Digestive Disease Week 2015
DDW 2015. Tu1348. Biosimilar infliximab in Inflammatory Bowel Diseases: First Interim Results from a Prospective Nationwide Observational Cohort.
Krisztina Gecse(1) , Klaudia Farkas(2) , Barbara D. Lovasz(1) , János Banai(6) , Petra A. Golovics(1) , Tunde Kristof(5) , Laszlo Lakatos(3) , Pal Miheller(4) , Karoly Palatka(8) , Maria Papp(8) , Tamas Szamosi(6) , Zoltan Szepes(2) , Aron Vincze(7) , Tamas Molnar(2) , Peter L. Lakatos(1)
1. 1st Department of Medicine, Semmelweis University, Budapest, Hungary; 2. 1st Department of Medicine, University of Szeged, Szeged, Hungary; 3. Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprem, Hungary; 4. 2nd Deparment of Medicine, Semmelweis University, Budapest, Hungary; 5. 2nd Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary; 6. Department of Gastroenterology, Military Hospital – State Health Centre, Budapest, Hungary; 7. 1st Department of Medicine, University of Pécs, Pecs, Hungary; 8. Department of Gastroenterology, Clinical Center, Institute of Medicine, University of Debrecen, Hungary
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 CD ileocolonic and perianal disease was present in 40.4% and 37.5% of patients, 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.
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.
CARE Faculty Perspective:
The advent of biologics has improved patient outcomes in terms of patient survival as well as drug delivery. With many of Canada’s top selling biologic molecules facing patent expiration before 2020, a greater number of more affordable biosimilars will compete with ‘branded’ biologics. Biosimilars are ‘biologics that are similar to, and enter the market subsequent to, an approved innovator biologic’. These are of interest, yet present challenges. Certain issues and questions surrounding the differences between biosimilars and biologics (eg. Cost, manufacturing, approval processes, etc.), need to be considered as more they are developed and become available.
Canadian Association of Gastroenterology (CAG) recently released a statement regarding biosimilars for IBD.
CAG Summary Statement:
“Biosimilar monoclonal antibodies directed against TNF-α for the treatment of IBD are being developed, yet the complexity of these molecules, together with factors related to their manufacture, have the potential to translate into clinically relevant differences in efficacy, safety and immunogenicity in biosimilar agents. It is important for the Canadian gastroenterology community to gain a full understanding of the important issues in the context of the development and entry into the marketplace of such biologic agents.” For more information, please visit the CAG website.
- CARE Gastroenterology Faculty