[Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis].

AIM: To evaluate the efficacy and safety of the Russian biosimilar infliximab in patients with ulcerative colitis (UC).

MATERIALS AND

METHODS

This is a retrospective study of stable patients with UC, who are followed up at the department of bowel pathology of Loginov Moscow Clinical Scientific Center and who underwent a non-medical switch from the original infliximab to its Russian biosimilar. The primary outcome is treatment continuation for 16 weeks after the switch. Secondary outcomes include the rate of loss of response, adverse events, and immunogenicity during the first 12 months after the switch.

RESULTS

There was no significant difference in infliximab continuation between the biosimilar, switch and control groups. While the alternation group had the highest rate of loss of response and adverse events.

CONCLUSION

Non-medical switching from the original infliximab to its Russian biosimilar, as well as therapy with a biosimilar under one trade name, demonstrates similar clinical results compared to continuing to take the original molecule for the treatment of UC. The obtained data confirm the safety and efficacy of non-medical switching to infliximab in patients with UC.