TY - JOUR
T1 - 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
AU - Tursi, Antonio
AU - Mocci, Giammarco
AU - Allegretta, Leonardo
AU - Aragona, Giovanni
AU - Bianco, Maria Antonia
AU - Colucci, Raffaele
AU - Cuomo, Antonio
AU - Della Valle, Nicola
AU - Ferronato, Antonio
AU - Forti, Giacomo
AU - Gaiani, Federica
AU - Graziani, Maria Giovanna
AU - Lorenzetti, Roberto
AU - Luzza, Francesco
AU - Paese, Pietro
AU - Penna, Antonio
AU - Pica, Roberta
AU - Pranzo, Giuseppe
AU - Rodinò, Stefano
AU - Scarcelli, Antonella
AU - Zampaletta, Costantino
AU - Brozzi, Lorenzo
AU - Cicerone, Clelia
AU - Cocco, Andrea
AU - De’ Angelis, Gianluigi
AU - Donnarumma, Laura
AU - Fiorella, Serafina
AU - Iannelli, Chiara
AU - Larussa, Tiziana
AU - Le Grazie, Marco
AU - Luppino, Ileana
AU - Meucci, Costantino
AU - Faggiani, Roberto
AU - Pagnini, Cristiano
AU - Perazzo, Patrizia
AU - Rodriguez-Castro, Kryssia Isabel
AU - Sacco, Rodolfo
AU - Sebkova, Ladislava
AU - Serio, Mariaelena
AU - De Monti, Alberta
AU - Picchio, Marcello
AU - Napolitano, Daniele
AU - Schiavoni, Elisa
AU - Turchini, Laura
AU - Scaldaferri, Franco
AU - Pugliese, Daniela
AU - Guidi, Luisa
AU - Laterza, Lucrezia
AU - Privitera, Giuseppe
AU - Pizzoferrato, Marco
AU - Lopetuso, Loris Riccardo
AU - Armuzzi, Alessandro
AU - Elisei, Walter
AU - Maconi, Giovanni
AU - Papa, Alfredo
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Antibodies, Monoclonal
KW - Biosimilar
KW - Biosimilar Pharmaceuticals
KW - CT-P13
KW - Colitis, Ulcerative
KW - Gastrointestinal Agents
KW - Humans
KW - Inflammatory Bowel Diseases
KW - Infliximab
KW - Italy
KW - Prospective Studies
KW - Retrospective Studies
KW - SB2
KW - Treatment Outcome
KW - crohn’s disease
KW - infliximab
KW - ulcerative colitis
KW - Antibodies, Monoclonal
KW - Biosimilar
KW - Biosimilar Pharmaceuticals
KW - CT-P13
KW - Colitis, Ulcerative
KW - Gastrointestinal Agents
KW - Humans
KW - Inflammatory Bowel Diseases
KW - Infliximab
KW - Italy
KW - Prospective Studies
KW - Retrospective Studies
KW - SB2
KW - Treatment Outcome
KW - crohn’s disease
KW - infliximab
KW - ulcerative colitis
UR - http://hdl.handle.net/10807/199329
U2 - 10.1080/14712598.2022.2007881
DO - 10.1080/14712598.2022.2007881
M3 - Article
SN - 1471-2598
VL - 22
SP - 313
EP - 320
JO - Expert Opinion on Biological Therapy
JF - Expert Opinion on Biological Therapy
ER -