{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T09:32:52Z","timestamp":1792056772973,"version":"4.4.0"},"reference-count":35,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Internal funding of the Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Germany"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Data regarding multiple switches including reverse switching between infliximab and its biosimilars are scarce in the field of inflammatory bowel diseases (IBD). <\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives:<\/jats:title><jats:p> We investigated the clinical effectiveness as primary outcome measure after repeated switches. Secondary endpoints included C-reactive protein (CRP) levels, immunogenicity (trough levels (TL); anti-drug antibodies (ADA), safety and drug persistence. <\/jats:p><\/jats:sec><jats:sec><jats:title>Design:<\/jats:title><jats:p> This study is a prospective, single-centre, observational cohort study. IBD patients receiving originator infliximab were switched to biosimilar SB2 and then reverse switched after 96\u2009weeks and followed up for another 48\u2009weeks. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Clinical disease activity (Harvey\u2013Bradshaw-index (HBI) in Crohn\u2019s disease (CD), partial Mayo score (pMS) in ulcerative colitis (UC)), CRP, TL, ADA, therapy-discontinuations and (serious) adverse events ((S)AE)) were monitored throughout the study. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> Ninety-five patients (60 CD, 38 female) were enrolled. The median HBI was 2 (interquartile range (IQR) 1\u20134) at baseline and 2 (1\u20134) at week 48, resulting in a mean intra-individual change of 0.0 (standard deviation (SD) 1.5). The median pMS was 1 (IQR 0\u20131) at baseline and 0.5 (0\u20131) at week 48 resulting in a mean intra-individual change of 0.0 (SD 0.8). Clinical remission was achieved in 80% at baseline and 82% at week 48. Median CRP 2.0\u2009mg\/l (IQR 1.0\u20134.1) at baseline and 2.4\u2009mg\/l (1.1\u20135.2) at week 48 resulted in a mean change of 1.7 (SD 5.8) and no significant differences in CD ( p\u2009=\u20090.3) and UC ( p\u2009=\u20090.9). Median TL were 7.2\u2009\u00b5g\/ml (IQR 3.8\u201319.3) at baseline and 5.5\u2009\u00b5g\/ml (3.5\u201313.1) at week 48, resulting in a mean change of \u22121.0 (SD 7.4) with no statistical significance (CD p\u2009=\u20090.26, UC p\u2009=\u20090.41). De-novo-ADA were developed by 3.4%. The discontinuation rate was 14.7%. Safety signals were consistent with previous studies. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Reverse switching had no impact on efficacy of infliximab therapy in our cohort of IBD patients. The switch didn\u2019t influence immunogenicity or safety of therapy. <\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848241301887","type":"journal-article","created":{"date-parts":[[2024,11,30]],"date-time":"2024-11-30T12:34:33Z","timestamp":1732970073000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6722-643X","authenticated-orcid":false,"given":"Sarah","family":"Fischer","sequence":"first","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moritz","family":"Donhauser","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Cohnen","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantin","family":"Fietkau","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Vetter","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Gr\u00fcbel-Liehr","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Dietrich","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timo","family":"Rath","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelika","family":"Wilfer","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludmilla","family":"Sologub","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany Deutsches Zentrum Immuntherapie, Erlangen, Germany"},{"name":"Deutsches Zentrum Immuntherapie, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Krebs","sequence":"additional","affiliation":[{"name":"Pharmacy Department, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"D\u00f6rje","sequence":"additional","affiliation":[{"name":"Pharmacy Department, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Nagore","sequence":"additional","affiliation":[{"name":"Progenika Biopharma, Derio, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Meyer","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics, Biometry and Epidemiology, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus F.","family":"Neurath","sequence":"additional","affiliation":[{"name":"First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, 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