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 C...

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Main Authors: Maria I. Timanovskaia, Oleg V. Knyzev, Asfold I. Parfenov
Format: Article
Language:Russian
Published: "Consilium Medicum" Publishing house 2025-01-01
Series:Терапевтический архив
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Online Access:https://ter-arkhiv.ru/0040-3660/article/viewFile/646287/193077
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author Maria I. Timanovskaia
Oleg V. Knyzev
Asfold I. Parfenov
author_facet Maria I. Timanovskaia
Oleg V. Knyzev
Asfold I. Parfenov
author_sort Maria I. Timanovskaia
collection DOAJ
description 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.
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spelling doaj-art-6b192cfc19e04997a422f96b32e448e42025-08-20T02:14:26Zrus"Consilium Medicum" Publishing houseТерапевтический архив0040-36602309-53422025-01-0197214514810.26442/00403660.2025.02.20318478664Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitisMaria I. Timanovskaia0https://orcid.org/0000-0002-7937-2346Oleg V. Knyzev1https://orcid.org/0000-0001-7250-0977Asfold I. Parfenov2https://orcid.org/0000-0002-9782-4860Loginov Moscow Clinical Scientific CenterLoginov Moscow Clinical Scientific CenterLoginov Moscow Clinical Scientific CenterAim. 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.https://ter-arkhiv.ru/0040-3660/article/viewFile/646287/193077ulcerative colitisbiosimilarinfliximab
spellingShingle Maria I. Timanovskaia
Oleg V. Knyzev
Asfold I. Parfenov
Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
Терапевтический архив
ulcerative colitis
biosimilar
infliximab
title Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
title_full Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
title_fullStr Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
title_full_unstemmed Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
title_short Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
title_sort results of non medical switching from original infliximab to its russian biosimilar in patients with ulcerative colitis
topic ulcerative colitis
biosimilar
infliximab
url https://ter-arkhiv.ru/0040-3660/article/viewFile/646287/193077
work_keys_str_mv AT mariaitimanovskaia resultsofnonmedicalswitchingfromoriginalinfliximabtoitsrussianbiosimilarinpatientswithulcerativecolitis
AT olegvknyzev resultsofnonmedicalswitchingfromoriginalinfliximabtoitsrussianbiosimilarinpatientswithulcerativecolitis
AT asfoldiparfenov resultsofnonmedicalswitchingfromoriginalinfliximabtoitsrussianbiosimilarinpatientswithulcerativecolitis