{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T17:15:04Z","timestamp":1782753304619,"version":"3.54.5"},"reference-count":41,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T00:00:00Z","timestamp":1732147200000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,10,18]]},"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a diverse clinical presentation that involves multiple organ systems and may lead to organ damage and increased risk of mortality. SLE is associated with a high burden of disease that can include loss of productivity and employment and reduced health-related quality of life. The current standard of care for SLE is primarily based on immunosuppression and glucocorticoids and is associated with risk of toxicities and poor tolerability. Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, was recently approved as a new treatment for patients with moderate-to-severe SLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Here, we report the study design of the ongoing, multinational Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) that includes 3-years of follow-up beginning with the first infusion of anifrolumab and 1 year of retrospective baseline data. ASTER aims to enrol 500 adult patients receiving anifrolumab for SLE in Europe and Canada. The key study objective is to describe the real-world effectiveness of anifrolumab in routine clinical practice, including clinician-reported disease activity and patient-reported outcomes collected via mobile application. This mobile application also includes a medication diary, where patients report their prescription and non-prescription medication use for SLE on a weekly basis; these data will lend insights on treatment patterns for the study population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The design of the ASTER study was informed through consultations with patients with SLE who provided important insights to help maximise patient engagement, retention and the collection of key, patient-relevant endpoints. ASTER enrolment began in February 2023 and the study is expected to finish in 2029.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05637112\">NCT05637112<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-086055","type":"journal-article","created":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T02:49:32Z","timestamp":1732243772000},"page":"e086055","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05637112","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05637112","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05637112","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5937-4574","authenticated-orcid":false,"given":"Marta","family":"Mosca","sequence":"first","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathy","family":"Emmas","sequence":"additional","affiliation":[{"name":"Respiratory & Immunology Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassandra","family":"Nekeman-Nan","sequence":"additional","affiliation":[{"name":"CVRM Evidence, BioPharmaceuticals Medical, AstraZeneca, M\u00f6lndal, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heide","family":"Stirnadel-Farrant","sequence":"additional","affiliation":[{"name":"Oncology Outcomes Research, Global Medical Affairs, AstraZeneca, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Chen","sequence":"additional","affiliation":[{"name":"Evidence Delivery, BioPharmaceuticals Medical, AstraZeneca, M\u00f6lndal, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Carty","sequence":"additional","affiliation":[{"name":"Biostatistics, AstraZeneca, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miina","family":"Waratani","sequence":"additional","affiliation":[{"name":"Immunology, AstraZeneca, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Seo","sequence":"additional","affiliation":[{"name":"Patient Centered Science, 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