Lupus & antiphospholipid syndrome
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria
Authors' conclusion
In this analysis of five RCTs evaluating belimumab in SLE, belimumab conferred superiority over placebo to yield BICLA response in the overall study population and in subgroups of patients with high global or serological activity at baseline.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE) in five phase III belimumab randomised controlled trials (RCTs)
- Participants
- 3,086 adults5 RCTs
- Comparison
- Belimumab vs placebo
- Belimumabn = 1,869
- Placebon = 1,217reference
- Primary endpoint
- BICLA response (British Isles Lupus Assessment Group (BILAG) improvement; no worsening by BILAG and SLEDAI-2K; no PGA deterioration ≥0.3 (0-3); no treatment failure)
- Follow-up
- Week 52
Methodological detailspooled analysis, 52-week landmark assessments, intravenous (BLISS-52, BLISS-76, BLISS-NEA, EMBRACE) and subcutaneous (BLISS-SC) belimumab
- Pooled analysis
- 52-week landmark assessments
- Intravenous (BLISS-52, BLISS-76, BLISS-NEA, EMBRACE) and subcutaneous (BLISS-SC) belimumab
Primary result
As reported in the abstract
BICLA response
Belimumab vs PlaceboOdds ratio (95% CI)P value
BLISS-52
1.49(1.05–2.12)
P = 0.024BLISS-NEA
1.62(1.12–2.33)
P = 0.010BLISS-SC
1.89(1.39–2.57)
P < 0.001Further findings
BICLA response in subgroups
- Greater with belimumab than placebo irrespective of baseline GC dose (>7.5 or ≤7.5 mg/day prednisone equivalent), with baseline SLEDAI-2K≥10, and with positive anti-dsDNA and/or low C3/C4 at baseline
- Belimumab combined with anti-malarials yielded greater frequency of BICLA response
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria. RMD Open. Published 23 April 2025. doi:10.
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