Evidence map›Paper›PMID 40016953›Full record

ArticleJournal of gastroenterology and hepatology2025

Comparing Long-Term Infliximab Persistence Following a Switch to a Biosimilar in Patients With Inflammatory Bowel Disease: No Cause for Concern.

Paulina Suo, Ashish Srinivasan, Lena Thin, Yoon-Kyo An, Richard G Fernandes, Simon Ghaly, Angus W Jeffrey, Shankar Menon, Nicholas Olsen, Thomas Skinner and 3 more

Abstract readMulticenter StudyComparative Study
In one paragraph

Article in Journal of gastroenterology and hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. 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

13 authors.

Paulina SuoDepartment of Gastroenterology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Ashish SrinivasanDepartment of Gastroenterology, Eastern Health, Melbourne, Australia.
Lena ThinDepartment of Gastroenterology, Fiona Stanley Hospital, Perth, Australia.
Yoon-Kyo AnDepartment of Gastroenterology, Mater Hospital Brisbane, Australia.
Richard G FernandesDepartment of Gastroenterology, Mater Hospital Brisbane, Australia.
Simon GhalyDepartment of Gastroenterology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Angus W JeffreyDepartment of Medicine, University of Western Australia, Perth, Australia.
Shankar MenonDepartment of Gastroenterology, Royal Perth Hospital, Perth, Australia.
Nicholas OlsenStats Central, Mark Wainwright Analytical Centre, UNSW, Sydney, New South Wales, Australia.
Thomas SkinnerDepartment of Gastroenterology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.ORCID https://orcid.org/0000-0001-9276-1955
Daniel R van LangenbergDepartment of Gastroenterology, Eastern Health, Melbourne, Australia.ORCID https://orcid.org/0000-0003-3662-6307
James WinstonDepartment of Gastroenterology, Eastern Health, Melbourne, Australia.
Craig HaiferDepartment of Gastroenterology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.ORCID https://orcid.org/0000-0002-3675-6550

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSeveral studies have demonstrated that switching stable patients with inflammatory bowel disease (IBD) from originator to biosimilar infliximab is noninferior to continuing originator infliximab. However, "real-world" data comparing long-term outcomes between switch and nonswitch cohorts is lacking. This study aimed to address this gap by comparing long-term outcomes in IBD patients across switch and nonswitch cohorts.

methodsThe SAME study was a multicenter, prospective parallel cohort noninferiority study, that enrolled Australian IBD patients in steroid-free clinical remission on maintenance originator infliximab, who either continued originator infliximab (n = 141) or switched to biosimilar (CT-P13) infliximab (n = 204). Here, we present long-term outcomes, with treatment persistence beyond 48 weeks as the primary outcome. Disease worsening, defined as any of infliximab discontinuation, dose escalation, antibody development, or adverse event, were secondary outcomes of interest.

resultsOf 345 patients enrolled in the SAME study, 320 (92.7%) patients were followed up beyond 48 weeks (median: 54.2 months [IQR 46.1-59.3]). There were no differences in infliximab discontinuation between switch and nonswitch cohorts (35.3% vs. 37.6%, p = 0.47). Infliximab discontinuation due to disease worsening (21.7% vs. 23.6%), dose escalation (35.2% vs. 32.4%), antibody development (5.3% vs. 11.3%), and infliximab-related adverse events (7.8% vs. 8.3%), were also comparable (all p > 0.70) between switch and nonswitch cohorts.

conclusionsLong-term infliximab persistence was similar between switch and nonswitch cohorts over 4 years of follow-up. These data represent the longest duration of "real-world" follow-up, and should provide further reassurance that nonmedical switching is safe and clinically comparable to ongoing originator infliximab in clinically stable patients with IBD.

Indexed as

Antibodies, MonoclonalBiosimilar PharmaceuticalsDrug SubstitutionGastrointestinal AgentsInflammatory Bowel DiseasesInfliximabAdultAustraliaFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesTime FactorsTreatment OutcomeAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13Gastrointestinal AgentsInfliximabclinical intestinal disordersclinical trialsgastroenterologyIBDpharmacokinetics

Identifiers

PMID40016953
PMCPMC12062915

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Registered trials

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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.