Publicação
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
| dc.contributor.author | Diogo Jesus | |
| dc.contributor.author | Matos, Ana | |
| dc.contributor.author | Henriques, Carla | |
| dc.contributor.author | Andrea Doria | |
| dc.contributor.author | Luis Sousa Ines | |
| dc.date.accessioned | 2026-04-14T10:41:19Z | |
| dc.date.available | 2026-04-14T10:41:19Z | |
| dc.date.issued | 2025-01 | en_US |
| dc.date.updated | 2026-04-13T17:48:28Z | |
| dc.description.abstract | Objectives This study aimed to derive and validate a cutoff 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). Methods 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 >11 as gold standard. Multiple linear regression analysis and Cohen’s d effect size were applied to evaluate the effectiveness of SLEDAS, BILAG-2004 and SLEDAI-2K SDA classifications in capturing HR-QoL patient-reported outcomes (PROs). Results The optimal SLE-DAS cut-off for SDA was >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. Conclusion 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. | por |
| dc.description.version | N/A | |
| dc.identifier.doi | 10.1136/lupus-2025-001499 | en_US |
| dc.identifier.slug | cv-prod-4624491 | |
| dc.identifier.uri | http://hdl.handle.net/10400.19/9772 | |
| dc.language.iso | N/A | por |
| dc.subject | lupus | |
| dc.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 | en_US |
| dc.type | research article | en_US |
| dspace.entity.type | Publication | |
| oaire.citation.title | Lupus Science & Medicine | en_US |
| person.familyName | Matos | |
| person.familyName | Henriques | |
| person.givenName | Ana | |
| person.givenName | Carla | |
| person.identifier.ciencia-id | 961C-1FBD-5555 | |
| person.identifier.ciencia-id | F91C-B000-9ED8 | |
| person.identifier.orcid | 0000-0001-6408-5857 | |
| person.identifier.orcid | 0000-0002-2142-2849 | |
| person.identifier.scopus-author-id | 8506082100 | |
| person.identifier.scopus-author-id | 8955187400 | |
| rcaap.cv.cienciaid | F91C-B000-9ED8 | Carla Manuela Ribeiro Henriques | |
| rcaap.rights | openAccess | en_US |
| relation.isAuthorOfPublication | 69997266-781a-4811-ab7b-5282d69b00e6 | |
| relation.isAuthorOfPublication | 9138da60-0a34-4302-b547-864d612c30b8 | |
| relation.isAuthorOfPublication.latestForDiscovery | 69997266-781a-4811-ab7b-5282d69b00e6 |