P577 Croatian database from 5 centres: efficacy and safety of infliximab biosimilar in treatment of inflammatory bowel disease score patients
N. Turk*1, M. Brinar1, 2, D. Grgic1, A. Kunovic1, R. Prijic1, V. Borzan3, B. Sincic Mijandrusic4, M. Crncevic Urek5, M. Banic5, I. Tadin Hadina6, Z. Puljiz6, M. Simunic6, N. Rustemovic1, 2, S. Cukovic Cavka1, 2, Z. Krznaric1, 2
1University Hospital Centre ‘Zagreb’, Gastroenterology and hepatology, Zagreb, Croatia, 2University of Zagreb, School of medicine, Zagreb, Croatia, 3University Hospital Centre ‘Osijek’, Gastroenterology and hepatology, Osijek, Croatia, 4University Hospital Centre ‘Rijeka’, Gastroenterology and hepatology, Rijeka, Croatia, 5Clinical Hospital ‘Dubrava’, Gastroenterology and hepatology, Zagreb, Croatia, 6University Hospital Centre ‘Split’, Gastroenterology and hepatology, Split, Croatia
Biologics are successful but costly drugs in the treatment of inflammatory bowel disease (IBD) patients. In-vitro studies of biosimilars showed ‘high structural similarity’ with biologics, no significant difference in pharmacokinetics, and preferable price. The main controversy remains in ‘extrapolation’ of indications for IBD patients based on 2 trials with ankylosing spondylitis and rheumatoid arthritis. The purpose of the study is to evaluate efficacy and safety of infliximab biosimilar (InflectraTM, Hospira) in IBD patients in 5 Croatian hospital centres.
The study included 46 patients (33 male and 13 women), mean age of 40.8 yrs. (range 20–69), 25 with ulcerative colitis, 19 with Crohn’s disease, and 2 with undetermined IBD. Medium disease duration before therapy was 61 month (range 1–263). When 7 patients with disease lasting longer than 10 years were excluded, the medium disease duration for the rest of the group was 36 months. Biosimilar was started within 1 year of diagnosis in 10/46 patients (22%). Further, 3 patients were switched to infliximab biosimilar after losing response to adalimumab as first-line therapy and another 3 started adalimumab after losing response to infliximab biosimilar. We used clinical monitoring, laboratory findings and mucosal healing for assessment of biosimilar efficacy.
Medium therapy duration was 8 months (range 3–20), although 7/46 patients did not concluded induction protocol and therefor was not analysed at the end. Moreover, 2 of those 7 patients underwent surgery. In addition, 8 of 39 patients (21%) did not respond to therapy or relapsed within 1 year. The remaining 31/39 patients (79%) were in clinical and laboratory remission, though mucosal healing was reported only in 10/31 (32%) patients in remission. There was no serious adverse reactions reported during the study.
These results are encouraging for majority of patients entering remission but should be interpreted with caution because of the small number of patients and short average therapy duration. One-third of patients entering remission reached mucosal healing, which is in line with earlier findings. No serious adverse events were reported, which improves the safety profile of biosimilar. Larger, randomised, controlled, ‘head to head’ trials with original biologics are needed for complete assessment of biosimilars efficacy and safety.