Evidence map›Paper›PMID 12801957›Full record

Trial reportGut2003

Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial.

C S J Probert, S D Hearing, S Schreiber, T Kühbacher, S Ghosh, I D R Arnott, A Forbes

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00222378 (Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease), which is not on this map. Cited by 91 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 18 pooled it
21.1field-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.

NCT00222378 completednot on this mapstarted 2005, after this paper: background citation

Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus DNA in Intestinal Mucosa of Patients With Inflammatory Bowel Disease

TypeobservationalSponsorUniversity of MiamiRan2005 to 2012Enrolled129ConditionsCrohn's Disease, Ulcerative Colitis
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 18 syntheses or guidelines pooled it, 361 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Cyclosporine A for induction of remission in severe ulcerative colitis.The Cochrane database of systematic reviews · 2005
    Pooled it
  19. The use of infliximab for treatment of hospitalized patients with acute severe ulcerative colitis.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2008
    Trial
  20. Trial

31 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

7 authors at 4 institutions in 2 countries.

C S J ProbertUniversity Division of Medicine, Bristol Royal Infirmary, Marlborough Street, Bristol BS2 8HW, UK. c.s.j.probert@bristol.ac.uk
S D Hearing
S Schreiber
T Kühbacher
S Ghosh
I D R Arnott
A Forbes
Bristol Royal Infirmary · GBKiel University · DEWestern General Hospital · GBSt Mark's Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTumour necrosis factor production is increased in the mucosa of patients with active ulcerative colitis. The benefits of infliximab in Crohn's disease are established. We investigated its efficacy in ulcerative colitis.

methodsWe conducted a randomised placebo controlled trial of infliximab (5 mg/kg) in the treatment of glucocorticoid resistant ulcerative colitis. Infusions were given at weeks 0 and 2. Disease activity and quality of life were recorded over eight weeks of follow up. Remission was defined as an ulcerative colitis symptom score (UCSS) of < or =2 and/or Baron score of 0 at week 6. Patients not in remission were offered open label infliximab 10 mg/kg and reviewed two weeks later.

resultsAfter two weeks, there was no statistically significant difference between the infliximab and placebo groups in the proportion of patients with a Baron score of 0 (13% (3/23) v 5% (1/19) (95% confidence interval (CI) -9% to 24%); p=0.74). After six weeks, remission (UCSS < or =2) rates were 39% (9/23) versus 30% (6/20) (95% CI -19 to 34%; p=0.76). The median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group (p=0.82, Mann-Whitney U test). A Baron score of 0 was likely in either group (26% (6/23) v 30% (6/20) (95% CI -30% to 23%); p=0.96). Improvement in the IBDQ and EuroQol was not significantly different between the groups (p=0.22 and 0.3, respectively, Mann-Whitney U test). Twenty eligible patients were given open labelled infusions. Remission was achieved in 3/11 (27%) patients initially treated with infliximab and in 1/9 (11%) patients treated with placebo.

conclusionThese data do not support the use of infliximab in the management of moderately active glucocorticoid resistant ulcerative colitis.

Indexed as

AdultAntibodies, MonoclonalAnti-Inflammatory AgentsColitis, UlcerativeC-Reactive ProteinDouble-Blind MethodDrug ResistanceFemaleGlucocorticoidsHumansImmunosuppressive AgentsInfliximabMaleMiddle AgedQuality of LifeRemission InductionAntibodies, MonoclonalAnti-Inflammatory AgentsC-Reactive ProteinGlucocorticoidsImmunosuppressive AgentsInfliximab

Identifiers

PMID12801957
PMCPMC1773722
OpenAlexW2112768046

What OpenQuestion holds

Textmetadata
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.