{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T22:58:33Z","timestamp":1781650713279,"version":"3.54.5"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T00:00:00Z","timestamp":1776729600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T00:00:00Z","timestamp":1780531200000},"content-version":"vor","delay-in-days":44,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arthritis Res Ther"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Over the past decade, rheumatoid arthritis (RA) management in the UK has evolved with increased use of biologic and targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The introduction of biosimilars, including AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , has expanded treatment options and improved access for patients. This study aims to (1) describe the clinical characteristics and serious adverse events (SAEs) in RA patients treated with AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , and (2) similarly, describe the incidence of these outcomes from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) anti-tumor necrosis factor (anti-TNF) comparison cohort.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The BSRBR-RA is a national registry for patients with RA receiving biologic treatments, including anti-TNF inhibitors (e.g., adalimumab) and non-anti-TNF biologics, designed to evaluate the long-term safety and effectiveness of these agents in clinical practice. SAE analyses derived from an interim pharmacovigilance report on a subset of all AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      and anti-TNF patients in the BSRBR-RA based on the Manchester Template Report. Eligible participants were \u2265\u200916 years of age with RA who registered in the registry within 6 months of initiating AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . Descriptive statistics were calculated for all variables of interest.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From 01\/01\/2019 to 31\/03\/2022, 288 RA patients initiating AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      were enrolled. Follow-up ended 30\/11\/2023. The mean (SD) age was 59.7 (12.0) years; 86 (28.0%) were male; and mean (SD) disease duration at initiation was 9.9 (9.8) years. Two-thirds of AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      patients were biologically na\u00efve and 9.8% were using steroids at initiation. The crude incidence rate of SAEs in the AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      cohort was 9.6 per 1,000 patient-years (95% CI: 3.1\u201322.4), including 37.5 serious infections per 1,000 patient-years (95% CI: 95% CI: 23.2\u201357.3). For context, the anti-TNF comparator cohort had a crude SAE rate of 13.3 per 1,000 patient-years (95% CI: 10.6\u201316.5) and a serious infection rate of 49.1 per 1,000 patient-years (95% CI: 43.8\u201354.8).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The crude incidence rates of SAEs and serious infections among AMGEVITA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      users were within the range observed for the anti-TNF comparator cohort. These findings provide supportive real-world safety data, although differences in baseline characteristics and the absence of adjusted analyses should be considered when interpreting results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13075-026-03807-9","type":"journal-article","created":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T17:34:45Z","timestamp":1776792885000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Characteristics and safety outcomes of rheumatoid arthritis patients treated with AMGEVITA\u00ae in the United Kingdom using data from a national register"],"prefix":"10.1186","volume":"28","author":[{"given":"Argentina E.","family":"Servin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lillie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ran","family":"Jin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura C.","family":"Coates","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Brunori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Latha","family":"Krishnamoorthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Accortt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Humby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,21]]},"reference":[{"issue":"9","key":"3807_CR1","doi-asserted-by":"publisher","first-page":"1580","DOI":"10.1136\/ard.2010.138461","volume":"69","author":"D Aletaha","year":"2010","unstructured":"Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology\/European League Against Rheumatism collaborative initiative. 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Informed consent was obtained from patients (or their authorized representative) at enrolment to the BSRBR-RA. The consent to be involved in the BSRBR-RA observational study covers the current AMGEVITA study analyses.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AES, ML, RJ, MB, LK, NA \u2013 All authors are full-time employees of Amgen Inc. and hold stock and\/or stock options as part of their employment compensation. This manuscript reports on data related to an Amgen product. The authors declare no additional financial or personal conflicts of interest. FH \u2013 The author declares the following potential conflicts of interest. The author has served as a consultant for Roche, AbbVie, Genentech, UCB, and Novartis. Honoraria have been received from Roche, UCB, and Novartis. The author has participated in speakers\u2019 bureaus for UCB and Novartis. The author reports no corporate appointments, stock ownership, royalties, grants\/research support, or other relevant financial or personal relationships that could influence the work reported in this manuscript. LCC \u2013 The author has received grants\/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Oruka, Pfizer, Sitryx, Takeda and UCB; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"126"}}