Lupus & antiphospholipid syndrome
Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data
Authors' conclusion
The safety and efficacy of belimumab in older adults were generally consistent with the overall populations, suggesting belimumab is a treatment option for older patients with SLE.
Study context
- Population
- Older adults (≥65 years) with SLE in belimumab trials (BLISS-76, BLISS-52, BLISS-SC, North East Asia study, LBSL02, EMBRACE) and the BASE study63 older adults in pooled safety analysis
- Participants
- 4,170 participants
- Comparison
- Belimumab vs placebo in older adults (≥65 years), compared with the overall SLE populations
Methodological detailspooled analysis of six randomised, placebo-controlled belimumab trials, subgroup analysis by age (≥65 years)
- Pooled analysis of six randomised, placebo-controlled belimumab trials
- Subgroup analysis by age (≥65 years)
Primary result
As reported in the abstract
≥1 SAE in older adults, pooled safety analysis
Further findings
SRI response rates in older adults
- Favoured belimumab vs placebo, consistent with the overall population
Baseline characteristics of older adults vs overall populations
- Lower disease activity but more organ damage
Deaths and adverse events of special interest
- No clinically relevant differences between older adults and the overall populations
Safety
≥1 SAE in older adults, BASE study (n=4003; 156 older adults)
- ≥1 serious adverse event (SAE) in older adults, BASE study (n=4003; 156 older adults): overall population: 220 (11.0%) belimumab vs 222 (11.1%) placebo
Original publication
Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data. Lupus Sci Med. Published 24 March 2023. doi:10.
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