Evidence map›Paper›PMID 31419574›Full record

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

Stopping Mesalamine Therapy in Patients With Crohn's Disease Starting Biologic Therapy Does Not Increase Risk of Adverse Outcomes.

Ryan C Ungaro, Berkeley N Limketkai, Camilla Bjørn Jensen, Clara Yzet, Kristine H Allin, Manasi Agrawal, Thomas Ullman, Johan Burisch, Tine Jess, Jean-Frederic Colombel

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article 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. It is linked to trial NCT06878495 (Optimizing IBD Management), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

15 citing papers in PubMed, 31 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Burden of Crohn's Disease in the United States Medicaid Population, 2010-2019.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    Article
  5. Review
  6. Article
  7. Article
  8. Review
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  10. Article
  11. Review
  12. Article
  13. Observational
  14. Article
  15. Risk of neutropenia in inflammatory bowel disease patients treated with TNF inhibitors: A single-center, retrospective cohort study.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2020
    Article
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

10 authors at 4 institutions in 2 countries.

Ryan C UngaroDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: ryan.ungaro@mssm.edu.
Berkeley N LimketkaiDivision of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California.
Camilla Bjørn JensenCenter for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Clara YzetDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Kristine H 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.
Thomas UllmanDivision of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Johan BurischCenter for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Tine JessCenter for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
Jean-Frederic ColombelDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Frederiksberg Hospital · DKIcahn School of Medicine at Mount Sinai · USAlbert Einstein College of Medicine · USStanford University · US

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
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 TR001085NCATS NIH HHS UL1 TR003142NIDDK NIH HHS K23 DK111995
6 · The paper itself

Abstract

BACKGROUND &

aimsLittle is known about the effects of discontinuing mesalamine therapy for patients with Crohn's disease (CD) who initiate therapy with an anti-tumor necrosis factor (anti-TNF) agent. We analyzed data from 2 national population cohorts to compare outcomes of patients with CD already on mesalamine therapy who started treatment with an anti-TNF agent and then either stopped or continued mesalamine.

methodsThe primary outcome was any adverse clinical event, defined as a composite of new corticosteroid use or CD-related hospitalization or surgery. We collected data from the Truven MarketScan (IBM, Armonk, NY) health claims database in the United States and the Danish health registers. Our analysis included patients with CD who started anti-TNF therapy after at least 90 days of oral mesalamine therapy. Patients were classified as stopping mesalamine if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors, and health care utilization. Adjusted hazard ratios with 95% CIs were calculated, comparing stopping mesalamine with continuing mesalamine.

resultsA total of 3178 patients with CD were included in our final analysis (2960 in the United States and 218 in Denmark). Stopping mesalamine after initiating anti-TNF therapy was not associated with an increased risk of adverse clinical events in the US cohort (adjusted hazard ratio, 0.89; 95% CI, 0.77-1.03; P = .13) or in the Danish cohort (adjusted hazard ratio, 1.13; 95% CI, 0.68-1.87; P = .63). Similar results were obtained from sensitivity analyses of concomitant immunomodulator use and duration of mesalamine treatment before initiation of anti-TNF therapy.

conclusionsIn a retrospective analysis of 2 national databases, we found that stopping mesalamine therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events. These results should be validated in a prospective study.

Indexed as

Crohn DiseaseMesalamineBiological TherapyHumansRetrospective StudiesTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsUnited StatesMesalamineTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsIBD TreatmentInflammatory Bowel DiseaseMesalamine

Identifiers

PMID31419574
PMCPMC7015801
OpenAlexW2968853418

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.