{"title":"[Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis].","authors":"M I Timanovskaia, O V Knyzev, A I Parfenov","doi":"10.26442/00403660.2025.02.203184","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the efficacy and safety of the Russian biosimilar infliximab in patients with ulcerative colitis (UC).</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":22209,"journal":{"name":"Terapevticheskii Arkhiv","volume":"97 2","pages":"145-148"},"PeriodicalIF":0.3000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Terapevticheskii Arkhiv","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.26442/00403660.2025.02.203184","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Терапевтический архив
The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal.
Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases.
The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists.
The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal.
The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory.
The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations.
By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE).
The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.
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