Evidence map›Paper›PMID 30891808›Full record

Trial reportAlimentary pharmacology & therapeutics2019

Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT.

Siddharth Singh, Larry W Stitt, Guangyong Zou, Reena Khanna, Parambir S Dulai, William J Sandborn, Brian G Feagan, Vipul Jairath

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01030809 (A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT01030809 phase4completednot on this map

A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease

TypeinterventionalSponsorUniversity of Western Ontario, CanadaRan2010 to 2013Enrolled1,999ConditionsCrohn's DiseaseArmsTreatment Algorithm for Crohn's Disease
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Progression of Elderly Onset Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis of Population-Based Cohort Studies.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Pooled it
  2. Trial
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  4. Observational
  5. Review
  6. Article
  7. Review
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  13. The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations-IBD in Seniors.Journal of the Canadian Association of Gastroenterology · 2023
    Review
  14. Article
  15. Review
  16. Article
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  18. Frailty Is Independently Associated with Mortality and Readmission in Hospitalized Patients with Inflammatory Bowel Diseases.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-2640-7269
Larry W StittRobarts Research Institute, London, Ontario, Canada.
Guangyong ZouRobarts Research Institute, London, Ontario, Canada.
Reena KhannaRobarts Research Institute, London, Ontario, Canada.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-9514-2321
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California.ORCID 0000-0002-3314-7960
Brian G FeaganRobarts Research Institute, London, Ontario, Canada.ORCID 0000-0002-6914-3822
Vipul JairathRobarts Research Institute, London, Ontario, Canada.ORCID 0000-0002-1092-0033
University of California San Diego · USWestern University · CARobarts Clinical Trials · CAUniversity Hospital · CA

Funding

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
American College of Gastroenterology Junior Faculty Development #144271Crohn's and Colitis Foundation Career Development #404614NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

backgroundPhysicians may be reluctant to prescribe combined immunosuppression in older patients with Crohn's disease due to perceived risk of treatment-related complications.

aimTo evaluate the impact of age on risk of Crohn's disease-related complications in patients treated with early combined immunosuppression vs conventional management in a post hoc analysis of the randomised evaluation of an algorithm for Crohn's treatment (REACT), a cluster-randomised trial.

methodsWe compared efficacy (time to major adverse outcome of Crohn's disease-related surgery, hospitalisation or serious complications; corticosteroid-free clinical remission) and safety outcomes at 24 months, between patients aged <60 vs ≥60 years randomised to early combined immunosuppression or conventional management, using Cox proportional hazard analysis or modified Poisson model. In the early combined immunosuppression arm, patients with failure to achieve clinical remission within 4-12 weeks of corticosteroids were treated with a combination of tumour necrosis factor-α antagonist plus anti-metabolite and sequentially escalated in a stepwise algorithm.

resultsOf 1981 patients, 311 were ≥60 years (15.7%; 173 randomised to early combined immunosuppression and 138 to conventional management). Over 24 months, 10% of older patients developed Crohn's disease-related complications (early combined immunosuppression vs conventional management: 6.4% vs 14.5%) and 14 patients died (3.5% vs 5.8%). There was no difference between younger and older patients in risk of achieving corticosteroid-free clinical remission (<60 years, early combined immunosuppression (72.6%) vs conventional management (64.4%): relative risk [RR], 1.06 [95% CI, 0.98-1.15] vs ≥60 years, early combined immunosuppression (74.8%) vs conventional management (63.0%): RR, 1.09 [0.90-1.33], P-interaction = 0.78) or time to major adverse outcome (<60 years: hazard ratio [HR], 0.71 [0.53-0.96] vs ≥60 years: HR, 0.69 [0.31-1.51], P-interaction = 0.92) with early combined immunosuppression vs conventional management.

conclusionsWe observed no difference in efficacy and safety of early combined immunosuppression compared to conventional management in older and younger patients. Early combined immunosuppression may be considered as a treatment option in selected older patients with Crohn's disease with suboptimal disease control. Clinical Trial Identifier: NCT01030809.

Indexed as

Immunosuppression TherapyAdrenal Cortex HormonesAdultAgedAged, 80 and overAge FactorsAntimetabolitesCrohn DiseaseDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMaleMiddle AgedRemission InductionAdrenal Cortex HormonesAntimetabolitesImmunosuppressive AgentsTNF protein, humanTumor Necrosis Factor-alpha

Identifiers

PMID30891808
PMCPMC6461484
OpenAlexW2923519186

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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.