{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T05:51:55Z","timestamp":1781589115461,"version":"3.54.5"},"reference-count":51,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Incidents of infections associated with biosimilar biological disease\u2010modifying antirheumatic drugs (bDMARDs) have been communicated to the Saudi Food and Drug Authority (SFDA). This study aimed to evaluate the infection risk related to biosimilar bDMARDs and assess the applicability of the prevalent new\u2010user design within a Saudi cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using the Saudi Real\u2010World Evidence Network (SRWEN), patients aged \u2265\u200914\u2009years who initiated or switched to biosimilar versus reference bDMARDs between 2016 and 2025 were identified. A prevalent new\u2010user design that accounted for prior exposure to reference bDMARDs was implemented. Time\u2010conditional propensity score (TCPS) matching (1:1 and 1:3) balanced baseline covariates. The study outcome was the risk of any infection, identified via ICD\u201010 codes in the main analysis, in addition to laboratory results and antimicrobial prescriptions in the sensitivity analyses. Hazard ratios (HRs) were estimated using Cox proportional hazards models with robust sandwich estimators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 5721 patients contributing 59\u2009856 treatment episodes, 2178 were biosimilar initiators and 2909 were switchers (from the reference product). Adalimumab accounted for 69.5% of use. Over a median 1.6\u2010year follow\u2010up, infection incidence rates were comparable between reference and biosimilar groups (456.7 vs. 422.0 per 1000 person\u2010years). Adjusted HRs showed no significant difference in infection risk (HR 0.89; 95% CI 0.57\u20131.39,\n                      <jats:italic>p<\/jats:italic>\n                      \u2010value: 0.61), with consistent findings across sensitivity and disease\u2010matched analyses where the adjusted HR was 0.87 (95% CI 0.51\u20131.50,\n                      <jats:italic>p<\/jats:italic>\n                      \u2010value: 0.62).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this real\u2010world Saudi cohort, no statistically significant difference in infection risk was observed between biosimilar and reference bDMARD. Larger studies and further evaluation of the prevalent new\u2010user design are needed to enhance post\u2010marketing biosimilar surveillance in the region.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70388","type":"journal-article","created":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T07:20:51Z","timestamp":1779866451000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Prevalent\u2010New User Design for Biosimilar Safety Using Saudi Real\u2010World Data"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6246-0841","authenticated-orcid":false,"given":"Ohoud","family":"Almadani","sequence":"first","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Almaha","family":"Alfakhri","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Asiri","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulrahman","family":"Alturaiki","sequence":"additional","affiliation":[{"name":"Ministry of National Guard\u2014Health Affairs  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulrahman","family":"Alrashid","sequence":"additional","affiliation":[{"name":"Ministry of National Guard\u2014Health Affairs  Riyadh Saudi Arabia"},{"name":"King Abdullah International Medical Research Centre KAIMRC  Riyadh Saudi Arabia"},{"name":"King Saud Bin Abdulaziz University for Health Sciences KSAU\u2010HS  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Turki","family":"Althunian","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"},{"name":"College of Medicine Alfaisal University  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,27]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2022-223365"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2024-004546"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.2147\/OARRR.S523778"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1520063"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202603"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2019-000900"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.156983.1"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01256-5"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0304851"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2022.2113252"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.medidd.2020.100075"},{"key":"e_1_2_12_13_1","volume-title":"Saudi Food and Drug Authority. 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