Comparison of original and biosimilar infliximab (CTP-13) in biologic-naïve patients with Crohn’s disease and ulcerative colitisa retrospective, multicenter real-life study in Spain

  1. Helena Martínez-Lozano 1
  2. José Miranda-Bautista 1
  3. Yago González-Lama 2
  4. Daniel Carpio 3
  5. Manuel Barreiro-de Acosta
  6. José L. Pérez-Calle
  7. Lucía Relea Pérez 2
  8. Keyla Villa 2
  9. Virginia Matallana 2
  10. Marta Calvo 2
  11. María I. Vera 2
  12. Pablo Pérez Galindo 3
  13. Natalia Mora-Cuadrado 4
  14. Pilar López-Serrano 5
  15. Ignacio Marín-Jiménez 1
  16. Luis Menchén 1
  1. 1 Hospital General Universitario Gregorio Marañón
    info
    Hospital General Universitario Gregorio Marañón

    Madrid, España

    ROR https://ror.org/0111es613

    Erakundearen kokapen geografikoa Hospital General Universitario Gregorio Marañón
  2. 2 Hospital Universitario Puerta de Hierro
    info
    Hospital Universitario Puerta de Hierro

    Madrid, España

    ROR https://ror.org/01e57nb43

    Erakundearen kokapen geografikoa Hospital Universitario Puerta de Hierro
  3. 3 Complexo Hospitalario Universitario de Pontevedra
    info
    Complexo Hospitalario Universitario de Pontevedra

    Pontevedra, España

    ROR https://ror.org/016cxc226

    Erakundearen kokapen geografikoa Complexo Hospitalario Universitario de Pontevedra
  4. 4 Complexo Hospitalario Universitario de Santiago
    info
    Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, España

    ROR https://ror.org/00mpdg388

    Erakundearen kokapen geografikoa Complexo Hospitalario Universitario de Santiago
  5. 5 Hospital Universitario Fundación de Alcorcón. Alcorcón, Madrid. Spain
Erakutsi afiliazioak +
Aldizkaria:
Revista Española de Enfermedades Digestivas

ISSN: 2340-4167,  1130-0108

Argitalpen urtea: 2021

Alea: 113

Zenbakia: 3

Orrialdeak: 170-178

Mota: Artikulua

DOI: 10.17235/REED.2020.6847/2019 DIALNET GOOGLE SCHOLAR lock_openSarbide irekia editor

Beste argitalpen batzuk: Revista Española de Enfermedades Digestivas

Garapen Iraunkorreko Helburuak

Laburpena

Purpose: biosimilar infliximab (CTP-13) has been recently approved for the treatment of several immune-mediated inflammatory disorders, including inflammatory bowel disease (IBD). Comparative studies between this biosimilar and original infliximab in the real clinical practice are scarce. The objective of this study was to compare short and long-term safety and efficacy of original (O) and biosimilar infliximab (B-IFX) in biologic-naïve, IBD patients in the real life clinical practice. Methods: a retrospective, multicentric study was performed in five Spanish hospitals. Consecutive IBD, biologic-naïve patients from an historic cohort who initiated O-IFX from January 2013 were compared with biologic-naïve patients, who started treatment with B-IFX since its approval in January 2015. The evaluation of efficacy was assessed after the induction phase, at week 14 and week 54 of treatment. Time to dose escalation or treatment persistence of both O-IFX and B-IFX was also considered. The appearance of serious adverse events was recorded. Results: two hundred and thirty-nine IBD biologic-naïve patients who started with O-IFX or B-IFX were included: 153 patients were diagnosed with Crohn’s disease (95 treated with O- and 58 treated with B-IFX) and 86 with ulcerative colitis (40 received O- and 46 received B-IFX). At weeks 14 and 54, both O-IFX and B-IFX groups reached a similar clinical response and remission rates. Time to dose escalation, treatment persistence and safety profile were comparable between both groups. Conclusions: this long-term real-life experience provides additional evidence of the similarity of O- and B-IFX CTP-13 in terms of efficacy and safety in IBD patients.

Datuen iturria: Dialnet