Evidence map›Paper›PMID 39610981›Full record

ArticleTherapeutic advances in musculoskeletal disease2024

Switching from rituximab originator to GP2013 or CT-P10 biosimilars in autoimmune rheumatic diseases: drug retention rate and safety data from a multicentric retrospective cohort.

Stefano Gentileschi, Cosimo Bruni, Carla Gaggiano, Roberto D'Alessandro, Giovanni Pacini, Jurgen Sota, Serena Guiducci, Marco Matucci Cerinic, Bruno Frediani

Abstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

9 authors.

Stefano GentileschiRheumatology Unit of Azienda Ospedaliero-Universitaria Senese, Department of Medicine, Surgery and Neurosciences, University of Siena, viale Mario Bracci 16, Siena 53100, Italy.ORCID https://orcid.org/0000-0001-6658-1037
Cosimo BruniDepartment of Experimental and Clinical Medicine, Division of Rheumatology, Careggi University Hospital - University of Florence, Florence, Italy.ORCID https://orcid.org/0000-0003-2813-2083
Carla GaggianoDepartment of Medicine, Surgery and Neurosciences, Rheumatology Unit of Azienda Ospedaliero-Universitaria Senese, University of Siena, Siena, Italy.
Roberto D'AlessandroDepartment of Medicine, Surgery and Neurosciences, Rheumatology Unit of Azienda Ospedaliero-Universitaria Senese, University of Siena, Siena, Italy.
Giovanni PaciniDepartment of Internal Medicine, San Jacopo Hospital, Pistoia, Italy.
Jurgen SotaDepartment of Medicine, Surgery and Neurosciences, Rheumatology Unit of Azienda Ospedaliero-Universitaria Senese, University of Siena, Siena, Italy.
Serena GuiducciDepartment of Experimental and Clinical Medicine, Division of Rheumatology, Careggi University Hospital - University of Florence, Florence, Italy.
Marco Matucci CerinicUnit of Immunology, Rheumatology, Allergy and Rare diseases (UnIRAR), and Inflammation, fibrosis and ageing initiative (INFLAGE) IRCCS San Raffaele Hospital, Milan, ItalyVita Salute San Raffaele University, Milan, Italy.
Bruno FredianiDepartment of Medicine, Surgery and Neurosciences, Rheumatology Unit of Azienda Ospedaliero-Universitaria Senese, University of Siena, Siena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Real-world evidence supporting a safe and effective transition from rituximab originator (RTX-O) to its biosimilars (RTX-B) in autoimmune rheumatic diseases (ARDs) is still limited. Objectives: The primary aims of this study were to evaluate the long-term persistence of RTX-B after the non-medical switch (NMS) from RTX-O in ARD patients, and to explore the RTX-B safety profile. The secondary aims were to evaluate the impact of different factors on RTX-B drug retention rate (DRR) and to identify any factors associated with RTX-B discontinuation. Design: Retrospective observational study. Methods: We included consecutive ARD patients undergoing NMS from RTX-O to GP2013 or CT-P10 from January 2018 to December 2020. RTX-B DRR was estimated by Kaplan-Meier plot analysis and compared according to different factors by the Log-rank test; the Cox proportional hazard model was used to detect factors associated with RTX-B discontinuation in the first 36 months. Results: We enrolled 181 patients switching to RTX-B: GP2013 in 143 (79.0%) cases and CT-P10 in 38 (21.0%). The estimated DRR for RTX-B was 81.5% at 12 months, 80.6% at 24 months, and 77.4% at 36 months. The incidence of adverse events with RTX-B was 12.6/100 patients/year. In the Log-rank test, no statistically significant differences were observed in the RTX-B DRR according to sex ( Conclusion: NMS to RTX-B is associated with a high chance of retaining the drug for up to 36 months, irrespective of the diagnosis. GP2013 showed a higher retention rate than CT-P10.

Indexed as

biosimilarsCT-P10GP2013non-medical switchretention raterituximab

Identifiers

PMID39610981
PMCPMC11603453

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