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* = Presenting author

P314 Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort

K. Gecse*1, K. Farkas2, B. Lovasz1, J. Banai3, L. Bene4, B. Gasztonyi5, P.A. Golovics1, T. Kristof6, L. Lakatos7, P. Miheller8, F. Nagy9, K. Palatka10, M. Papp10, A. Patai11, A. Salamon12, T. Szamosi3, Z. Szepes9, G.T. Toth13, A. Vincze14, T. Molnar2, P. Lakatos1

1Semmelweis University, 1st Department of Medicine, Budapest, Hungary, 2University of Szeged, 1st Department of Medicine, Szeged, Hungary, 3Military Hospital, State Health Centre, Department of Gastroenterology, Budapest, Hungary, 4Peterfy Hospital, 1st Department of Medicine, Budapest, Hungary, 5Zala County Hospital, 2nd Department of Medicine, Zalaegerszeg, Hungary, 6B-A-Z County and University Teaching Hospital, 2nd Department of Medicine, Miskolc, Hungary, 7Csolnoky F. Province Hospital, Department of Medicine, Veszprem, Hungary, 8Semmelweis University, 2nd Department of Medicine, Budapest, Hungary, 9University of Szeged, First Department of Internal Medicine, Szeged, Hungary, 10University of Debrecen, Institute of Medicine, Department of Gastroenterology, Debrecen, Hungary, 11Markusovszky Hospital, 1st Department of Medicine and Gastroenterology, Szombathely, Hungary, 12Tolna County Teaching Hospital, 1st Department of Gastroenterology, Szekszard, Hungary, 13Janos Hospital, Department of Gastroenterology, Budapest, Hungary, 14University of Pecs, 1st Department of Medicine, Pecs, Hungary

Background

Biosimilars are biologic medicines that enter the market subsequent to an original reference product whose patent has expired. Biosimilar infliximab received EMA approval in June 2013 and entered the Hungarian market in May 2014. Few data is yet available on the safety and efficacy of biosimilar infliximab in extrapolated indications, such as inflammatory bowel diseases.

Methods

A prospective, nationwide, multicentre, observational cohort was designed to examine the safety and efficacy of CT-P13 infliximab biosimilar in induction and maintenance of remission in Crohn's disease (CD, 108 weeks follow-up) and ulcerative colitis (UC, 54 weeks follow-up). Demographic data were prospectively collected at inclusion and a harmonized, tight monitoring strategy was applied in terms of clinical scores (CDAI, PDAI, MAYO/pMAYO each visit), biochemical markers (incl. CRP, at least every 3 months) and endoscopic/imaging (at least every 12 months) as requested by the National Health Fund. Sera is collected for drug through and antibody measurement at 0, 12, 24 and 52 weeks. Safety data was meticulously registered during follow-up

Results

90 consecutive IBD patients were included in the present cohort (57 CD patients (27 males) and 33 UC patients (16 males)) Age at disease onset was 26.0 (SD:10.9) years in CD and 30.5 (SD:14.1) years in UC. In CDileocolonic and perianal disease was present in 40.4% and 37.5%, respectively. 55.2% of UC patients had extensive colitis. 21.4% of CD patients had previous surgery. In CD and UC, 60.4%/50% and 55.2%/74.2% of patients received concomitant immunosuppressives and steroids, while 30.4% of CD and 16.1% of UC patients received previous anti-TNFs. At induction, mean CDAI was 289(SD:107), while MAYO/pMAYO scores were 8.8(SD 3.1) and 6.4(SD 2.6) in UC. There was a significant decrease in CDAI after 2 and 6 weeks of treatment compared to baseline p<0.001, ANOVA-Scheffe). In addition there was a numeric decrease in the mean CRP level(from 23.5mg/L to W2:11.3mg/L and W6:15.3mg/L). There was a significant decrease also in the mean pMAYO score(from 6.4 to (n=16) W2:3.7 and W6:3.6) with a numeric decrease in CRP level during induction therapy in UC . 4 allergic reactions occurred, all in patients who had received previous anti-TNF medication.

Conclusion

This is the first prospective nationwide cohort examining the safety and efficacy of the biosimilar infliximab in IBD. A significant decrease of disease activity (CDAI and pMAYO) was observed coupled with a decrease in CRP levels during induction with the infliximab biosimilar. A complete analysis of the induction data will be available at the time of congress.