{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T21:20:00Z","timestamp":1758057600765,"version":"3.44.0"},"reference-count":30,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T00:00:00Z","timestamp":1747353600000},"content-version":"unspecified","delay-in-days":135,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Lupus Sci Med"],"accepted":{"date-parts":[[2025,4,25]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>This study aimed to derive and validate a cut-off for severe disease activity (SDA) using the SLE Disease Activity Score (SLE-DAS) and compare its accuracy and impact on health-related quality of life (HR-QoL) with the British Isles Lupus Assessment Group 2004 (BILAG-2004) and SLE Disease Activity Index 2000 (SLEDAI-2K).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We performed a post hoc analysis of pooled placebo arm data from the MUSE (A Phase II, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus), TULIP-1 and TULIP-2 (Treatment of Uncontrolled Lupus via the Interferon Pathway) trials, including 438 patients with moderate-to-severe SLE. SLE-DAS was scored retrospectively, and a cut-off for SDA was derived using receiver operating characteristic (ROC) curves against the BILAG-2004 numerical score &gt;11 as gold standard. Multiple linear regression analysis and Cohen\u2019s d effect size were applied to evaluate the effectiveness of SLE-DAS, BILAG-2004 and SLEDAI-2K SDA classifications in capturing HR-QoL patient-reported outcomes (PROs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The optimal SLE-DAS cut-off for SDA was &gt;9.90 (area under the ROC curve=0.847, sensitivity=77.8%, specificity=79.6%). Patients classified as SDA by both SLE-DAS and BILAG-2004 or only by SLE-DAS exhibited similar disease activity, while those classified by BILAG-2004 alone had less severe disease and better HR-QoL. The SLE-DAS cut-off was associated with worse HR-QoL across multiple PROs more consistently than BILAG-2004 or SLEDAI-2K.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The SLE-DAS cut-off for SDA provides an accurate definition of SDA in SLE, with good discriminative power and consistent associations with worse HR-QoL. This SLE-DAS definition enhances disease activity classification and offers a practical tool for guiding treatment decisions in clinical practice, as well as selecting patients with SDA for inclusion in clinical trials.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/lupus-2025-001499","type":"journal-article","created":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T09:50:18Z","timestamp":1747389018000},"page":"e001499","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["SLE-DAS enables an accurate definition of severe lupus disease activity: derivation and validation in a post hoc study of anifrolumab phase II and III studies"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct01438489","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02446912","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02446899","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3136-0722","authenticated-orcid":false,"given":"Diogo","family":"Jesus","sequence":"first","affiliation":[{"name":"Rheumatology Department, Unidade Local de Saude da Regiao de Leiria, Leiria, Portugal"},{"name":"Faculdade de Ci\u00eancias da Sa\u00fade, Universidade da Beira Interior, Covilha, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6408-5857","authenticated-orcid":false,"given":"Ana","family":"Matos","sequence":"additional","affiliation":[{"name":"Polytechnic Institute of Viseu, Viseu, Portugal"},{"name":"Research Centre in Digital Services (CISeD), Viseu, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2142-2849","authenticated-orcid":false,"given":"Carla","family":"Henriques","sequence":"additional","affiliation":[{"name":"Polytechnic Institute of Viseu, Viseu, Portugal"},{"name":"Centre for Mathematics, University of Coimbra, Coimbra, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0548-4983","authenticated-orcid":false,"given":"Andrea","family":"Doria","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, University of Padua, Padua, Italy"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3172-3570","authenticated-orcid":false,"given":"Luis Sousa","family":"Ines","sequence":"additional","affiliation":[{"name":"Faculdade de Ci\u00eancias da Sa\u00fade, Universidade da Beira Interior, Covilha, Portugal"},{"name":"Rheumatology Department, Unidade Local de Sa\u00fade de Coimbra, Coimbra, Portugal"}]}],"member":"239","published-online":{"date-parts":[[2025,5,16]]},"reference":[{"key":"2025091514033912000_12.1.e001499.1","doi-asserted-by":"crossref","first-page":"103428","DOI":"10.1016\/j.autrev.2023.103428","article-title":"What is the best instrument to measure disease activity in SLE? - SLE-DAS vs Easy BILAG","volume":"23","author":"In\u00eas","year":"2024","journal-title":"Autoimmun Rev"},{"key":"2025091514033912000_12.1.e001499.2","first-page":"607","article-title":"Performance of SLEDAI-2K to detect a clinically meaningful change in SLE disease activity: a 36-month prospective cohort study of 334 patients","volume":"28","author":"Jesus","year":"2019","journal-title":"Lupus (Los 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