Evidence map›Paper›PMID 30344642›Full record

ArticleTherapeutic advances in gastroenterology2018

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease.

Viktoria Bergqvist, Mohammad Kadivar, Daniel Molin, Leif Angelison, Per Hammarlund, Marie Olin, Jörgen Torp, Olof Grip, Stefan Nilson, Erik Hertervig and 2 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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.

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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Article
  5. An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024
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  17. Observational
  18. Infliximab in inflammatory bowel disease.Therapeutic advances in chronic disease · 2019
    Review
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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

12 authors at 3 institutions in 1 country.

Viktoria BergqvistDepartment of Gastroenterology, Skåne University Hospital, Lund/Malmö, Sweden.
Mohammad KadivarImmunology Section, Department of Experimental Medical Science, Lund University, Lund, Sweden.
Daniel MolinSection of Medicine, Department of Clinical Sciences, Lund University, Lund, Sweden.
Leif AngelisonSection of Medicine, Department of Clinical Sciences, Lund University, Lund, Sweden.
Per HammarlundDepartment of Internal Medicine, Ängelholm Hospital, Ängelholm, Sweden.
Marie OlinDepartment of Internal Medicine, Helsingborg Hospital, Helsingborg, Sweden.
Jörgen TorpDepartment of Internal Medicine, Central Hospital of Kristianstad, Kristianstad, Sweden.
Olof GripDepartment of Gastroenterology, Skåne University Hospital, Lund/Malmö, Sweden.
Stefan NilsonDepartment of Internal Medicine, Central Hospital of Kristianstad, Kristianstad, Sweden.
Erik HertervigDepartment of Gastroenterology, Skåne University Hospital, Lund/Malmö, Sweden.
Jan LillienauDepartment of Gastroenterology, Skåne University Hospital, Lund/Malmö, Sweden.
Jan Marsali) Department of Gastroenterology, Skåne University Hospital, S-22185 Lund, Sweden.ORCID https://orcid.org/0000-0003-4808-0014
Lund University · SEKristianstad University · SEHelsingborgs lasarett · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn's disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13.

methodsIn this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events.

resultsA total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events.

conclusionsThis is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

Indexed as

biosimilarCrohn’s diseaseinfliximabswitchulcerative colitis

Identifiers

PMID30344642
PMCPMC6187418
OpenAlexW2896737472

What OpenQuestion holds

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LicenceCC BY-NC
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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.