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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BMC
2025-07-01
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| 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 |
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| 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. |
| format | Article |
| id | doaj-art-81318b37e9f044b280b99398c020e0c8 |
| institution | Kabale University |
| issn | 1471-230X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| 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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