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Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

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Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers (EN)
Picchio, Marcello
Elisei, Walter
Allegretta, Leonardo
Ferronato, Antonio
Rodinò, Stefano
Lorenzetti, Roberto
Mocci, Giammarco
Luzza, Francesco
Larussa, Tiziana
Ricciardelli, Cristina
Zampaletta, Costantino
Pranzo, Giuseppe
Tursi, Antonio
Faggiani, Roberto
Sebkova, Ladislava
Penna, Antonio
Lauria, Angelo
Della Valle, Nicola
Franceschi, Marilisa
Forti, Giacomo
Piergallini, Simona
Gallina, Sara
info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
2019-06-30
Background The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. Methods Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn’s disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. Results One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. Conclusion This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator. Keywords Biosimilar, CT-P13, Crohn’s disease, infliximab, ulcerative colitis Ann Gastroenterol 2019; 32 (4): 392-399 (EN)
English
Hellenic Society of Gastroenterology (EN)
1792-7463
1108-7471
Annals of Gastroenterology; Volume 32, No 4 (2019); 392 (EN)
Copyright (c) 2019 Annals of Gastroenterology (EN)
Hellenic Society of Gastroenterology
Annals of Gastroenterology
Original Articles



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