Z Gastroenterol 2015; 53 - A11
DOI: 10.1055/s-0035-1551853

Biosimilar Infliximab in inflammatory bowel diseases: First interim results from a prospective nationwide observational cohort

K Gecse 1, K Farkas 2, B Lovász 1, J Banai 3, L Bene 4, B Gasztonyi 5, P Golovics 1, T Kristóf 6, L Lakatos 7, P Miheller 8, F Nagy 2, K Palatka 9, M Papp 9, VÁ Patai 10, Á Salamon 11, T Szamosi 3, Z Szepes 2, T Tóth 12, Á Vincze 13, T Molnár 2, P Lakatos 1
  • 11st Department of Internal Medicine, Semmelweis University, Budapest, Hungary
  • 21st Department of Internal Medicine, University of Szeged, Szeged, Hungary
  • 3Military Hospital – State Health Centre, Budapest, Hungary
  • 41st Department of Medicine, Peterfy Hospital, Budapest, Hungary
  • 52nd Department of Medicine, Zala County Hospital, Zalaegerszeg, Hungary
  • 62nd Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary
  • 7Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprém, Hungary
  • 82nd Department of Internal Medicine, Semmelweis University, Budapest, Hungary
  • 9Institute of Medicine, Department of Gastroenterology, University of Debrecen, Debrecen, Hungary
  • 10Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary
  • 11Department of Gastroenterology, Tolna County Teaching Hospital, Szekszárd, Hungary
  • 12Department of Gastroenterology, Janos Hospital, Budapest, Hungary
  • 131st Department of Medicine, University of Pécs, Pécs, Hungary

Introduction: Biosimilars are biologic medicines that enter the market subsequent to an original reference product whose patent has expired. Biosimilar infliximab 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) and ulcerative colitis (UC). Demographic data were collected at inclusion. A harmonized, tight monitoring strategy was applied in terms of clinical outcome (CDAI, PDAI, MAYO/pMAYO at each visit), biochemical markers (at least every 3 months) and endoscopy/imaging (at least every 12 months) as requested by the National Health Fund. Sera were collected for drug through and antibody measurement at 0, 12, 24 and 52 weeks. Safety data was registered during the follow-up. Results: 90 consecutive IBD patients (57 CD and 33 UC) were included in the cohort. Age at disease onset was 26.0years in CD and 30.5years in UC. In CD ileocolonic 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. 30.4% of CD and 16.1% of UC patients received previous anti-TNF treatment. At induction, the 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). There was a significant decrease also in the mean pMAYO score (from 6.4 to 3.7 and 3.6 at week 2 and 6) induction therapy in UC. Clinical improvement was coupled with a decreasing trend regarding biochemical markers. 4 allergic reactions occurred, all in patients who had received previous anti-TNF medication. Conclusions: 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.