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

Autor: Stefano Gentileschi, Cosimo Bruni, Carla Gaggiano, Roberto D’Alessandro, Giovanni Pacini, Jurgen Sota, Serena Guiducci, Marco Matucci Cerinic, Bruno Frediani
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Therapeutic Advances in Musculoskeletal Disease, Vol 16 (2024)
Druh dokumentu: article
ISSN: 1759-7218
1759720X
DOI: 10.1177/1759720X241292312
Popis: 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 ( p = 0.171), ARD diagnosis ( p = 0.281), and concomitant immunosuppressive therapy ( p = 0.054); on the contrary, patients on GP2013 showed a higher DRR than those on CT-P10 ( p
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