The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar. Issue 2 (13th January 2017)

• Record Type: Journal Article
• Authors: Fiorino, Gionata; Manetti, Natalia; Armuzzi, Alessandro; Orlando, Ambrogio; Variola, Angela; Bonovas, Stefanos; Bossa, Fabrizio; Maconi, Giovanni; D'Incà, Renata; Lionetti, Paolo; Cantoro, Laura; Fries, Walter; Annunziata, Maria L.; Costa, Francesco; Terpin, Maria M.; Biancone, Livia; Cortelezzi, Claudio C.; Amato, Arnaldo; Ardizzone, Sandro; Danese, Silvio; Guidi, Luisa; Rizzuto, Giulia; Massella, Arianna; Andriulli, Angelo; Massari, Alessandro; Lorenzon, Greta; Ghione, Silvia; Kohn, Anna; Ventra, Agostino; Annese, Vito
• Is Part Of: Inflammatory bowel diseases. Volume 23:Issue 2(2017)
• Page Start: 233
• Page End: 243
• Publication Date: 2017-01-13
• Subjects: Crohn's disease -- ulcerative colitis -- inflammatory bowel disease -- Infliximab -- Remsima -- Inflectra -- biosimilar -- CT-P13; Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1097/MIB.0000000000000995
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract : Article first published online 13 January 2017. Abstract : 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.