P327 Biosimilar infliximab in real-life Crohn’s disease’s anti-TNFalfa naïve patients: a comparative observational cohort study (SIMRECRO study)
L. Carvalho Lourenço*, V. Anapaz, A. M. Oliveira, J. Branco, M. Cardoso, C. Graça Rodrigues, L. Santos, D. Horta, A. Martins, J. Reis
Hospital Prof Dr Fernando Fonseca, Serviço de Gastrenterologia, Amadora, Portugal
Biosimilars are biologic drugs that entered the market subsequent to an original reference product whose patent has expired. Biosimilar infliximab CT-P13 received European Medicines Authority (EMA) approval and entered Portuguese market after September 2013. Few data are yet available on the safety and efficacy of biosimilar infliximab in disease management, such as that for Crohn’s disease (CD).
A retrospective and prospective monocentric observational cohort study was designed to examine the safety and efficacy of infliximab biosimilar (CT-P13) in induction and maintenance of remission in CD (during 24 weeks of follow-up) and compare those results with previous experienced results with reference infliximab. Demographic data were prospectively collected at inclusion (clinical scores using the Harvey–Bradshaw Index [HBI] and biochemical markers CRP and faecal calprotectin), and data from controls were retrospectively reviewed based on a prospectively collected data base.
In total, 60 consecutive CD patients were included in the present cohort (19 patients were treated with CT-P13 [group 1] and 41 with reference infliximab [group 2]). Age at disease onset was 29.4(SD 10.9) years in group 1 and 31.3 (SD 14.1) years in group 2. Ileocolonic and perianal disease was present in 31.6% and 41.2%, respectively, in group 1 and 39.0 % and 46.3% in group 2. Further, 31.6% of group 1 patients and 28.8% of group 2 had previous surgery. In group 1 and group 2, 63.2%/51.2% of patients received concomitant immunomodulators. At induction, mean HBI was 12.6 in group 1 and 11.4 in group 2. There was a significant decrease in HBI after 6 and 24 weeks of treatment compared with baseline in both groups (p < 0.01, ANOVA-Scheffe). There was also a decrease in the mean CRP level in group 1 and 2 (from 18.9/15.8 mg/L to W6:11.9/8.5 mg/L and W24:6.3/4.7 mg/L, p < 0.01). There were no reported allergic reactions with CP-13 during follow-up time; 1 patient developed latent tuberculosis and 1 patient died of postoperative septic complications. During the same follow-up time, in patients treated with reference infliximab, there were 3 allergic reactions and 2 patients died of septic complications (not related to CD). Globally, and although CT-P13 showed less early infusion-related allergic reactions in our population, results showed no statistically significant difference when compared with the original reference product.
A significant decrease of disease activity was observed coupled with a decrease in CRP levels during induction with both regimens. Early results obtained with biosimilar CT-P13 were not inferior to those obtained before. A longer follow-up time will be necessary to assess safety and efficacy in maintenance of remission, especially when compared with the original reference product.