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

Antonio Tursi; Giammarco Mocci; Roberto Faggiani; Leonardo Allegretta; Nicola Della Valle; Giacomo Forti; Marilisa Franceschi; Antonio Ferronato; Sara Gallina; Tiziana Larussa; Francesco Luzza; Roberto Lorenzetti; Antonio Penna; Stefano Rodinò; Ladislava Sebkova; Angelo Lauria; Simona Piergallini; Giuseppe Pranzo; Cristina Ricciardelli; Costantino Zampaletta; Walter Elisei; Marcello Picchio

Authors Antonio Tursi, Giammarco Mocci, Roberto Faggiani, Leonardo Allegretta, Nicola Della Valle, Giacomo Forti, Marilisa Franceschi, Antonio Ferronato, Sara Gallina, Tiziana Larussa, Francesco Luzza, Roberto Lorenzetti, Antonio Penna, Stefano Rodinò, Ladislava Sebkova, Angelo Lauria, Simona Piergallini, Giuseppe Pranzo, Cristina Ricciardelli, Costantino Zampaletta, Walter Elisei, Marcello Picchio.

Abstract

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