Lupus & antiphospholipid syndrome
SLE-DAS responder index: a novel outcome measure with high performance for physician and patient outcomes in anifrolumab phase 2–3 trials
Authors' conclusion
The SLE-DAS RI is a robust efficacy end point in SLE trials, associated with sustained disease control and meaningful improvements in patient-reported outcomes.
Study context
- Population
- Placebo-arm patients with SLE from the MUSE, TULIP-1 and TULIP-2 anifrolumab trials3 RCTs' placebo arms
- Participants
- 438 patients
- Comparison
- SLE-DAS Responder Index (RI) responders vs non-responders
- Outcome
- SLE-DAS RI response (reduction in SLE-DAS of ≥1.72 and score ≤7.64)
- Follow-up
- Week 52
Methodological detailsMUSE, TULIP-1, TULIP-2
- MUSE, TULIP-1, TULIP-2
Pooled result
As reported in the abstract
SLE-DAS RI response
Achieved SLE-DAS RI response
34.0%
Further pooled results
Flare risk, responders vs non-responders
- Lower risk of flare in SLE-DAS RI responders
- 41.9%
Identification of moderate-to-severe disease activity (MSDA) by SLE-DAS at screening
- Patients with MSDA identified by SLE-DAS MSDA
- 96.1%
- SLE-DAS MSDA better reflected health-related quality of life (HR-QoL) burden at week 12
Original publication
SLE-DAS responder index: a novel outcome measure with high performance for physician and patient outcomes in anifrolumab phase 2–3 trials. Rheumatology (Oxford). Published 6 April 2026. doi:10.
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