{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T06:44:25Z","timestamp":1777877065999,"version":"3.51.4"},"reference-count":49,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100011218","name":"Sandoz","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011218","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Musculoskeletal"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Biosimilar biologic disease-modifying antirheumatic drugs (bDMARDs) are increasingly used in clinical practice; however, real-world evidence regarding safety outcomes is currently limited. Denmark has rapidly implemented biosimilars through nationwide mandatory switches, introducing infliximab biosimilars CT-P13 in 2015 and GP1111 in 2019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To investigate the incidence of serious safety outcomes among Danish real-world arthritis patients (including biosimilar-to-biosimilar switchers) during the first year of infliximab biosimilar GP1111 treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis initiating GP1111 during April 1, 2019\u2013April 1, 2022 were identified in the nationwide DANBIO registry. Comorbidities at treatment start (=baseline) and safety outcomes (major adverse cardiac events (MACE), venous thromboembolic events (VTEs), deaths, severe allergic reactions, and serious infections) during 1-year follow-up were captured through linkage to nationwide registries by using diagnoses registered from hospital contacts. Each safety outcome was assessed separately in the overall GP1111 cohort and in five sub-cohorts (based on bDMARD treatment history). We calculated 1-year crude and age- and sex-adjusted incidence rates (IRs) of each safety outcome. Furthermore, baseline factors associated with risks were assessed in the overall cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>In total, 2132 patients initiating GP1111 treatment were included, whereof 1534 (72%) were infliximab-biosimilar-to-biosimilar switchers. For the overall cohort, adjusted IRs for MACE, VTEs, death, and allergic reactions were very low (\u2a7d1.0\/100\u2009person-years). For serious infections, the adjusted IR was 3.2 (95% confidence interval (CI) 2.5\u20134.2) for the overall cohort, varying across sub-cohorts (IRs 2.1\u20135.6). Prior serious infection increased risk of serious infection (hazard ratio\u2009=\u20092.06 (95% CI 1.19\u20133.57), whereas other baseline factors, including biologic treatment history did not. Due to few events, similar analyses were not presented for other safety outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This study demonstrated that 1\u2009year of treatment with biosimilar infliximab GP1111 was safe regardless of treatment history. The rate of serious infections was comparable to originator tumor necrosis factor inhibitors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1759720x251393114","type":"journal-article","created":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T08:25:34Z","timestamp":1766478334000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety outcomes in 2132 Danish patients with inflammatory arthritis treated with biosimilar infliximab (GP1111) in routine care"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6331-7927","authenticated-orcid":false,"given":"Hafsah","family":"Nabi","sequence":"first","affiliation":[{"name":"Copenhagen Center for Arthritis Research and DANBIO, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Valdemar Hansens Vej 17, Glostrup 2600, Denmark"},{"name":"Department of Clinical Medicine, 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Andreas","family":"Just","sequence":"additional","affiliation":[{"name":"Section of Rheumatology, Department of Medicine, Svendborg Hospital\u2014Odense University Hospital, Svendborg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens Kristian","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Section of Rheumatology, Department of Medicine, Svendborg Hospital\u2014Odense University Hospital, Svendborg, Denmark"},{"name":"Department of Rheumatology, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kamilla","family":"Danebod","sequence":"additional","affiliation":[{"name":"Center for Rheumatology and Spine Diseases, Department of Rheumatology, Rigshospitalet, Glostrup, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heidi Lausten","family":"Munk","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Odense University Hospital, Odense, 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