Evidence map›Paper›PMID 30535885›Full record

ArticleDigestive diseases and sciences2019

Implementation of CT-P13 via a Managed Switch Programme in Crohn's Disease: 12-Month Real-World Outcomes.

Nikolas Plevris, Gareth R Jones, Philip W Jenkinson, Mathew Lyons, Cher S Chuah, Lynne M Merchant, Rebecca J Pattenden, Eleanor F Watson, Gwo-Tzer Ho, Colin L Noble and 4 more

Abstract readEvaluation Study
PubMed Publisher
In one paragraph

Article in Digestive diseases and sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 5 pooled it
3.6field-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.

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

19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024
    Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  12. Observational
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Biosimilars in IBD: Similarity Breeds Contented Patients.Digestive diseases and sciences · 2019
    Article
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Nikolas PlevrisThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK. nikolas.plevris@nhslothian.scot.nhs.uk.ORCID http://orcid.org/0000-0002-3229-8759
Gareth R JonesThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Philip W JenkinsonThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Mathew LyonsThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Cher S ChuahThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Lynne M MerchantThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Rebecca J PattendenDepartment of Clinical Biochemistry, Western General Hospital, Edinburgh, EH4 2XU, UK.
Eleanor F WatsonThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Gwo-Tzer HoThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Colin L NobleThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Shahida DinThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Alan G ShandThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Ian D ArnottThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Charlie W LeesThe Edinburgh IBD Unit, Western General Hospital, Edinburgh, EH4 2XU, UK.
Western General Hospital · GB

Funding

Medical Research Council G0701898Medical Research Council MR/S034919/1
6 · The paper itself

Abstract

backgroundSwitching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn's disease.

aimThe aim of this work was to prospectively evaluate clinical outcomes in a cohort of patients with Crohn's disease switching from Remicade to CT-P13.

methodsA prospective service evaluation was performed. The Harvey-Bradshaw index, CRP, faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients' final Remicade infusion and at 6 and 12 months after switching to CT-P13 as part of routine clinical care. All adverse events during follow-up were also recorded.

resultsOne hundred and ten patients on Remicade switched to CT-P13. No significant difference was observed between the Harvey-Bradshaw Index (p = 0.07), CRP (p = 0.13), faecal calprotectin (p = 0.25) or trough infliximab levels (p = 0.47) comparing before and at 6 and 12 months after the switch to CT-P13. Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13. The majority of patients remained on CT-P13 at 12 months (84.5%) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up, respectively. Switching to CT-P13 resulted in a cost saving of approximately 46.4%.

conclusionThe transition to CT-P13 from Remicade for the treatment of Crohn's disease is safe and has no negative effect on clinical outcomes at 12 months.

Indexed as

Drug SubstitutionAdultAntibodies, MonoclonalAnti-Inflammatory AgentsBiological ProductsBiosimilar PharmaceuticalsCrohn DiseaseDrug Administration ScheduleFemaleHumansInfliximabMaleMiddle AgedProgram EvaluationProspective StudiesTime FactorsAntibodies, MonoclonalAnti-Inflammatory AgentsBiological ProductsBiosimilar PharmaceuticalsCT-P13InfliximabBiosimilarCrohn’s diseaseCT-P13Infliximab

Identifiers

PMID30535885
OpenAlexW2903835603

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.