Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy

Franco Scaldaferri, Alfredo Papa, Antonio Tursi, Daniele Napolitano, Elisa Schiavoni, Laura Turchini, Daniela Pugliese, Luisa Guidi, Lucrezia Laterza, Loris Riccardo Lopetuso, Alessandro Armuzzi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo FortiFederica Gaiani, Maria Giovanna Graziani, Roberto Lorenzetti, Francesco Luzza, Pietro Paese, Antonio Penna, Roberta Pica, Giuseppe Pranzo, Stefano Rodinò, Antonella Scarcelli, Costantino Zampaletta, Lorenzo Brozzi, Clelia Cicerone, Andrea Cocco, Gianluigi De’ Angelis, Laura Donnarumma, Serafina Fiorella, Chiara Iannelli, Tiziana Larussa, Marco Le Grazie, Ileana Luppino, Costantino Meucci, Roberto Faggiani, Cristiano Pagnini, Patrizia Perazzo, Kryssia Isabel Rodriguez-Castro, Rodolfo Sacco, Ladislava Sebkova, Mariaelena Serio, Alberta De Monti, Marcello Picchio, Walter Elisei, Giovanni Maconi

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Background: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy. Research Design and Methods: Three hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint. Results: 197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn’s Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6–36) months were compared: 230 (60.5%) were naïve to anti-TNFα, 20 (5.26%) were switched from IFX originator or from IFX CT-P13 to IFX SB2. Clinical remission was achieved in 133 (67.5%) UC patients and in 164 (89.6%) CD patients (p < 0.000), with no differences between CT-P13 and SB2 in the rate of remission in UC (p = 0.667) and CD (p = 0.286). Clinical response, steroid-free remission, rate of surgery, mucosal healing (MH) in UC, switching from IFX originator or from other biosimilar, and safety were similar. Higher MH rate was obtained in CD patients treated with CT-P13 (p = 0.004). Conclusion: This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.
Lingua originaleEnglish
pagine (da-a)313-320
Numero di pagine8
RivistaExpert Opinion on Biological Therapy
Volume22
DOI
Stato di pubblicazionePubblicato - 2022

Keywords

  • Antibodies, Monoclonal
  • Biosimilar
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Colitis, Ulcerative
  • Gastrointestinal Agents
  • Humans
  • Inflammatory Bowel Diseases
  • Infliximab
  • Italy
  • Prospective Studies
  • Retrospective Studies
  • SB2
  • Treatment Outcome
  • crohn’s disease
  • infliximab
  • ulcerative colitis

Fingerprint

Entra nei temi di ricerca di 'Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy'. Insieme formano una fingerprint unica.

Cita questo