Lupus & antiphospholipid syndrome
Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials
Authors' conclusion
The protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when belimumab was administered along with AMA.
Study context
- Population
- Patients with active SLE yet no severe ongoing nephritis, treated for extra-renal diseasepooled BLISS trials
- Participants
- 3,225 patients
- Comparison
- Belimumab vs placebo, plus standard therapy; antimalarial use vs no use
- Primary endpoint
- Renal flare development
- Follow-up
- Study (52-76 weeks)
Methodological detailspooled data, placebo-controlled, Cox regression analysis
- Pooled data
- Placebo-controlled
- Cox regression analysis
Primary result
As reported in the abstract
Renal flare · 52-76 weeks
Hazard ratio (95% CI)P value
IV belimumab 10 mg/kgvs Placebo
0.62(0.41–0.92)
P = 0.018IV belimumab 1 mg/kgvs Placebo
0.42(0.22–0.79)
P = 0.007- Patients developing a renal flare
- 192
- Median time to renal flare (days)
- 197
Further findings
Renal flare, antimalarial agents (AMA) use
| HR (95% CI) | P value | ||
|---|---|---|---|
| AMA use | 0.66 (0.55–0.78) | P < 0.001 | |
| 0.512Hazard ratio (log scale) |
- Renal flare, AMA use — Protection enhanced when belimumab and AMA co-administered; lowest flare rate with IV belimumab 1 mg/kg plus AMA (cases per 1000 person-years)
- 18.5
Original publication
Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). Published 25 May 2023. doi:10. 1093/ rheumatology/ kead253
Composed by AI from the published abstract and checked against it. How Briefs are made →