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P331 Final results on efficacy and safety of biosimilar infliximab after one-year: results from a prospective nationwide cohort

Gecse K.B.*1, Vegh Z.1, Kurti Z.1, Rutka M.2, Farkas K.2, Golovics P.A.1, Lovasz B.D.1, Gonczi L.1, Banai J.3, Bene L.4, Gasztonyi B.5, Kristof T.6, Lakatos L.7, Miheller P.8, Nagy F.2, Palatka K.9, Papp M.9, Patai A.10, Salamon A.11, Szamosi T.3, Szepes Z.2, Toth G.T.12, Vincze A.13, Molnar T.2, Lakatos P.L.1

1Semmelweis University, First Department of Medicine, Budapest, Hungary 2University of Szeged, First Department of Internal Medicine, Szeged, Hungary 3Military Hospital – State Health Centre, 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 Ferenc Regional Hospital, Department of Internal Medicine, Veszprem, Hungary 8Semmelweis University, Second Departement of Internal Medicine, Budapest, Hungary 9University of Debrecen, Department of Gastroenterology, Debrecen, Hungary 10Markusovszky Hospital, Department of Medicine and Gastroenterology, Szombathely, Hungary 11Tolna County Teaching Hospital, Department of Gastroenterology, Szekszard, Hungary 12Janos Hospital, Department of Gastroenterology, Budapest, Hungary 13University of Pécs, 1st Department of Medicine, Pecs, Hungary

Background

Biosimilar infliximab CT-P13 received positive CHMP recommendation in June 2013 for all indications of the originator product. It has been previously shown that CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases (IBD). We report here final results from a prospective nationwide IBD cohort.

Methods

A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy and safety of CT-P13 infliximab biosimilar in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response and biochemical response was evaluated at week 14, 30 and 54. None of the patients had received infliximab within 12 months prior to initiation of the biosimilar infliximab. Safety data was registered.

Results

353 consecutive IBD (209 CD and 144 UC) patients were included of which 229 patients reached the week 54 endpoint. The age at disease onset was 24/28 years (median, IQR: 19–34 and 22–39) in CD and UC patients, respectively. 31/41% of CD patients had colonic/ileocolonic disease location, 43.5% had complicated disease behaviour, 39% had perianal disease, while 56.2% of UC patients had extensive colitis. 23/19% of patients had received previous anti-TNF therapy in CD and UC, respectively. 60/51% of CD/UC patients received concomitant immunosuppressives at baseline.

49, 53, 48% and 86, 81 and 65% of CD patients reached clinical remission and response by week 14, 30 and 54, respectively. Remission and response rates were 56, 41, 43% and 74, 66 and 50% in UC patients. Previous anti-TNF exposure was associated with decreased clinical efficacy in both CD and UC. Mean CRP decreased significantly both in CD and UC by week 14, which was maintained throughout the 1-year follow-up. 31 (8.8%) patients had infusion reactions, 32 (9%) patients had infections and 1 death occurred.

Conclusion

Final results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure, no new safety signals were detected.