Lupus & antiphospholipid syndrome
Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab
Authors' conclusion
A history of renal involvement, high baseline proteinuria, hypoalbuminaemia, and C3 consumption were robust determinants of impending renal flares.
Study context
- Population
- Patients with SLE treated for active extra-renal disease in four belimumab trials (BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC)192 with ≥1 renal flare
- Participants
- 3,225 patients
- Comparison
- Baseline predictors of renal flares
- Primary endpoint
- Renal flares
- Follow-up
- Weeks 52-76
Methodological detailsproportional hazards regression
- Proportional hazards regression
Primary result
As reported in the abstract
Baseline predictors of renal flares
- Current/former renal involvement, HR 15.4 (95% CI 8.3-28.2), P < 0.001
- Low serum albumin levels, HR 0.9 (95% CI 0.8-0.9), P < 0.001
- Proteinuria, HR 1.6 (95% CI 1.5-1.7), P < 0.001
- Low C3 levels, HR 2.9 (95% CI 2.1-4.1), P < 0.001
- Anti-dsDNA positivity, HR 2.1 (95% CI 1.4-3.2), P < 0.001; attenuated after adjustments
Further findings
Time to first renal flare
- Median time to first renal flare (days)
- 197
Anti-Sm positivity and renal flares, placebo subgroup
- Placebo subgroup, HR 3.7 (95% CI 2.0-6.9), P < 0.001; not associated in belimumab subgroup
Anti-ribosomal P positivity and renal flares, belimumab subgroup
- Belimumab subgroup only, HR 2.8 (95% CI 1.5-5.0), P = 0.001
Original publication
Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). Published 12 January 2024. doi:10.
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