Evidence map›Paper›PMID 29925913›Full record

SynthesisThe American journal of gastroenterology2018

No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials.

Siddharth Singh, James A Proudfoot, Parambir S Dulai, Vipul Jairath, Mathurin Fumery, Ronghui Xu, Brian G Feagan, William J Sandborn

Erratum issued Registry-linked trialOpen access · greenAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The American journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00336492 (A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT00336492 phase3completednot on this map

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE�) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorCentocor, Inc.Ran2006 to 2010Enrolled60ConditionsUlcerative ColitisArmsinfliximab
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025
    Review
  5. A practical approach to positioning therapies in ulcerative colitis.Journal of the Canadian Association of Gastroenterology · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
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  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
James A ProudfootDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
Vipul JairathDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
Mathurin FumeryDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
Ronghui XuDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
Brian G FeaganDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA. Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA. Division of Epidemiology and Biostatistics, Western University, London, ON, Canada. Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada. Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France. Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.
University of California, San Diego · USUniversité de Picardie Jules Verne · FRUniversity Hospital · CAWestern University · CA

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
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
NCATS NIH HHS UL1 TR001442NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

objectives5-aminosalicylates (5-ASA) are frequently continued in patients with moderate-severe ulcerative colitis (UC), even after escalation to biologic agents, without evaluation of the benefit of this approach. We conducted an individual participant data (IPD) pooled analysis of trials of infliximab and golimumab in UC, to evaluate whether concomitant use of 5-ASA modifies clinical outcomes among anti-tumor necrosis factor (TNF)-α-treated patients.

methodsWe included IPD from five trials of infliximab and golimumab in patients with moderate-severe UC (ACT-1 and -2, PURSUIT-SC, PURSUIT-M, NCT00336492). Patients treated with infliximab or golimumab were categorized as receiving concomitant 5-ASA or not at time of trial entry. Primary outcome was clinical remission (Mayo Clinic Score < 3) at last follow-up for each trial; secondary outcomes were clinical response and mucosal healing. Using multivariable logistic regression analysis, we evaluated association between concomitant 5-ASA and clinical remission, after adjusting for sex, smoking, baseline disease activity, disease extent, biochemical variables (C-reactive protein, albumin, hemoglobin), and concomitant prednisone and immunomodulators.

resultsWe included 2183 infliximab-treated or golimumab-treated patients (1715 [78.6%] on 5-ASA). Concomitant use of 5-ASA was not associated with odds of achieving clinical remission (adjusted OR, 0.67 [95% CI, 0.45-1.01], p = 0.06), clinical response (aOR, 0.89 [0.60-1.33], p = 0.58) or mucosal healing (aOR, 1.12 [0.82-1.51], p = 0.48). These results were consistent in trials of induction and maintenance therapy, and in trials of infliximab and golimumab.

conclusionsBased on IPD pooled analysis, in patients with moderate-severe UC who are escalated to anti-TNF therapy, continuing 5-ASA does not improve clinical outcomes.

Indexed as

Aminosalicylic AcidAntibodies, MonoclonalBiological TherapyColitis, UlcerativeDrug Therapy, CombinationHumansInfliximabRandomized Controlled Trials as TopicTreatment OutcomeTumor Necrosis Factor-alphaAminosalicylic AcidAntibodies, MonoclonalgolimumabInfliximabTumor Necrosis Factor-alpha

Identifiers

PMID29925913
PMCPMC7107271
OpenAlexW2808733186

What OpenQuestion holds

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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.