Evidence map›Paper›PMID 36802176›Full record

ArticleUnited European gastroenterology journal2023

Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort.

Beatriz Gros, Nikolas Plevris, Nathan Constantine-Cooke, Mathew Lyons, Claire O'Hare, Colin Noble, Ian D Arnott, Gareth-Rhys Jones, Charlie W Lees, Lauranne A A P Derikx

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Article in United European gastroenterology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

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

  1. Pooled it
  2. Observational
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  4. Review
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  8. Review
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  10. Review
  11. UEG Journal's impact and vision for the future.United European gastroenterology journal · 2024
    Article
  12. Review
  13. Article
  14. Navigating adalimumab biosimilars: an expert opinion.Journal of comparative effectiveness research · 2023
    Review
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  16. 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.

Beatriz GrosEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.ORCID 0000-0002-5628-313X
Nikolas PlevrisEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.ORCID 0000-0002-3229-8759
Nathan Constantine-CookeMRC Human Genetics Unit, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK.
Mathew LyonsEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Claire O'HareEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Colin NobleEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Ian D ArnottEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Gareth-Rhys JonesEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Charlie W LeesEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Lauranne A A P DerikxEdinburgh IBD Unit, Western General Hospital, Edinburgh, UK.ORCID 0000-0002-4081-8451

Funding

Medical Research Council MR/N013166/1Medical Research Council MR/S034919/1Wellcome Trust
6 · The paper itself

Abstract

backgroundSwitching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021).

objectiveThe primary endpoint of this study was to assess CT-P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety.

methodsWe performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT-P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, C-reactive protein (CRP), faecal calprotectin (FC), IFX trough/antibody levels, and drug survival.

results297 patients (CD n = 196 [66%], ulcerative colitis/inflammatory bowel disease unclassified n = 101, [34%]) were switched (followed-up: 7.5 months [6.8-8.1]). This was the third, second and first IFX switch for 67/297 (22.5%), 138/297 (46.5%) and 92/297 (31%) of the cohort respectively. 90.6% of patients remained on IFX during follow-up. The number of switches was not independently associated with IFX persistence after adjusting for confounders. Clinical (p = 0.77), biochemical (CRP ≤5 mg/ml; p = 0.75) and faecal biomarker (FC<250 µg/g; p = 0.63) remission were comparable at baseline, week 12 and week 24.

conclusionMultiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.

Indexed as

Biosimilar PharmaceuticalsInflammatory Bowel DiseasesAdultCohort StudiesC-Reactive ProteinDrug SubstitutionGastrointestinal AgentsHumansInfliximabLeukocyte L1 Antigen ComplexProspective StudiesBiosimilar PharmaceuticalsC-Reactive ProteinGastrointestinal AgentsInfliximabLeukocyte L1 Antigen Complexbiosimilarinflammatory bowel diseaseinfliximabreal world evidence

Identifiers

PMID36802176
PMCPMC10039791

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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.