Evidence map›Paper›PMID 30420398›Full record

ArticleGut2019

Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts.

Ryan C Ungaro, Berkeley N Limketkai, Camilla Bjørn Jensen, Kristine Højgaard Allin, Manasi Agrawal, Thomas Ullman, Jean-Frederic Colombel, Tine Jess

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter Study
In one paragraph

Article in Gut, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06878495 (Optimizing IBD Management), which is not on this map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT06878495 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Optimizing IBD Management: A Comparative Study on the Efficacy and Safety of 5-ASA De-escalation in Patients With Ulcerative Colitis and Crohn's Disease on Stable Biologic or Immunomodulator Therapy

TypeinterventionalSponsorPusan National University HospitalRan2025 to 2025Enrolled100ConditionsUlcerative Colitis (UC), Crohn&#39, s Disease, Inflammatory Bowel Disease (IBD)ArmsDiscontinuation of 5-ASA
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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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

8 authors at 5 institutions in 2 countries.

Ryan C Ungaro *Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
Berkeley N Limketkai *Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA.
Camilla Bjørn JensenCenter for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Kristine Højgaard AllinCenter for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Manasi AgrawalDivision of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Thomas UllmanDivision of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Jean-Frederic Colombel *Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
Tine Jess *Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Albert Einstein College of Medicine · USFrederiksberg Hospital · DKIcahn School of Medicine at Mount Sinai · USCenter for Clinical Research and Prevention · DKStanford University · US

Funding

Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns DiseaseK23DK111995 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI UNGARO, RYAN · 2019 to 2023
$948k
NCATS NIH HHS UL1 TR001085NIDDK NIH HHS K23 DK111995
6 · The paper itself

Abstract

objectiveThe benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.

designOur primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA.

resultsA total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.

conclusionIn two national databases, stopping 5-ASA in patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalBiological TherapyCohort StudiesColitis, UlcerativeDatabases, FactualDenmarkDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateMaleMesalamineProportional Hazards ModelsRetrospective StudiesAnti-Inflammatory Agents, Non-SteroidalMesalamine5-aminosalicylatesbiologicmesalamineulcerative colitis

Identifiers

PMID30420398
PMCPMC7057119
OpenAlexW2901862653

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.