Efficacy of Infliximab Biosimilar CT-P13 Induction Therapy on Mucosal Healing in Ulcerative Colitis.
BACKGROUND
CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab. No data are available on the effect of infliximab biosimilar on mucosal healing. The aim of this study was to evaluate the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis [UC].


METHODS
UC patients, who received CT-P13 therapy from its local introduction at three Hungarian and one Czech inflammatory bowel disease centres, were prospectively enrolled. Sigmoidoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as Mayo endoscopic subscore 0 or 1. Complete mucosal healing was defined as Mayo endoscopic subscore 0. Trough level of CT-P13 was measured at week 14.


RESULTS
Sixty-three UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication for the therapy was acute, severe flare up and chronic, refractory activity in 24 and 39 patients, respectively. Cumulative clinical response and steroid-free remission at week 14 were achieved in 82.5% and 47.6% of the patients, respectively. Sigmoidoscopy revealed steroid-free mucosal healing in 47.6% of the patients, and complete mucosal healing was present in 27%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing.


CONCLUSIONS
This is, to our knowledge, the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. The results indicate that mucosal healing is achieved in two-thirds of UC patients by the end of the induction treatment with CT-P13.
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Klaudia
K
Farkas
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Mariann
M
Rutka
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
Petra A
PA
Golovics
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
Zsuzsanna
Z
Végh
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
Barbara D
BD
Lovász
Department of Medical Physics and Informatics, University of Szeged, Szeged, Hungary.
Tibor
T
Nyári
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
Krisztina B
KB
Gecse
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.|1 Medical Faculty, Charles University, Prague, Czech Republic.
Martin
M
Kolar
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.|Department of Internal Medicine, Military Hospital, Charles University, Prague, Czech Republic.
Martin
M
Bortlik
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.|Institute of Pharmacology, 1 Medical Faculty, Charles University, Prague, Czech Republic.
Dana
D
Duricova
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.
Nadezda
N
Machkova
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.
Veronika
V
Hruba
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.
Martin
M
Lukas
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.|Department of Paediatrics, Faculty Hospital Motol, 2 Medical Faculty, Charles University, Prague, Czech Republic.
Katarina
K
Mitrova
Institute of Medical Biochemistry and Laboratory Diagnostics, 1 Medical Faculty and General Teaching Hospital, Charles University, Prague, Czech Republic.
Karin
K
Malickova
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Anita
A
Bálint
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Ferenc
F
Nagy
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Renáta
R
Bor
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Ágnes
Á
Milassin
1 Department of Medicine, University of Szeged, Szeged, Hungary.
Zoltán
Z
Szepes
2 Department of Medicine, University of Debrecen, Debrecen, Hungary.
Károly
K
Palatka
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
Péter L
PL
Lakatos
IBD Clinical and Research Centre, Iscare a.s., Prague, Czech Republic.|Institute of Medical Biochemistry and Laboratory Diagnostics, 1 Medical Faculty and General Teaching Hospital, Charles University, Prague, Czech Republic.
Milan
M
Lukas
1 Department of Medicine, University of Szeged, Szeged, Hungary molnar.tamas@med.u-szeged.hu.
Tamás
T
Molnár
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use*; D007413:Intestinal Mucosa / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D000069285:Infliximab
CT-P13; Ulcerative colitis; biosimilar; infliximab; mucosal healing