Lupus & antiphospholipid syndrome
The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis
Authors' conclusion
Patients with SLE treated with BEL plus ST experienced significant improvements in most mucocutaneous and vasculitis manifestations compared with patients receiving PBO plus ST.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE) and SELENA-SLEDAI score ≥6 (BLISS-52, BLISS-76) or ≥8 (BLISS-SC, North East Asia, EMBRACE)
- Participants
- 3,086 adults5 Phase 3 RCTs
- Comparison
- Belimumab plus standard therapy vs placebo plus standard therapy
- Belimumab (BEL)n = 1,869
- Placebo (PBO)n = 1,217reference
- Outcome
- Improvement in SELENA-SLEDAI and BILAG mucocutaneous domains
- Follow-up
- Week 52
Methodological detailsintegrated (Belimumab Summary of Lupus Efficacy (Be-SLE)), Phase 3, placebo-controlled, international, Mucocutaneous and vasculitis manifestations measured at baseline and every 4 weeks for 52 weeks using SELENA-SLEDAI and British Isles Lupus Assessment Group (BILAG)
- Integrated (Be-SLE)
- Phase 3
- Placebo-controlled
- International
- Mucocutaneous and vasculitis manifestations measured at baseline and every 4 weeks for 52 weeks using SELENA-SLEDAI and BILAG
Pooled result
As reported in the abstract
Improvement in mucocutaneous domains
- SELENA-SLEDAI mucocutaneous domain improvement: BEL 59% vs PBO 49%; p < .0001
- BILAG mucocutaneous domain improvement: BEL 54% vs PBO 43%; p < .0001
- Post hoc
Further pooled results
Resolution of SELENA-SLEDAI items (vasculitis, rash, alopecia, mucosal ulcers) · Week 52
- Significant differences favoured BEL for resolution of all SELENA-SLEDAI items
Resolution of BILAG mucocutaneous and vasculitis items · Week 52
- Significant differences favoured BEL for 9 of 20 BILAG items (mild maculopapular eruption, localized active discoid lesions, mild alopecia, small mucosal ulceration, malar erythema, subcutaneous nodules, swollen fingers, major cutaneous vasculitis including ulcers, minor cutaneous vasculitis)
Original publication
The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis. Lupus. Published 5 May 2025. doi:10.
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