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

Lupus Sci MedPublished Post hoc analysis of pooled placebo-arm data from the MUSE, TULIP-1 and TULIP-2 randomised trials

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
GroupValueAUCSensitivitySpecificity
SLE-DAS>9.900.84777.8%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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