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Sequential therapy with belimumab and rituximab in SLE: Results from the phase III BLISS-BELIEVE trial
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The phase III BLISS-BELIEVE trial (NCT03312907) evaluated the safety and efficacy of sequential therapy with BEL/RTX in patients with active SLE, following corticosteroid and immunosuppressant withdrawal. Results were published in Annals of the Rheumatic Diseases by Aranow et al.1 A total of 263 patients were included in the mITT population. |
| Key learnings |
| BEL/RTX, in comparison with BEL/PBO, showed no significant differences in the primary endpoint of disease activity control at Week 52 (19.4% vs 16.7%, respectively; p = 0.5342) or in the major secondary endpoints, such as clinical remission at Week 64 and disease control at Week 104. |
| The mean duration of longest disease control response through 52 weeks was significantly longer in BEL/RTX- vs BEL/PBO-treated patients (adjusted treatment difference: 47.0 days; 95% CI: 8.0, 86.0 days; p = 0.0188). |
| BEL/RTX significantly reduced anti-dsDNA antibody levels compared with BEL/PBO from baseline to Week 52 (p = 0.0495) and Week 64 (p = 0.0230), with more patients transitioning from antibody-positive at baseline to antibody-negative at Week 52 (p = 0.0186). Additionally, CD19+ B cells and B-cell subsets were significantly reduced with BEL/RTX vs BEL/PBO at Week 52 (p < 0.0001). |
| The incidence of serious infections and infestations was higher with BEL/RTX (5.6%) vs RTX/PBO (2.8%). The safety profile of the combination was in line with the known AEs of belimumab and rituximab. |
| While the primary and major secondary endpoints were not met, the sequential therapy with BEL/RTX led to significant improvements in disease activity markers compared with BEL/PBO. Further investigation of the combination is warranted. |
Abbreviations: AE, adverse event; BEL, belimumab; mITT, modified intention-to-treat; PBO, placebo; RTX, rituximab; SLE, systemic lupus erythematosus.
- Aranow C, Allaart CF, Amoura Z, et al. 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. 2024;83(11):1502-1512.
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