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

Rheumatology (Oxford)Published Pooled post-hoc analysis of the BLISS-52, BLISS-76, BLISS-SC and BLISS-Northeast Asia phase III randomised 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 = 0.018
IV 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 use0.66 (0.55–0.78)P < 0.001
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

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