Evidence map›Paper›PMID 31258621›Full record

ArticleTherapeutic advances in gastroenterology2019

Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data.

María Fernanda Guerra Veloz, María Belvis Jiménez, Teresa Valdes Delgado, Luisa Castro Laria, Belén Maldonado Pérez, Raúl Perea Amarillo, Vicente Merino Bohórquez, Ángel Caunedo Álvarez, Ángel Vilches Arenas, Federico Argüelles-Arias

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 27% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

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

María Fernanda Guerra VelozGastroenterology Department, University Hospital Virgen Macarena, C/ Dr. Fedriani 3, Seville, 41007, Spain.ORCID https://orcid.org/0000-0001-9708-8245
María Belvis JiménezGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Teresa Valdes DelgadoGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Luisa Castro LariaGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Belén Maldonado PérezGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Raúl Perea AmarilloGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Vicente Merino BohórquezPharmacy Unit, University Hospital Virgen Macarena, Seville, Spain.
Ángel Caunedo ÁlvarezGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Ángel Vilches ArenasPreventive Medicine and Public Health, University Hospital Virgen Macarena, Seville, Spain.
Federico Argüelles-AriasGastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Hospital Universitario Virgen Macarena · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease.

methodsThis was a prospective single-center observational study involving patients with moderate-to-severe Crohn's disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey-Bradshaw (HB) index and partial Mayo score for patients with Crohn's disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study.

resultsA total of 64 patients with Crohn's disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies.

conclusionsMost of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.

Indexed as

Crohn’s diseaseCT-P13ulcerative colitis

Identifiers

PMID31258621
PMCPMC6585238
OpenAlexW2952464799

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.