Lupus & antiphospholipid syndrome
Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study
Primary result · Disease controlResult — go to the resultOdds ratio 1.27 95% CI 0.60–2.71Authors' conclusion
BEL/RTX showed no superiority over BEL/PBO for most endpoints analysed; however, it led to significant improvements in disease activity markers compared with BEL/PBO.
Study context
- Population
- Patients with active systemic lupus erythematosus (SLE) initiating SC belimumab (BEL)modified ITT population
- Participants
- 263 patients
- Comparison
- SC BEL plus one cycle of IV rituximab (RTX) vs SC BEL plus IV placebo; BEL plus standard therapy as reference arm
- BEL/RTXn = 144
- BEL/PBOn = 72reference
- Primary endpoint
- Disease control (SLEDAI-2K ≤2; without immunosuppressants; prednisone equivalent ≤5 mg/day), BEL/RTX vs BEL/PBO
- Follow-up
- Week 52
Methodological detailsphase 3, double-blind, placebo-controlled
- Phase 3
- Double-blind
- Placebo-controlled
Primary result
Disease control
Odds ratio
1.27
95% CI 0.60–2.71
P = 0.5342
Events by treatment group
BEL/RTXvs BEL/PBO
OR 1.27 (95% CI 0.60–2.71); P = 0.5342
As reported in the abstract
Secondary outcomes
Major secondary endpoints: clinical remission (week 64) and disease control (week 104)
- Differences between BEL/RTX and BEL/PBO not statistically significant
Anti-dsDNA antibodies and B cells/B-cell subsets
- Anti-dsDNA antibodies and most assessed B cells/B-cell subsets lower with BEL/RTX vs BEL/PBO
Mean disease control duration through 52 weeks
- Significantly greater with BEL/RTX vs BEL/PBO
Original publication
Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study. Ann Rheum Dis. Published 21 October 2024. doi:10.
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