Evidence map›Paper›PMID 39289603›Full record

ArticleBMC gastroenterology2024

Evaluation of adverse clinical outcomes in patients with inflammatory bowel disease receiving different sequences of first- and second-line biologic treatments: findings from ROTARY.

Noa Krugliak Cleveland, Sabyasachi Ghosh, Benjamin Chastek, Tim Bancroft, Ninfa Candela, Tao Fan, Kandavadivu Umashankar, David T Rubin

Abstract read
In one paragraph

Article in BMC gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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.

Noa Krugliak ClevelandInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA. Noa.Cleveland@uchospitals.edu.
Sabyasachi GhoshTakeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
Benjamin ChastekOptum, Eden Prairie, MN, USA.
Tim BancroftOptum, Eden Prairie, MN, USA.
Ninfa CandelaTakeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
Tao FanTakeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
Kandavadivu UmashankarTakeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
David T RubinInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with inflammatory bowel disease (IBD) are at risk of developing dysplasia and, subsequently, colorectal cancer (CRC) owing to chronic inflammation. Patients may also experience other severe disease complications, such as hospitalization and surgery. Several biologics are available for the treatment of patients with IBD and some patients require multiple lines of treatment owing to loss of response or tolerability to their prescribed biologic. Previous studies suggest that the choice of initial biologic treatment may impact the outcomes of later treatment lines. In this study, we assessed adverse clinical outcomes in patients with Crohn's disease (CD) or ulcerative colitis (UC) who received different biologic treatment sequences.

methodsROTARY part B was a retrospective cohort study using the Optum® Clinical Database that evaluated the incidences of IBD-related hospitalization, IBD-related surgery, dysplasia, CRC, and infections in patients with CD or UC who received two biologics successively. First-line biologics included adalimumab, infliximab, ustekinumab (CD only), and vedolizumab; second-line biologics included infliximab and adalimumab.

resultsIn patients with CD, the treatment sequence of ustekinumab to infliximab was associated with the highest overall incidences of hospitalization (51.9%), surgery (40.7%), CRC (3.7%), and infection (37.0%). Vedolizumab followed by an anti-tumor necrosis factor alpha (anti-TNFα) treatment was associated with a significantly lower risk of experiencing an adverse medical event (hospitalization, surgery, or infection) than two successive anti-TNFα treatments (odds ratio, 1.526; 95% confidence interval, 1.004-2.320; P < 0.05). In patients with UC, the treatment sequence of vedolizumab to adalimumab resulted in the lowest overall incidence of adverse outcomes (20.3%, 6.3%, 0.0%, 6.3%, and 4.7% for hospitalization, surgery, CRC, dysplasia, and infection, respectively).

conclusionsWe describe differences in adverse clinical outcomes associated with sequencing of biologics in patients with CD or UC and demonstrate favorable results in patients who received vedolizumab as a first-line biologic. These results provide potential guidance to clinicians choosing sequences of biologic treatments in patients with IBD.

Indexed as

AdalimumabAntibodies, Monoclonal, HumanizedColitis, UlcerativeCrohn DiseaseHospitalizationInfliximabUstekinumabAdultBiological ProductsColorectal NeoplasmsFemaleGastrointestinal AgentsHumansInflammatory Bowel DiseasesMaleMiddle AgedAdalimumabAntibodies, Monoclonal, HumanizedBiological ProductsGastrointestinal AgentsInfliximabUstekinumabvedolizumabBiologicsCrohn’s diseaseUlcerative colitis

Identifiers

PMID39289603
PMCPMC11406817

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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.