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.

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.

• Authors: Antonio Tursi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo Forti, Federica 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, Daniele Napolitano, Elisa Schiavoni, Laura Turchini, Franco Scaldaferri, Daniela Pugliese, Luisa Guidi, Lucrezia Laterza, Giuseppe Privitera, Marco Pizzoferrato, Loris R Lopetuso, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi, Alfredo Papa
• Journal: Expert opinion on biological therapy (Expert Opin Biol Ther) Vol. 22 Issue 2 Pg. 313-320 (Feb 2022) ISSN: 1744-7682 [Electronic] England
• PMID: 34904510 (Publication Type: Journal Article, Multicenter Study, Observational Study)

Chemical References

• Antibodies, Monoclonal
• Biosimilar Pharmaceuticals
• CT-P13
• Gastrointestinal Agents
• Infliximab

Topics

• Antibodies, Monoclonal
• Biosimilar Pharmaceuticals (adverse effects)
• Colitis, Ulcerative (drug therapy)
• Gastrointestinal Agents (adverse effects)
• Humans
• Inflammatory Bowel Diseases (drug therapy)
• Infliximab (therapeutic use)
• Italy
• Prospective Studies
• Retrospective Studies
• Treatment Outcome