Evidence map›Paper›PMID 30876964›Full record

SynthesisClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2020

Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.

Siddharth Singh, Antonio Facciorusso, Parambir S Dulai, Vipul Jairath, William J Sandborn

Open access · bronzeAbstract readComparative StudyMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 109 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 9 pooled it
20.6field-weighted citation impact, top 1% 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

109 citing papers in PubMed, 9 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
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  10. Trial
  11. Article
  12. The Burden of Viral Respiratory Infections in Immunosuppressed Inflammatory Bowel Disease Patients.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Article
  13. Article
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  15. Review
  16. Knowledge and uptake of vaccination in patients with ulcerative colitis from a region with no adult vaccination program.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Article
  17. Review
  18. Article
  19. Article
  20. Article

49 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 3 countries.

Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu.
Antonio FacciorussoGastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California.
Vipul JairathDivision of Gastroenterology, Department of Medicine, University Hospital, Ontario, Canada; Division of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California.
University of California San Diego · USUniversity of Foggia · ITWestern University · CA

Funding

Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

BACKGROUND &

aimsWe performed a systematic review and meta-analysis to evaluate the comparative risk of serious infections with tumor necrosis factor (TNF) antagonists, non-TNF targeted biologics, tofacitinib, and immunosuppressive agents in patients with inflammatory bowel diseases (IBDs).

methodsIn a systematic search of publications, through March 18, 2018, we identified 15 observational studies (>500 person-years) of patients with IBD treated with TNF antagonists, non-TNF targeted biologics, tofacitinib, and/or immunosuppressive agents (thiopurines, methotrexate) that reported risk of serious infections. Only studies with active comparators were included, to allow appropriate comparative synthesis. We performed random-effects meta-analysis and estimated relative risk (RR) and 95% CIs.

resultsCompared with anti-TNF monotherapy, risk of serious infection increased with the combination of anti-TNF and an immunosuppressive agent (in 6 cohorts: RR, 1.19; 95% CI, 1.03-1.37), with anti-TNF and a corticosteroid (in 4 cohorts: RR, 1.64; 95% CI, 1.33-2.03), or with all 3 drugs (in 2 cohorts: RR, 1.35; 95% CI, 1.04-1.77); there was minimal heterogeneity among studies. In contrast, monotherapy with an immunosuppressive agent was associated with a lower risk of serious infections than monotherapy with a TNF antagonist (7 cohorts: RR, 0.61; 95% CI 0.44-0.84) or a TNF antagonist with an immunosuppressive agent (2 cohorts: RR, 0.56; 95% CI, 0.39-0.81). Infliximab-based therapy was associated with a lower risk of serious infections compared with adalimumab-based therapy in patients with ulcerative colitis (4 cohorts: RR, 0.57; 95% CI, 0.33-0.97), but not Crohn's disease (4 cohorts: RR, 0.91; 95% CI, 0.49-1.70). Few data were available on the comparative safety of biologic agents that do not inhibit TNF and tofacitinib.

conclusionsCombination therapies for IBD that include TNF antagonists, especially with corticosteroids, are associated with a higher risk of serious infection, whereas monotherapy with an immunosuppressive agent is associated with a lower risk, compared with monotherapy with a TNF antagonist. Studies are needed to evaluate the comparative safety of non-TNF targeted biologics and small molecules for treatment of IBD.

Indexed as

Biological ProductsHumansImmunosuppressive AgentsInfectionsInflammatory Bowel DiseasesPiperidinesProtein Kinase InhibitorsPyrimidinesTumor Necrosis Factor-alphaBiological ProductsImmunosuppressive AgentsPiperidinesProtein Kinase InhibitorsPyrimidinestofacitinibTumor Necrosis Factor-alphaCDCrohn’s DiseaseUCUstekinumabVedolizumab

Identifiers

PMID30876964
PMCPMC8011651
OpenAlexW2920997743

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.