ECCO 2016. Best Abstract 8. Predicting short and medium-term efficacy of the biosimilar infliximab: Trough levels/ADAs or clinical/biochemical markers play a more important role?

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P.A. Golovics1, Z. Vegh1, M. Rutka2, K. Gecse1, A. Balint2, K. Farkas2, J. Banai3, L. Bene4, B. Gasztonyi5, T. Kristof6, L. Lakatos7, P. Miheller8, K.Palatka9, A. Patai10, A. Salamon11, T. Szamosi3, Z. Szepes12, G.T. Toth13, A. Vincze14, E. Biro15, B. Lovasz1, Z. Kurti1, F. Nagy12, T. Molnar2, P. Lakatos1

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

Medicine and Gastroenterology, Szombathely, Hungary, 11Tolna County Teaching Hospital, 1st Department of Gastroenterology, Szeksz\ard, Hungary, 12University of Szeged, First Department of Internal Medicine, Szeged, Hungary, 13Janos Hospital, Department of Gastroenterology, Budapest, Hungary, 14University of Pecs, 1st Department of Medicine, Pecs, Hungary, 15Semmelweis University, Department of Laboratory Medicine, Budapest, Hungary

Results: Included in the present cohort were 291 consecutive IBD patients (184 Crohn’s disease [CD] patients and 107 ulcerative colitis [UC] patients). Of CD and UC patients, 24.5/14% and 60/52% received previous anti-TNF and concomitant immunosuppressives at baseline. Mean TLs were 20.1, 14.7 and 5.1 μg/ml at weeks 2, 6 and 14 (n = 124, 86 and 158). Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% in IBD patients at weeks 0, 14, and 30 (n total = 229, 192, and 143). Early TLs at week 2 predicted short-term (week-14 response/remission, AUCTL week 2 = 0.715/0.721, p = 0.05/0.005,) but not medium-term (week 30 or 54) clinical efficacy. TLs measured at week 6/14 did not predict either short- or medium-term clinical outcome. In addition, early ADA status by week 14 (p = 0.04–0.05, odds ratio [OR]: 2.1–2.6 for week 14 and 30), early clinical response (p < 0.001, OR: 7.7–42.8 for week 30/54), and normal C-reactive protein (CRP) at week 14 (p = 0.005–0.0001, OR: 3.2–7.8 for week 14 and 30) and previous anti-TNF exposure (p = 0.03–0.0001, OR: 2.22–6.25, for week 14, 30, and 54) were associated with short- and medium-term clinical outcomes (response and remission).

Conclusion: Early TLs were only associated with short-term clinical outcomes. ADA development by week 14, early clinical response, normal CRP at week 14 and previous anti-TNF exposure predicted medium-term clinical outcomes.