectiveness and safety are based on limited studies. This meta-analysis of randomized controlled trials (RCTs) evaluates the efficacy and safety of IFX in moderate-to-severe active UC, providing evidence for its clinical application. Methods A systematic search of major English (PubMed, MEDLINE, Web of Science, Embase, Cochrane Library) and Chinese databases (CNKI, SinoMed, Wanfang, VIP) was conducted up to September 25, 2023, to identify RCTs comparing IFX against placebo, aminosalicylates, corticosteroids, or immunosuppressants for moderate-to-severe UC. Pooled analyses assessed short- and long-term clinical response, clinical remission, endoscopic remission (mucosal healing), safety outcomes, and corresponding 95% confidence intervals. Subgroup analyses, heterogeneity assessment, sensitivity analyses, publication bias evaluation (funnel plots), and meta-regression were performed. Results Twenty RCTs involving 2,350 patients (IFX: n = 1,300; controls: n = 1,050) were included. IFX demonstrated significant superior efficacy versus controls across all primary endpoints: short-term (RR = 1.38, P < 0.001) and long-term clinical response (RR = 1.52, P = 0.007); short-term (RR = 1.38, P < 0.001) and long-term clinical remission (RR = 1.52, P = 0.022); short-term (RR = 1.58, P = 0.001) and long-term endoscopic remission (RR = 1.39, P = 0.010). Adverse event rates did not differ significant between groups (RR = 1.00, P = 0.933). Meta-regression suggested geographical region as a potential source of heterogeneity for short-term clinical response. Conclusions IFX has a more positive effect on active UC than placebos, aminosalicylic acid preparations, steroids, or immunosuppressive drugs, but shows no superiority in terms of adverse responses.https://doi.org/10.1186/s12876-025-04065-wUlcerative colitisInfliximabTNF-alpha antagonistsEvidence-based practiceMeta-analysis
spellingShingle Min Zhang
Manman Li
Yangzan Ou
Qin Huang
Mingmin Leng
Xiangdong Yang
Tao Yang
Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
BMC Gastroenterology
Ulcerative colitis
Infliximab
TNF-alpha antagonists
Evidence-based practice
Meta-analysis
title Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
title_full Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
title_fullStr Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
title_full_unstemmed Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
title_short Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials
title_sort infliximab for patients with moderate to severely active ulcerative colitis an updated meta analysis of randomized controlled trials
topic Ulcerative colitis
Infliximab
TNF-alpha antagonists
Evidence-based practice
Meta-analysis
url https://doi.org/10.1186/s12876-025-04065-w
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