P493 Comparison of the efficacy of infliximab biosimilar (Remsima®) vs. infliximab original (Remicade®) in patients with inflammatory bowel disease

• Published in: Journal of Crohn's and colitis Vol. 12; no. supplement_1; pp. S354 - S355
• Main Authors: Guerra Veloz, M F, Belvis Jimenez, M, Valdes Delgado, T, Perea Amarillo, R, Castro Laria, L, Maldonado Pérez, B, Merino, V, Benítez Roldán, A, Caunedo Álvarez, A, Argüelles-Arias, F
• Format: Journal Article
• Language: English
• Published: UK Oxford University Press 16.01.2018
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.620

Abstract Background Infliximab have changed the natural history of inflammatory bowel diseases (IBD). However, with the advent of biosimilar treatment such as CT-P13 promises to improve availability of biological therapy. The annual risk of loss infliximab efficacy to be 13–15% per patient/year. The aim of the study is to compare the loss of efficacy of the treatment with Infliximab biosimilar (Remsima®) vs. original Infliximab (Remicade®) in patients with IBD who were “switched” from infliximab original (Remicade®). Methods This was an observational ambispective cohort study of 1 year of follow-up. A cohort (retrospective) constituted by patients with IBD who had a treatment with original Infliximab (Remicade®) in the period of 2014–2015 and another cohort (prospective) constituted by patients whom were switched from infliximab reference (Remicade®) to CT-P13 treatment (Remsima®) in the period of 2015–2016. Baseline characteristics of the patients were analysed, as well as the loss of response in both periods after 12 months of treatment. The activity of the disease was evaluated at 0 and 12 months, according to the Harvey Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Results The Baseline demographics and phenotypic characteristics of patients with CD and UC, according to the Montreal Classification, are shown in Table 1. Baseline demographics and phenotypic characteristics according to the Montreal classification. Prospective cohort, 98 patients with IBD were included (67 CD/31 CU), 56.1% men, 68.3% non-smokers. 83.6% (56 of 67) of the patients with CD were in remission at the time of the change and 67.7% (42 of 62) at 12 months. In patients with UC, 80.6% (25 of 31) were in remission at the time of the change and 69, 2% (18 of 26) at 12 months. In the retrospective cohort, 98 patients with IBD were included (67 CD/31 CU), 58.2% men, 68.3% non-smokers. 76.1% (51 of 67) of the patients with CD were in initial remission and 68.7% (46 of 67) at 12 months. In patients with UC, 83.9% (26 of 31) were in initial remission and 77.4% (24 of 31) at 12 months. When the loss of efficacy was compared in both periods, no statistically significant differences were observed (p > 0.5). Comparative results of the efficacy Remicade group vs. CT-P13. Conclusions Both drugs have the same rate of loss of efficacy at 12 months. Therefore, the biosimilar of infliximab is as effective as the long-term reference drug. Comparative and prospective studies are needed to support these results.