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* = Presenting author

DOP028 Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort

K. Gecse*1, Z. Vegh1, Z. Kurti1, M. Rutka2, K. Farkas2, J. Banai3, L. Bene4, B. Gasztonyi5, P. A. Golovics1, T. Kristof6, L. Lakatos7, P. Miheller8, F. Nagy9, K. Palatka10, M. Papp11, L. Lakner12, A. Patai13, A. Salamon14, T. Szamosi3, Z. Szepes9, B. Szalay15, G. T. Toth16, A. Vincze17, T. Molnar2, P. Lakatos1

1Semmelweis University, First Department of Medicine, Budapest, Hungary, 2University of Szeged, First Department of Medicine, Szeged, Hungary, 3Military Hospital, State Health Centre, Department of Gastroenterology, Budapest, Hungary, 4Peterfy Hospital, First Department of Medicine, Budapest, Hungary, 5Zala County Hospital, Second Department of Medicine, Zalaegerszeg, Hungary, 6B-A-Z County and University Teaching Hospital, Second Department of Medicine, Miskolc, Hungary, 7Csolnoky F. Province Hospital, Department of Medicine, Veszprem, Hungary, 8Semmelweis University, Second 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, 11University of Debrecen, Institute of Internal Medicine, Department of Gastroenterology, Debrecen, Hungary, 12Markusovszky Hospital, Department of Medicine and Gastroenterology, Szombathely, Hungary, 13Markusovszky Hospital, First Department of Medicine and Gastroenterology, Szombathely, Iceland, 14Tolna County Teaching Hospital, First Department of Gastroenterology, Szekszard, Hungary, 15Semmelweis University, Department of Laboratory Medicine, Budapest, Hungary, 16Janos Hospital, Department of Gastroenterology, Budapest, Hungary, 17University of Pécs, First Department of Medicine, Pécs, 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). However, prospective, long-term data on the efficacy and safety of the biosimilar infliximab in IBD are lacking.

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 harmonised monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at week 14, 30, and 54. None of the patients had received infliximab within 12 months before initiation of the biosimilar infliximab. Safety data were registered.

Results

Included in the present cohort were 291 consecutive IBD (184 CD and 107 UC) patients, of which 100 patients reached the week 54 endpoint. The age at disease onset was 23/28 years (median, IQR 19–34 and 22–39) in CD and UC patients, respectively. Further, 32%/49% of CD patients had colonic/ileocolonic disease location; 41% had complicated disease behaviour; 35% had perianal disease; and 23% had gone through previous surgery.

Of UC patients, 8%/59% had proctitis/left-sided colitis/extensive colitis, and 25%/14% of patients had received previous anti-TNF therapy in CD and UC, respectively. Moreover, 60%/52% of CD/UC patients received concomitant immunosuppressives at baseline, and 55%, 57%, and 47% of CD patients reached clinical remission by week 14, 30, and 54, respectively. Clinical response was 83%, 77%, and 58%, respectively, and 59%, 46%, and 53% of UC patients reached clinical remission by week 14, 30, and 54. Clinical response was 78%, 69% and 64%, respectively. Previous anti-TNF exposure was associated with lower response and remission rates in both CD (p < 0.001/0.01, p = 0.014/0.05, and p = 0.002/0.04) and UC (p = NS/0.06, p = 0.1/0.1, and p = 0.048/0.03) at weeks 14, 30, and 54. Mean CRP decreased from baseline week 14, 30, and 54 (CRP level decreased from 20.5 to W14: 8, W30: 8.7 and W54: 12.1mg/L in CD and from 29.5 to W14: 8.5, W30: 13 and W54: 12.3 mg/L in UC). 21 (6.6%) patients had infusion reactions, 23 (7.9%) patients had infections and 1 death occurred.

Conclusion

This prospective nationwide cohort shows that CT-P13 is effective and safe in maintaining remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure.