Evidence map›Paper›PMID 40979029›Full record

ReviewCureus2025

Evaluating the Effectiveness and Safety of Vedolizumab in Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abdulraouf Flemban, Hamzah A Bakhor, Raghad Almuzaini, Taif Alshahrani, Raghid A Alahmadi, Raneem Alshurbi, Khaldah Althobiti, Hams Alwadai, Sufyan Maghrabi, Najwa Alkhairy and 2 more

Abstract readReview
In one paragraph

Review in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Abdulraouf FlembanPharmacy, Umm Al-Qura University, Makkah, SAU.
Hamzah A BakhorMedicine, Ibn Sina National College, Jeddah, SAU.
Raghad AlmuzainiPharmacy, Taibah University, Madinah, SAU.
Taif AlshahraniMedicine, King Khalid University, Abha, SAU.
Raghid A AlahmadiPharmacy, Umm Al-Qura University, Makkah, SAU.
Raneem AlshurbiMedicine, Taif University, Taif, SAU.
Khaldah AlthobitiMedicine, King Faisal Medical Complex, Taif, SAU.
Hams AlwadaiMedicine, Imam Mohammad Ibn Saud Islamic University, Riyadh, SAU.
Sufyan MaghrabiMedicine, King Abdulaziz University, Jeddah, SAU.
Najwa AlkhairyMedicine, Umm Al-Qura University, Makkah, SAU.
Moath ShawoshMedicine and Surgery, Faculty of Medicine, University of Jeddah, Jeddah, SAU.
Taghreed ZamzamiClinical Pharmacy, King Abdullah Medical City, Makkah, SAU.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ulcerative colitis (UC) significantly affects patients' lives, and treatment options may be constrained due to severe side effects. Vedolizumab, a monoclonal antibody that specifically targets the α4β7 integrin, has recently demonstrated potential as a gut-specific therapy with fewer adverse effects compared to other biological treatments. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of vedolizumab in adults with moderate to severe UC. The research team reviewed three prominent databases - PubMed, Google Scholar, and Cochrane Central Register of Controlled Trials (CENTRAL) - adhering to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) criteria, to identify randomized controlled trials that compared vedolizumab with placebo or other treatments for moderate to severe UC. A total of 1,571 preliminary studies were screened, resulting in the inclusion of six trials with 1,618 people. The primary outcomes included clinical remission, mucosal healing, clinical response, corticosteroid-free remission, and adverse events such as infections and infusion site responses. Data indicate that vedolizumab markedly enhanced endoscopic remission relative to placebo, nearly doubling the likelihood of remission for patients (risk ratio (RR) = 2.25; p = 0.01). Despite the prevalence of clinical remission in the vedolizumab cohort, this outcome lacks statistical significance (RR = 2.10; p = 0.07). No substantial advantage was observed in corticosteroid-free remission (RR = 1.69; p = 0.58). Vedolizumab exhibited an acceptable safety profile, with adverse event rates comparable to those of a placebo. Nonetheless, minor infections and infusion responses occurred with slightly greater frequency. Vedolizumab enhances endoscopic healing and clinical response in individuals with moderate to severe UC while maintaining an acceptable safety profile. This therapeutic option is particularly significant for individuals who experience difficulties with alternative therapies. Future head-to-head trials comparing vedolizumab with other biological therapies may elucidate its role in treatment regimens.

Indexed as

clinical remissionmucosal healingsafetyulcerative colitisvedolizumab

Identifiers

PMID40979029
PMCPMC12444721

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.