Lupus & antiphospholipid syndrome
Treat-to-target in SLE: is serology important? Results from an integrated analysis of five randomized clinical trials of belimumab
Authors' conclusion
Normal serology enhances the protection of DORIS and LLDAS against severe and renal SLE flares, possible reflecting deeper states of disease control.
Study context
- Population
- Patients with SLE in five phase III belimumab trials45,254 monthly visits
- Comparison
- DORIS/lupus low disease activity state (LLDAS) with vs without active serology, vs no-DORIS
- Primary endpoint
- Severe flares (BILAG ≥1A/2B) and renal flares (BILAG A/B)
Methodological detailsphase III trials (BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA, EMBRACE), generalized linear models
- Phase III trials (BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA, EMBRACE)
- Generalized linear models
Primary result
As reported in the abstract
Severe flares (BILAG ≥1A/2B)
Each group vs no-DORISOdds ratio (95% CI)
DORIS, anti-dsDNA(-)
0.042(0.005–0.331)
DORIS, normal/high C3/C4
0.216(0.094–0.494)
DORIS, anti-dsDNA(+)
0.511(0.284–0.919)
DORIS, low C3/C4
0.528(0.261–1.067)
Further findings
| Outcome | Values | OR (95% CI) | |
|---|---|---|---|
| Renal flares (BILAG A/B)DORIS with serological activityvs Combined clinical/serological remission∼6-fold higher risk | 5.94 (1.26–28.04) | ||
| 0.050.21520Odds ratio (log scale) |
| Outcome | Values |
|---|---|
| Normal serology among DORIS and LLDAS visits | DORIS visits 29.1% · LLDAS visits 39.5% |
| Damage accrual in sustained DORIS with ≥1 visit showing normal serology | Sustained DORIS, anti-dsDNA(-) 0.8% · Sustained DORIS, normal C3/C4 1.8% |
Damage accrual in sustained DORIS with ≥1 visit showing normal serology
- Damage accrual was lowest in these patients
Original publication
Treat-to-target in SLE: is serology important? Results from an integrated analysis of five randomized clinical trials of belimumab. Rheumatology (Oxford). Published 22 February 2025. doi:10.
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