Lupus & antiphospholipid syndrome
SLE Disease Activity Score (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
Authors' 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.
Study context
- Population
- Patients with moderate-to-severe SLE in the placebo arms of the MUSE, TULIP-1 and TULIP-2 trials
- Participants
- 438 pooled placebo arms
- Comparison
- SLE-DAS vs BILAG-2004 and SLEDAI-2K definitions of severe disease activity
- Primary endpoint
- Optimal SLE-DAS cut-off for severe disease activity (SDA) against BILAG-2004 numerical score >11
Methodological detailsderivation and validation, ROC curves against BILAG-2004 numerical score >11 as gold standard, multiple linear regression, Cohen's d effect size
- Derivation and validation
- ROC curves against BILAG-2004 numerical score >11 as gold standard
- Multiple linear regression
- Cohen's d effect size
Primary result
As reported in the abstract
Optimal SLE-DAS cut-off for SDA
| Group | Value | AUC | Sensitivity | Specificity |
|---|---|---|---|---|
| SLE-DAS | >9.90 | 0.847 | 77.8% | 79.6% |
SLE-DAS
Value>9.90
AUC0.847
Sensitivity77.8%
Specificity79.6%
Further findings
Disease activity and health-related quality of life (HR-QoL) by severe disease activity (SDA) classification
- SDA by both SLE-DAS and BILAG-2004 or only by SLE-DAS: similar disease activity; SDA by BILAG-2004 alone: less severe disease and better HR-QoL
- SLE-DAS cut-off associated with worse HR-QoL across multiple patient-reported outcomes (PROs) more consistently than BILAG-2004 or SLEDAI-2K
Original publication
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. Lupus Sci Med. Published 16 May 2025. doi:10. 1136/ lupus-2025-001499
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