ArticleJournal of Crohn's & colitis2018
Respiratory Tract Infections in Patients With Inflammatory Bowel Disease: Safety Analyses From Vedolizumab Clinical Trials.
Article in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events.International journal of colorectal disease · 2020Pooled it
- The Burden of Viral Respiratory Infections in Immunosuppressed Inflammatory Bowel Disease Patients.JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- Real-World Safety of Vedolizumab in Inflammatory Bowel Disease: A Retrospective Cohort Study Supported by FAERS Signal Analysis.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Lung Involvement in Inflammatory Bowel Diseases: Shared Pathways and Unwanted Connections.Journal of clinical medicine · 2023Review
- Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2022Article
- Review
- Evidence-based clinical practice guidelines for inflammatory bowel disease 2020.Journal of gastroenterology · 2021Review
- Is Vedolizumab Truly Gut Selective? It May Not Affect the Immunogenicity of Vaccines in Patients With Inflammatory Bowel Disease.Crohn's & colitis 360 · 2020Article
- Review article: prevention, diagnosis and management of COVID-19 in the IBD patient.Alimentary pharmacology & therapeutics · 2020Review
- [Addendum to S3-Guidelines Crohn's disease and ulcerative colitis: Management of Patients with Inflammatory Bowel Disease in the COVID-19 Pandemic - open questions and answers].Zeitschrift fur Gastroenterologie · 2020Article
- Respiratory Tract Infections in Inflammatory Bowel Disease Patients Taking Vedolizumab: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in pharmacology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsVedolizumab, a humanised monoclonal antibody for the treatment of inflammatory bowel disease, selectively blocks gut lymphocyte trafficking. This may reduce the risk of respiratory tract infections [RTIs] compared with systemic immunosuppressive therapies. To assess this possibility, we evaluated the rates of RTIs in clinical trials of vedolizumab.
methodsPatient-level data from Phase 3 randomised controlled trials [RCTs] of vedolizumab in ulcerative colitis [UC; GEMINI 1] and Crohn's disease [CD; GEMINI 2], and a long-term safety study [UC and CD] were pooled. Cox proportional hazards models were used to estimate the incidence of upper RTIs [URTIs] and lower RTIs [LRTIs] with adjustment for significant covariates.
resultsIn the RCTs [n = 1731 patients], the incidence of URTIs was numerically higher in patients receiving vedolizumab compared with those receiving placebo, although this difference was not statistically significant (38.7 vs 33.0 patients per 100 patient-years; hazard ratio [HR] 1.12; 95% confidence interval [CI]: 0.83-1.51; p = 0.463). The rate of LRTIs, including pneumonia, was numerically lower in the vedolizumab versus the placebo group: this difference was not statistically significant (7.7 vs 8.5 per 100 patient-years [HR 0.85; 95% CI: 0.48-1.52; p = 0.585]). Both URTIs and LRTIs were more frequent in patients with CD compared with UC. Most RTIs in patients receiving vedolizumab were not serious and did not require treatment discontinuation.
conclusionsVedolizumab therapy was not associated with an increased incidence of respiratory tract infection compared with placebo.
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What OpenQuestion holds
Registered trials
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.