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.

KEYWORDS:

• Biosimilar
• crohn’s disease
• CT-P13
• infliximab
• SB2
• ulcerative colitis

Declaration of Interests

Alessandro Armuzzi received consulting and/or advisory board fees from AbbVie, Allergan, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Ferring, Janssen, Lilly, MSD, Mylan, Pfizer, Samsung Bioepis, Sandoz, Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Biogen, Ferring, Janssen, MSD, Mitsubishi-Tanabe, Nikkiso, Pfizer, Sandoz, Samsung Bioepis, Takeda; and research grants from MSD, Pfizer, Takeda. Giovanni Maconi served as speaker and/or advisory board fees for AlfaSigma, Arena, Janssen, Gilead, Roche. Giuseppe Privitera received consultancies fee from AlfaSigma. Daniela Pugliese received speaker fees from AbbVie, MSD, Takeda, Janssen, Pfizer. Franco Scaldaferri served as lecturer for Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author contributions

Conception and design: Antonio TURSI, Alfredo PAPA;

Acquisition and collection of data: 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 RODINO’, 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;

Analysis and interpretation of data: Antonio TURSI, Walter ELISEI, Marcello PICCHIO, Giovanni MACONI, Alfredo PAPA;

drafting of the paper or revising it critically for intellectual content: Antonio TURSI, Walter ELISEI, Marcello PICCHIO, Giovanni MACONI, Alfredo PAPA;

Final approval of the version to be published: 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 RODINO’, 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.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This study was not funded.