Lupus & antiphospholipid syndrome
Belimumab efficacy in mucocutaneous manifestations of systemic lupus erythematosus: a large post hoc analysis of five phase III clinical trials
Authors' conclusion
Belimumab is superior to placebo in inducing improvement and in preventing flares in the mucocutaneous domain of SLE, especially in patients with high disease activity and in serologically active patients.
Study context
- Population
- Patients with SLE in five phase III trials (BLISS-52, BLISS-76, BLISS-NEA, EMBRACE, BLISS-SC)
- Participants
- 3,086 patients5 phase III trials
- Comparison
- Belimumab vs placebo on top of standard therapy
- Outcome
- Improvement in mcBILAG and mcSLEDAI-2K; prevention of mcBILAG flares
- Follow-up
- Week 52
Methodological detailsintegrative analysis, logistic and Cox regression adjusted for trial variance
- Integrative analysis
- Logistic and Cox regression adjusted for trial variance
Pooled result
As reported in the abstract
Mucocutaneous improvement
Belimumab vs PlaceboOdds ratio (95% CI)P value
mcBILAG improvement
1.29(1.07–1.57)
P = 0.008mcSLEDAI-2K improvement
1.37(1.16–1.62)
P < 0.001Further pooled results
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Sustained improvement (≥2 visits, maintained through week 52)Belimumabvs PlacebomcBILAG | 1.23 (1.07–1.41) | P = 0.003 | |
| Sustained improvement (≥2 visits, maintained through week 52)Belimumabvs PlacebomcSLEDAI-2K | 1.24 (1.17–1.31) | P < 0.001 | |
| mcBILAG flares, positive anti-dsDNA (subgroup) | 0.70 (0.50–0.98) | P = 0.035 | |
| mcBILAG flares, baseline SLEDAI-2K ≥10 (subgroup)Near-significant separation | 0.71 (0.51–1.00) | P = 0.050 | |
| 0.512Hazard ratio (log scale) |
Improvement in subgroups by baseline SLEDAI-2K and anti-dsDNA
- Associations held for SLEDAI-2K ≥10 and positive anti-dsDNA at baseline, but not their counter groups
Mucocutaneous BILAG (mcBILAG) flares, counter groups (negative anti-dsDNA; SLEDAI-2K <10)
- No difference seen
Original publication
Belimumab efficacy in mucocutaneous manifestations of systemic lupus erythematosus: a large post hoc analysis of five phase III clinical trials. Rheumatology (Oxford). Published 14 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →