Lupus & antiphospholipid syndrome
Pragmatic targets for moderate/severe systemic lupus erythematosus (SLE) and their implications for clinical care and trial design: sustained Definition of Remission in SLE (DORIS) or Lupus Low Disease Activity State (LLDAS) for at least 6 months is sufficient while their attainment for at least 24 months ensures high specificity for damage-free progression
Authors' conclusion
In moderate-to-severe SLE, sustained DORIS/LLDAS for at least 6 months is sufficient, while attainment for at least 24 months ensures higher specificity for damage-free progression, thus facilitating treat-to-target strategies and clinical trials.
Study context
- Population
- Patients with active moderate-to-severe SLE (PGA ≥1.5 and/or SLEDAI-2K ≥6, requiring therapy intensification); median follow-up 5 yearshistorical cohort
- Participants
- 348 patients
- Exposure
- Sustained DORIS or LLDAS for ≥6 months vs not attained
- Outcome
- Damage accrual and severe flares by sustained DORIS/LLDAS attainment
Methodological detailshistorical cohort, shared frailty survival, generalised linear models, K-means clustering
- Historical cohort
- Shared frailty survival
- Generalised linear models
- K-means clustering
Main finding
As reported in the abstract
Sustained DORIS and LLDAS for ≥6 months: attainment, damage accrual and severe flares
Hazard ratio (95% CI)
DORISvs Not attaineddamage accrual
0.58(0.36–0.93)
LLDASvs Not attaineddamage accrual
0.61(0.43–0.86)
DORISvs Not attainedsevere flares
0.14(0.08–0.27)
LLDASvs Not attainedsevere flares
0.19(0.13–0.27)
Observational data: associations, not effects.
Further findings
| Outcome | HR (CI) | |
|---|---|---|
| LLDAS without DORIS: damage and flaresLLDAS without DORISvs Not attainedDamage | 0.65 (0.43–0.98) | |
| LLDAS without DORIS: damage and flaresLLDAS without DORISvs Not attainedFlares | 0.49 (0.36–0.67) | |
| 0.20.5125Hazard ratio (log scale) |
Optimal target duration (DORIS ≥50% and LLDAS ≥60% of time, or ≥24 and ≥36 months) for damage-free outcome
- Feasibility
- 20.2-41.7%
- Specificity
- 73.3-86.1%
- Hospitalisation, RR
- 0.70
- Mortality, RR
- 0.06-0.13
Predominant arthritis and mucocutaneous disease vs major organ involvement
- Reduced DORIS/LLDAS with predominant arthritis and mucocutaneous disease vs major organ involvement
Safety
Serious adverse events with optimal-duration targets
- Serious adverse events, RR
- 0.56-0.71
Original publication
Pragmatic targets for moderate/severe SLE and their implications for clinical care and trial design: sustained DORIS or LLDAS for at least 6 months is sufficient while their attainment for at least 24 months ensures high specificity for damage-free progression. Ann Rheum Dis. Published 12 March 2024. doi:10.
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