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

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 Riccardo Lopetuso; Alessandro Armuzzi; Walter Elisei; Giovanni Maconi; Alfredo Papa

doi:10.1080/14712598.2022.2007881

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

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 Riccardo Lopetuso, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi, Alfredo Papa

AO Brotzu
Santa Caterina Novella Hospital
Ospedale Guglielmo da Saliceto
T. Maresca Hospital
Ospedale San Matteo degli Infermi
“Umberto I” Hospital
“Ospedali Riuniti” Hospital
ULSS7 Pedemontana
Santa Maria Goretti Hospital
University of Parma
Complesso Ospedaliero San Giovanni - Addolorata
“Nuovo Regina Margherita” Territorial Hospital
Magna Græcia University
Annunziata Hospital
Asl Ba
ASL Roma 2
“Valle D’Itria” Hospital
Azienda Ospedaliera Pugliese-Ciaccio
Azienda Ospedaliera San Salvatore di Pesaro
Ospedale di Belcolle - Viterbo
“P. Pio” Hospital
San Camillo Hospital
University of Milan
"P. Colombo" Hospital

Research output: Contribution to journal › Article

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.

Original language	English
Pages (from-to)	313-320
Number of pages	8
Journal	Expert Opinion on Biological Therapy
Volume	22
DOIs	https://doi.org/10.1080/14712598.2022.2007881
Publication status	Published - 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

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10.1080/14712598.2022.2007881

Cite this

Tursi, A., Mocci, G., Allegretta, L., Aragona, G., Bianco, M. A., Colucci, R., Cuomo, A., Della Valle, N., Ferronato, A., Forti, G., Gaiani, F., Graziani, M. G., Lorenzetti, R., Luzza, F., Paese, P., Penna, A., Pica, R., Pranzo, G., Rodinò, S., ... Papa, A. (2022). 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. Expert Opinion on Biological Therapy, 22, 313-320. https://doi.org/10.1080/14712598.2022.2007881

@article{9403096743de4b779f33765f48581b02,

title = "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{\textquoteright}s Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6{\textendash}36) months were compared: 230 (60.5\%) were na{\"i}ve 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.",

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{\textquoteright}s disease, infliximab, ulcerative colitis, 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{\textquoteright}s disease, infliximab, ulcerative colitis",

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

year = "2022",

doi = "10.1080/14712598.2022.2007881",

language = "English",

volume = "22",

pages = "313--320",

journal = "Expert Opinion on Biological Therapy",

issn = "1471-2598",

publisher = "Taylor and Francis Ltd.",

}

Tursi, A, Mocci, G, Allegretta, L, Aragona, G, Bianco, MA, Colucci, R, Cuomo, A, Della Valle, N, Ferronato, A, Forti, G, Gaiani, F, Graziani, MG, Lorenzetti, R, Luzza, F, Paese, P, Penna, A, Pica, R, Pranzo, G, Rodinò, S, Scarcelli, A, Zampaletta, C, Brozzi, L, Cicerone, C, Cocco, A, De’ Angelis, G, Donnarumma, L, Fiorella, S, Iannelli, C, Larussa, T, Le Grazie, M, Luppino, I, Meucci, C, Faggiani, R, Pagnini, C, Perazzo, P, Rodriguez-Castro, KI, Sacco, R, Sebkova, L, Serio, M, De Monti, A, Picchio, M, Napolitano, D, Schiavoni, E, Turchini, L, Scaldaferri, F, Pugliese, D, Guidi, L, Laterza, L, Privitera, G, Pizzoferrato, M, Lopetuso, LR, Armuzzi, A, Elisei, W, Maconi, G & Papa, A 2022, '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', Expert Opinion on Biological Therapy, vol. 22, pp. 313-320. https://doi.org/10.1080/14712598.2022.2007881

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 -

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

Keywords

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