Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis

Klaudia Farkas, Mariann Rutka, Petra A. Golovics, Zsuzsanna Végh, Barbara D. Lovász, T. Nyári, Krisztina B. Gecse, Martin Kolar, Martin Bortlik, Dana Duricova, Nadezda Machkova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Anita Bálint, Ferenc Nagy, Renáta Bor, Ágnes Milassin, Zoltán SzepesK. Palatka, Péter L. Lakatos, Milan Lukas, Tamás Molnár

Research output: Article

55 Citations (Scopus)

Abstract

Introduction: 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]. Patients and 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 steroidfree 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. Conclusion: 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 twothirds of UC patients by the end of the induction treatment with CT-P13.

Original languageEnglish
Pages (from-to)1273-1278
Number of pages6
JournalJournal of Crohn's and Colitis
Volume10
Issue number11
DOIs
Publication statusPublished - jan. 1 2016

ASJC Scopus subject areas

  • Gastroenterology

Fingerprint Dive into the research topics of 'Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis'. Together they form a unique fingerprint.

  • Cite this

    Farkas, K., Rutka, M., Golovics, P. A., Végh, Z., Lovász, B. D., Nyári, T., Gecse, K. B., Kolar, M., Bortlik, M., Duricova, D., Machkova, N., Hruba, V., Lukas, M., Mitrova, K., Malickova, K., Bálint, A., Nagy, F., Bor, R., Milassin, Á., ... Molnár, T. (2016). Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Journal of Crohn's and Colitis, 10(11), 1273-1278. https://doi.org/10.1093/ecco-jcc/jjw085