Evidence map›Paper›PMID 34333908›Full record

ArticleIntestinal research2022

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation.

Brigida Barberio, Edoardo Vincenzo Savarino, Timothy Card, Cristina Canova, Francesco Baldisser, Alessandro Gubbiotti, Davide Massimi, Matteo Ghisa, Fabiana Zingone

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Intestinal research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% of its field
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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Observational
  8. Review
  9. Article
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

9 authors at 2 institutions in 2 countries.

Brigida BarberioDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Edoardo Vincenzo SavarinoDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Timothy CardNIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.
Cristina CanovaDepartment of Cardio-Thoraco-Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Francesco BaldisserDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Alessandro GubbiottiDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Davide MassimiDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Matteo GhisaDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
Fabiana ZingoneDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology (DISCOG), University of Padua, Padua, Italy.
University of Padua · ITNottingham University Hospitals NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsCurrent literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.

methodsIn this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.

resultsA total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).

conclusionsVDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

Indexed as

AdalimumabAdverse eventsBiological therapyInflammatory bowel diseaseVedolizumab

Identifiers

PMID34333908
PMCPMC8831779
OpenAlexW3187277493

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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.