Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis – results from multicenter observational cohort

ABSTRACT

Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC.

Methods: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study.

Results: 61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively.

Conclusion: Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.

KEYWORDS:

• Ulcerative colitis
• CT-P13
• mucosal healing
• infliximab biosimilar
• long-term efficacy

Author Contributions

Study conception and design: Tamás Molnár, Klaudia Farkas, Péter L Lakatos, Martin Kolar, Károly Palatka, Pál Mihellerpatients selection and data collection: Anita Bálint, Mariann Rutka, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Szilvia Lovas, Zsuzsanna Végh, Zsuzsanna Kürti, Ágnes Csontos, Renáta Bor, Ágnes Milassin, Anna Fábián, Kata Szántóanalysis and interpretation of data: Tibor Nyári, Anita Bálint, Klaudia Farkasperforming colonoscopy: Klaudia Farkas, Tamás Molnár, Zoltán Szepes, Károly Palatka, Pál Miheller, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukasmanuscript preparation: Anita Bálint, Klaudia Farkas, Tamás Molnársupervision of manuscript preparation: Klaudia Farkas

All authors agree to be accountable for all aspects of the work.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This work was supported by the research grants from the National Research, Development and Innovation Office (Grant ID: 119809 and 125377 and FK-129266), by the UNKP-17-4 New National Excellence Program of the Ministry of Human Capacities and by the EFOP-3.6.2-16-2017-00006 and Foundation of University of Szeged (No. 5S424).