Evidence map›Paper›PMID 30581277›Full record

Observational studyWorld journal of gastroenterology2018

Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease.

María Fernanda Guerra Veloz, Federico Argüelles-Arias, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldan, Raúl Perea Amarillo, Vicente Merino Bohórquez, Miguel Angel Calleja, Ángel Caunedo Álvarez, Ángel Vilches Arenas

Abstract readComparative StudyObservational Study
In one paragraph

Observational study in World journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024
    Article
  4. Observational
  5. Review
  6. Article
  7. Article
  8. Review
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.

María Fernanda Guerra VelozDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Federico Argüelles-AriasDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain. farguelles@telefonica.net.
Luisa Castro LariaDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Belén Maldonado PérezDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Antonio Benítez RoldanDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Raúl Perea AmarilloDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Vicente Merino BohórquezPharmacy Unit, University Hospital Virgen Macarena, Seville 41007, Spain.
Miguel Angel CallejaPharmacy Unit, University Hospital Virgen Macarena, Seville 41007, Spain.
Ángel Caunedo ÁlvarezDepartment of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain.
Ángel Vilches ArenasPreventive Medicine and Public Health, University Hospital Virgen Macarena, Seville 41007, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited.

aimTo compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.

methodsAn observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.

results98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71%

conclusionThe overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

Indexed as

AdultAntibodies, MonoclonalBiosimilar PharmaceuticalsDrug SubstitutionFemaleFollow-Up StudiesGastrointestinal AgentsHumansInflammatory Bowel DiseasesInfliximabMaleMiddle AgedProspective StudiesRemission InductionRetrospective StudiesTreatment OutcomeAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13Gastrointestinal AgentsInfliximabBiosimilar agentCrohn’s diseaseCT-P13EfficacyInflammatory bowel diseaseInfliximab originalUlcerative colitis

Identifiers

PMID30581277
PMCPMC6295832

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.