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* = Presenting author

P603 Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients

T. Molnar*, K. Farkas, M. Rutka, A. Bálint, F. Nagy, R. Bor, Á. Milassin, Z. Szepes

University of Szeged, 1st Department of Medicine, Szeged, Hungary

Background

CT-P13 is the first biosimilar to infliximab that has been approved for the same indications than infliximab in June 2014 in Hungary. Studies examining whether CT-P13 is identical to that of reference infliximab will have a high importance. The aim of this study was to examine the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis (UC).

Methods

Patients diagnosed with UC, who were administered CT-P13 from June 2014 at the First Department of Medicine, University of Szeged, were prospectively enrolled. Medical records analyzed included patients' characteristics, previous history of infliximab administration, response to CT-P13, concomitant medications, and adverse drug reaction. Serum activity markers, trough levels and antibody titers have been measured. Sigmoideoscopy was performed at the end of the induction therapy in patients who agreed.

Results

Twelve UC patients were treated with CT-P13 between June and November 2014 at our centre. The indication of the therapy was acute, severe flare up and chronic, refractory activity in 6-6 patients. Male-female ratio was 5:7. Mean age was 34 years (range 20-68). Induction treatments have been done in 9 patients until now. Two patients discontinued the therapy after the second infusion: one, who was previously treated with infliximab and developed high antibody level, because of hypersensitivity reaction and one because of septic complications. Clinical response and remission at week 6 were achieved in 2 and 5 patients. Two patients did not respond to CT-P13 at week 6 (one previously treated with infliximab). Sigmoideoscopy was performed in 9 of the 12 patients. Severe activity was detected in 2 patients; one of them discontinued the therapy after the 2nd infusion and the other did not show response at week 6. Seven patients (four with eMayo score of 1 and three with eMayo score of 0) showed mucosal healing at the end of the induction therapy.

Conclusion

This was the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. CT-P13 induction therapy showed clinical response and remission in 58% of the UC patients. Mucosal healing was revealed in 78% of the patients during or after the induction therapy. Although the number of the enrolled patients is not so high yet, our results indicate that the induction with CT-P13 can result mucosal healing in similar proportion as the originator infliximab.