Evidence map›Paper›PMID 22890223›Full record

ArticleThe American journal of gastroenterology2012

Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT™ registry.

Gary R Lichtenstein, Brian G Feagan, Russell D Cohen, Bruce A Salzberg, Robert H Diamond, Samiyeh Price, Wayne Langholff, Anil Londhe, William J Sandborn

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in The American journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02904590 (A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease), which is not on this map. Cited by 297 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
297citing papers in PubMed, 13 pooled it
39.1field-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.

NCT02904590 completednot on this mapstarted 2016, after this paper: background citation

A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease

Typeobservational_patient_registrySponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaRan2016Enrolled1,204ConditionsInflammatory Bowel Diseases
3 · Its place in the literature

Who cites it

297 citing papers in PubMed, 13 syntheses or guidelines pooled it, 785 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
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  5. Guideline
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  9. Effect of Concomitant Therapy With Steroids and Tumor Necrosis Factor Antagonists for Induction of Remission in Patients With Crohn's Disease: A Systematic Review and Pooled Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
    Pooled it
  10. Guideline
  11. Reversal of anti-drug antibodies against tumor necrosis factor inhibitors with addition of immunomodulators: A systematic review and meta-analysis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2020
    Pooled it
  12. Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Pooled it
  13. Safety of Biologic Therapy in Older Patients With Immune-Mediated Diseases: A Systematic Review and Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019
    Pooled it
  14. Trial
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  18. Review
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  20. Observational

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 4 countries.

Gary R LichtensteinDivision of Gastroenterology, Hospital of the University of Pennsylvania, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-4283, USA. grl@uphs.upenn.edu
Brian G Feagan
Russell D Cohen
Bruce A Salzberg
Robert H Diamond
Samiyeh Price
Wayne Langholff
Anil Londhe
William J Sandborn
Janssen (United States) · USJohnson & Johnson (United States) · USAtlanta Gastroenterology Associates · USFundación Juan March · ESUniversity of Chicago Medical Center · USUniversity of Pennsylvania · USWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe objective of this study was to contribute long-term safety data for infliximab and other therapies in Crohn's disease (CD).

methodsWe prospectively evaluated CD patients enrolled in the large, observational Crohn's Therapy, Resource, Evaluation, and Assessment Tool registry, established to compare infliximab safety with conventional nonbiological medications in CD.

resultsA total of 6,273 patients were enrolled and evaluated on or before 23 February 2010; 3,420 received infliximab (17,712 patient-years; 89.9% received ≥ 2 infusions) and 2,853 received other-treatments-only (13,251 patient-years). Mean length of patient follow-up was 5.2 years. More infliximab- than other-treatments-only-treated patients had moderate-to-severe (30.6% vs. 10.7%) or severe-to-fulminant (2.5% vs. 0.6%) disease severity (P < 0.001). In the year before enrollment, more infliximab- than other-treatments-only-treated patients required surgical intervention (17.4% vs. 13.6%), medical hospitalization (14.2% vs. 8.8%), prednisone (47.8% vs. 31.4%), immunomodulators (52.0% vs. 32.1%), and narcotic analgesics (17.3% vs. 9.1%). Patient mortality was similar for infliximab- and other-treatments-only-treated patients (0.58 vs. 0.59/100 patient-years). In multivariate logistic regression analyses, treatment with prednisone (hazard ratio (HR) = 2.14, 95% confidence interval (CI) = 1.55, 2.95; P < 0.001) or narcotic analgesics (HR = 1.79, 95% CI = 1.29, 2.48; P < 0.001) and age (HR = 1.08, 95% CI = 1.07, 1.09; P < 0.001) were associated with increased mortality risk. Neither infliximab nor immunomodulator treatment was associated with increased mortality risk. Factors independently associated with serious infections included moderate-to-severe disease activity (HR = 2.24, 95% CI = 1.57, 3.19; P < 0.001), narcotic analgesic treatment (HR = 1.98, 95% CI = 1.44, 2.73; P < 0.001), prednisone therapy (HR = 1.57, 95% CI = 1.17, 2.10; P = 0.002), and infliximab treatment (HR = 1.43, 95% CI = 1.11, 1.84; P = 0.006).

conclusionsMortality was similar between infliximab- and other-treatments-only-treated CD patients. An increased risk of serious infection with infliximab was observed, although CD severity and use of prednisone or narcotic analgesics carried higher risks.

Indexed as

AdultAntibodies, MonoclonalCrohn DiseaseFemaleFollow-Up StudiesGastrointestinal AgentsHumansImmunosuppressive AgentsInfectionsInfliximabMaleMiddle AgedPrednisoneProspective StudiesRegistriesSeverity of Illness IndexAntibodies, MonoclonalGastrointestinal AgentsImmunosuppressive AgentsInfliximabPrednisone

Identifiers

PMID22890223
PMCPMC3438468
OpenAlexW1989167852

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.