Trial reportLupus science & medicine2025
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.
Trial report in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Ability of SLE-DAS and SLEDAI-2K to predict damage accrual in SLE: a real-world 7-year cohort study from Sweden.Rheumatology (Oxford, England) · 2026Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis 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).
methodsWe 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 SLE-DAS, BILAG-2004 and SLEDAI-2K SDA classifications in capturing HR-QoL patient-reported outcomes (PROs).
resultsThe 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.
conclusionThe 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.
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