PhD Scientific Days 2017

Oral Presentations: Clinical Sciences

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

Előadó neve

Dr. Gönczi, Lóránt

Előadó munkahelye

Semmelweis Egetem, I. sz. Belgyógyászati Klinika

Előadó telefonszáma

30/820-8250

Előadó e-mail címe

lorantgonczi@gmail.com

Az előadás címe

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

Szerző(k) neve és munkahelye

L. Gonczi1, Z. Kurti1, K.B. Gecse1, Z. Vegh1, M. Rutka2, K. Farkas2, P.A. Golovics1, B.D. Lovasz1, J. Banai3, L. Bene4, B. Gasztonyi5, T. Kristof6, L. Lakatos7, P. Miheller8, F. Nagy2, K. Palatka9, M.Papp9, A. Patai10, A. Salamon11, T.Szamosi3, Z. Szepes2, G.T. Toth12, A. Vincze13, T. Molnar2, P.L.Lakatos1
1 Semmelweis University, First Department of Medicine, Budapest, Hungary,
2 University of Szeged, First Department of Internal Medicine, Szeged, Hungary,
3 Military Hospital – StateHealth Centre, 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 ofMedicine, Miskolc, Hungary,
7 Csolnoky Ferenc Regional Hospital, Department of Internal Medicine, Veszprem, Hungary,
8 Semmelweis University, Second Departement of Internal Medicine, Budapest, Hungary,
9 University of Debrecen, Department of Gastroenterology, Debrecen, Hungary,
10 Markusovszky Hospital, Department of Medicine and Gastroenterology, Szombathely, Hungary,
11 Tolna County Teaching Hospital, Department of Gastroenterology,Szekszard, Hungary,
12 Janos Hospital, Department of Gastroenterology, Budapest, Hungary,
13 University of Pécs, 1st Department of Medicine, Pecs, Hungary

Szekció

Oral Presentations: Clinical Sciences

Data of the presenter

Doctoral School: Clinical Medicine
Program: 2/15
Supervisor: Péter László Lakatos
lakatos.peter_laszlo@med.semmelweis-univ.hu

Text of the abstract

Background and Aim
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 12months prior to initiation of the biosimilar infliximab.

Results
353 consecutive IBD (209CD and 144UC) patients were included of which 229 patients
reached the week 54 endpoint. The age at disease onset was 24/28years (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.

Conclusions
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.

Kind

Szabad

Előadás fájl jóváhagyás

nem rendelkezett róla

Előadó

1103

Authors (legacy)

L. Gonczi1, Z. Kurti1, K.B. Gecse1, Z. Vegh1, M. Rutka2, K. Farkas2, P.A. Golovics1, B.D. Lovasz1, J. Banai3, L. Bene4, B. Gasztonyi5, T. Kristof6, L. Lakatos7, P. Miheller8, F. Nagy2, K. Palatka9, M.Papp9, A. Patai10, A. Salamon11, T.Szamosi3, Z. Szepes2, G.T. Toth12, A. Vincze13, T. Molnar2, P.L.Lakatos1
1 Semmelweis University, First Department of Medicine, Budapest, Hungary,
2 University of Szeged, First Department of Internal Medicine, Szeged, Hungary,
3 Military Hospital – StateHealth Centre, 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 ofMedicine, Miskolc, Hungary,
7 Csolnoky Ferenc Regional Hospital, Department of Internal Medicine, Veszprem, Hungary,
8 Semmelweis University, Second Departement of Internal Medicine, Budapest, Hungary,
9 University of Debrecen, Department of Gastroenterology, Debrecen, Hungary,
10 Markusovszky Hospital, Department of Medicine and Gastroenterology, Szombathely, Hungary,
11 Tolna County Teaching Hospital, Department of Gastroenterology,Szekszard, Hungary,
12 Janos Hospital, Department of Gastroenterology, Budapest, Hungary,
13 University of Pécs, 1st Department of Medicine, Pecs, Hungary