{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T16:53:15Z","timestamp":1790182395661,"version":"4.1.0"},"reference-count":29,"publisher":"Baishideng Publishing Group Inc.","issue":"48","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["World J Gastroenterol"],"abstract":"<jats:p>BACKGROUND<\/jats:p>\n                  <jats:p>Biologic therapies have transformed the management of inflammatory bowel disease (IBD), yet their high cost poses substantial challenges for healthcare systems. Biosimilars offer a cost-effective alternative, with extensive evidence supporting the safety and efficacy of non-medical switching for infliximab and adalimumab. However, real-world data on ustekinumab biosimilars in IBD remain limited. Given increasing mandates for non-medical switches in Canada, evaluating clinical outcomes is critical to ensure patient safety and treatment sustainability. We hypothesized that switching from originator ustekinumab to a biosimilar would preserve clinical efficacy, safety, and drug persistence in patients with IBD.<\/jats:p>\n                  <jats:p>AIM<\/jats:p>\n                  <jats:p>To evaluate clinical efficacy, treatment persistence, biomarker activity, and adverse events in IBD patients who underwent non-medical biosimilar switching from the ustekinumab originator to a biosimilar.<\/jats:p>\n                  <jats:p>METHODS<\/jats:p>\n                  <jats:p>This was an observational study of consecutive IBD patients who underwent a biosimilar switch. Disease activity, biomarkers, drug sustainability, and adverse events were captured 8 weeks before the switch, at the time of switch (baseline), 12 weeks, and 24 weeks after the switch.<\/jats:p>\n                  <jats:p>RESULTS<\/jats:p>\n                  <jats:p>Of 81 patients were included [85.2% had Crohn\u2019s disease, the median age at inclusion: 42 years (interquartile ranges: 29-61)]. Previous biological exposure was 82.7% and a dose optimization of the originator ustekinumab was performed in 63% before the switch. Drug sustainability at 12 weeks and 24 weeks of switch was 96.3% and 95%, regardless of disease type or phenotype. The discontinuation rate was 4.9%. There was no significant difference in the rates of clinical remission at week 8 before switch, baseline, week 12, and 24 after switch: 87%, 85.9%, 84.3%, and 92.7%, P  = not statistically significant. The biomarker activity was not significantly different for C-reactive protein, hemoglobin, albumin, and fecal calprotectin (P  = not statistically significant). All patients who stopped therapy after the non-medical switch needed a dose optimisation of the originator ustekinumab and had previous biological therapy prior to starting the ustekinumab originator.<\/jats:p>\n                  <jats:p>CONCLUSION<\/jats:p>\n                  <jats:p>Despite prior biologic exposure and frequent dose escalation, switching to ustekinumab biosimilar showed stable efficacy, unchanged biomarkers, and high treatment persistence.<\/jats:p>","DOI":"10.3748\/wjg.v31.i48.114355","type":"journal-article","created":{"date-parts":[[2025,12,26]],"date-time":"2025-12-26T10:29:53Z","timestamp":1766744993000},"source":"Crossref","is-referenced-by-count":6,"title":["Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease"],"prefix":"10.3748","volume":"31","author":[{"given":"Justin","family":"Kritzinger","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivanna","family":"Candel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gynter","family":"Kotrri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huzaifa","family":"Nadeem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waqqas","family":"Afif","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Bitton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Wild","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Talat","family":"Bessissow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter Laszlo","family":"Lakatos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2060","published-online":{"date-parts":[[2025,12,28]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjae091"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab178"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202603"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0142481"},{"key":"B5","unstructured":"Government of Canada.   Canada, Patented Medicine Prices Review Board, Annual Report 2020. Available from: https:\/\/www.canada.ca\/en\/patented-medicine-prices-review\/services\/annual-reports\/annual-report-2020.html"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1093\/jcag\/gwad009"},{"key":"B7","unstructured":"World Health Organization.   Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). [cited 3 August 2025]. Available from: https:\/\/cdn.prod.website-files.com\/666d0695ca3ba7fa496a5068\/66bb07c7504d59e3f6c6df97_who_guideline_01.pdf"},{"key":"B8","unstructured":"European Medicines Agency.   Biosimilar medicines: marketing authorization. 2016. [cited 3 August 2025]. Available from: https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\/biosimilar-medicines-marketing-authorisation"},{"key":"B9","unstructured":"United States Food and Drug Administration.   Biosimilar Product Information, 2022. [cited 3 August 2025]. Available from: https:\/\/www.fda.gov\/drugs\/biosimilars\/review-and-approval#approval%20process"},{"key":"B10","unstructured":"Crohn\u2019s and Colitis Canada.   Biotherapies. [cited 3 August 2025]. Available from: https:\/\/crohnsandcolitis.ca\/About-Crohn-s-Colitis\/IBD-Journey\/Treatment-and-Medications\/Biotherapies?gad_source=1&gclid=CjwKCAiA9bq6BhAKEiwAH6bqoNaI5IfaRIyZt2fLFO6xH6OA6xBqIX0x4HcMbJVXf13AEVU9uceBoCBgQQAvD_BwE#medications-available-in-canada"},{"key":"B11","unstructured":"Australian Government, Department of Health and Aged Care.   Australian Public Assessment Report for WEZLANA [cited 3 August 2025]. 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