Data from the PRospective Observational cohort Study on patients with Inflammatory bowel disease receiving Therapy with BIOsimilars (PROSIT-BIO) in patients with ulcerative colitis (UC) and Crohn's disease (CD) has been presented at the Italian Group for the Study of IBD (IG-IBD), VII National Congress, Palermo, Italy.1 The study of 397 patients (174 UC and 223 CD) - the largest of its kind to date - demonstrated that those who were switched from reference infliximab to biosimilar infliximab (93 patients) demonstrated comparable efficacy to those patients receiving a biosimilar who had previously been naïve to anti-TNFα (217 patients) and to those receiving a biosimilar who had previously been exposed to one or more biologics (87 patients) (response rate 95% vs. 92% vs. 91%, respectively).1 Safety was also found to be comparable across the patient groups.1
"These data, even though preliminary, demonstrate in real life that switching patients to biosimilar infliximab from reference infliximab results in comparable outcomes for patients, and that biosimilar infliximab is also effective in those patients who are anti-TNFα naïve or who have previously been exposed to one or more biologics," commented Professor Silvio Danese, Head of the IBD Center, Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy and one of the authors of the study. "The data also show that biosimilar infliximab had a comparable safety profile over the duration of the study. Biosimilars are cost effective options which can help to save money for health systems and these data suggest there is a comparable response and safety profile."
In the study, 93 patients (42 UC and 51 CD) were switched after a mean of 14±13 previous infusions of infliximab (range 1-71), 231 patients received Remsima® and 165 patients received Inflectra®.1 * Biosimilars may represent a cost-effective option for patients and health systems which have limited resources available.
Further switch data on Remsima® is expected from the 'Nor-Switch' study funded by the Norwegian government, with data expected to be reported in 2016. Five hundred patients across all indications will be switched to Remsima® from reference infliximab in this study, with occurrence of disease worsening as the primary endpoint.2
Mundipharma International Limited and its independent associated companies have secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima® in Germany, Italy, UK, Netherlands, Belgium and Luxembourg.
About the PROSIT-BIO study1
The PRospective Observational cohort Study on patients with inflammatory bowel disease receiving Therapy with BIOsimilars (PROSIT-BIO) was conducted in 49 centres in Italy in 397 subjects with IBD. The study included 223 Crohn's disease (CD) and 174 ulcerative colitis (UC) patients. The median age at diagnosis for CD patients was 30.6 ±14.4 years and for UC patients, 38.9±14.3 years. 217 patients were naïve to anti-TNFα (105 CD, 112 UC), 87 patients (67 CD and 20 UC) had a previous exposure to one or more biologic (26 infliximab, 59 adalimumab, 6 golimumab, 2 ustekinumab) and 93 patients (51 CD and 42 UC) were switched after a mean of 14±13 previous infusions of infliximab (range 1-71). There were 1116 infusions: 165 patients received Inflectra® (total number of infusions = 405) and the remaining 231 received Remsima® (total number of infusions = 711). Follow-up was 82.8 years/patient. The primary endpoint was safety at 12 months and the secondary endpoints were efficacy of biosimilars at 12 months, immunogenicity and predictive factors for efficacy and safety.