The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar

Gionata Fiorino, Natalia Manetti, Alessandro Armuzzi, Ambrogio Orlando, Angela Variola, Stefanos Bonovas, Fabrizio Bossa, Giovanni Maconi, Renata DʼIncà, Paolo Lionetti, Laura Cantoro, Walter Fries, Maria L Annunziata, Francesco Costa, Maria M Terpin, Livia Biancone, Claudio C Cortelezzi, Arnaldo Amato, Sandro Ardizzone, Silvio DaneseLuisa Guidi, Giulia Rizzuto, Arianna Massella, Angelo Andriulli, Alessandro Massari, Greta Lorenzon, Silvia Ghione, Anna Kohn, Agostino Ventra, Vito Annese, PROSIT-BIO Cohort

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease.

METHODS: A prospective, multicenter, cohort study using a structured database.

RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64).

CONCLUSIONS: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.

Original languageEnglish
Pages (from-to)233-243
Number of pages11
JournalInflammatory Bowel Diseases
Issue number2
Publication statusPublished - Feb 2017


  • Journal Article


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