Evidence map›Paper›PMID 34523800›Full record

ArticleClinical and translational science2022

Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study.

Stefano Mazza, Nicole Piazza O Sed, Francesco Simone Conforti, Alberto Fascì, Alessandro Rimondi, Beatrice Marinoni, Valentina Casini, Chiara Ricci, Francesca Munari, Lorena Pirola and 12 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Pooled it
  3. Observational
  4. Relapse of retinal vasculitis after a non-medical biosimilar switch: a case report.Journal of ophthalmic inflammation and infection · 2026
    Article
  5. Review
  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. Observational
  11. Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Observational
  17. Article
  18. 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

22 authors at 11 institutions in 3 countries.

Stefano MazzaFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Nicole Piazza O SedFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Francesco Simone ConfortiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Alberto FascìFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Alessandro RimondiDepartment of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
Beatrice MarinoniDepartment of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
Valentina CasiniGastroenterology Unit, Bolognini Hospital, Bergamo, Italy.
Chiara RicciDepartment of Clinical and Experimental Sciences, University of Brescia, Spedali Civili, Brescia, Italy.
Francesca MunariGastroenterology Unit, Bolognini Hospital, Bergamo, Italy.
Lorena PirolaDivision of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
Pietro InvernizziDivision of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
Carlo GirelliGastroenterology and Digestive Endoscopy Unit, Busto Arsizio Hospital, Varese, Italy.
Guido LupinacciGastroenterology and Endoscopy Unit, Ospedale Maggiore, Crema, Italy.
Luca PastorelliGastroenterology and Liver Unit, ASST Santi Paolo e Carlo, Ospedale San Paolo Milan, Italy.
Flaminia CavallaroFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Luca FerrarisGastroenterology and Endoscopy Unit, Gallarate Hospital, Varese, Italy.
Alice ColucciGastroenterology and Endoscopy Unit, Gallarate Hospital, Varese, Italy.
Arnaldo AmatoGastroenterology and Digestive Endoscopy Unit, Valduce Hospital, Como, Italy.
Gian Eugenio TontiniFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Maurizio VecchiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Gionata FiorinoIBD Center, Humanitas Clinical and Research Center, Milan, Italy.
Flavio CaprioliFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITUniversity of Milan · ITAzienda Ospedaliera Bolognini Seriate · ITAzienda Ospedaliera San Gerardo · ITAzienda Ospedaliera Sant’Antonio Abate di Gallarate · ITAzienda Ospedaliera Ospedale Maggiore · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITHumanitas University · ITOspedale di Circolo di Busto Arsizio · ITOspedale San Paolo · ITOspedale Valduce · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Indexed as

Drug SubstitutionTreatment OutcomeAdolescentAdultAntibodies, MonoclonalBiosimilar PharmaceuticalsCohort StudiesFemaleHumansInflammatory Bowel DiseasesInfliximabMaleYoung AdultAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13InfliximabSB2 infliximab

Identifiers

PMID34523800
PMCPMC8742653
OpenAlexW3199360383

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.