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OP003 Predicting short and medium-term efficacy of the biosimilar infliximab: trough levels/do anti-drug antibodys or clinical/biochemical markers play a more important role?

P. A. Golovics*1, 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

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 Debrecen, Institute of Medicine, Department of Gastroenterology, Debrecen, Hungary, 10Markusovszky Hospital, First Department of Medicine and Gastroenterology, Szombathely, Iceland, 11Tolna County Teaching Hospital, First Department of Gastroenterology, Szekszard, Hungary, 12University of Szeged, First Department of Internal Medicine, Szeged, Hungary, 13Janos Hospital, Department of Gastroenterology, Budapest, Hungary, 14University of Pécs, First Department of Medicine, Pécs, Hungary, 15Semmelweis University, Department of Laboratory Medicine, Budapest, Hungary

Background

Biosimilar infliximab CT-P13 received EMA approval in June 2013 for all indications of the originator product. Its use has been mandatory in all anti-tumour necrosis factor (TNF) naïve inflammatory bowel disease (IBD) patients in Hungary since May 2014. In the present study, we aimed to evaluate prospectively the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab in 2 IBD centres in Hungary.

Methods

Demographic data were collected, and a harmonised monitoring strategy was applied. Clinical and biochemical activity were evaluated at weeks 14, 30, and 54. Trough level (TL) and anti-drug antibody (ADA) concentration were measured by ELISA (LT-005, Theradiag, France) at baseline, at week 2,6,14, 30, and 54 weeks right before anti-TNF administration.

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.