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

Farkas, Klaudia and Rutka, Mariann and Golovics, Petra Anna and Végh, Zsuzsanna and Lovász, Barbara Dorottya and Nyári, Tibor and Gecse, Krisztina Barbara and Bálint, Anita and Nagy, Ferenc and Bor, Renáta and Milassin, Ágnes and Szepes, Zoltán and Palatka, Károly and Lakatos, Péter László and Molnár, Tamás (2015) Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Expert Opinion on Biological Therapy, 15 (9). pp. 1257-1262. ISSN 1471-2598 (Print), 1744-7682 (Online)

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Abstract

Introduction. CT-P13 is the first biosimilar to infliximab that was approved for the same indications as its originator infliximab in June 2014 in Hungary. No data is 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 induction therapy between June 2014 and April 2015 at three Hungarian IBD centers, were prospectively enrolled. Sigmoideoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as a Mayo endoscopic subscore of 0 or 1. Complete mucosal healing was defined as a Mayo endoscopic subscore of 0. Results. Thirty-eight UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication of the therapy was acute, severe flare up and chronic, refractory activity in 16 and 22 patients. Clinical response and remission at week 14 were achieved in 26.3% and 65.8% of the patients. Sigmoideoscopy revealed mucosal healing in 65.8% of the patients, complete mucosal healing was present in 48%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing. Conclusion. This was the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. Our results indicate that mucosal healing is achieved in two thirds of UC patients by the end of the induction treatment with CT-P13.

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