Lupus & antiphospholipid syndrome
Low-dose belimumab reduced risk of flares in patients with systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial
- terminated prematurely
- Terminated prematurely on 10 April 2022 when Renji Hospital became a COVID-19 referral centre during the Shanghai lockdown
Authors' conclusion
Treatment with low-dose belimumab helped reduce the risks of disease flares in Chinese patients with systemic lupus erythematosus at low disease activity.
Study context
- Population
- Patients with SLE at low disease activity (SELENA-SLEDAI ≤6, no A and ≤1 B on BILAG, prednisone ≤20 mg/d at screening)follow-up 31 ± 16.1 weeks
- Participants
- 116 vs 115
- Comparison
- IV low-dose belimumab 120 mg vs placebo
- Belimumabn = 116
- Placebon = 115reference
- Primary endpoint
- Disease flares within 52 weeks
- Follow-up
- 52 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Disease flares
Difference (95% CI)P value
Placebovs Belimumab
11.3%(1.8%–20.9%)
P = 0.012Hazard ratio (95% CI)P value
Belimumabvs PlaceboKaplan-Meier cumulative flare rates
0.38(0.17–0.83)
P = 0.011Further findings
| Outcome | Belimumab | Placebo | P value |
|---|---|---|---|
| Change in SELENA-SLEDAI | 0.62 ± 2.14 | 0.12 ± 2.80 | P = 0.009 |
| Direction | reduced | increased |
GC-sparing effect: Δprednisone from baseline
- Comparable GC-sparing effects, Δprednisone from baseline (belimumab vs placebo, as printed)
- −1.55 ± 10.11 mg/d vs −0.91 ± 7.43 mg/d, P = .075
Safety
Any AEs
- Any AEs comparable (belimumab vs placebo, as printed)
- 61.2% vs 64.3%
Severe AEs
- Severe AEs in the 2 groups, respectively (belimumab, placebo)
- 4 (3.4%) and 6 (5.2%)
Original publication
Low-dose belimumab reduced risk of flares in patients with systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. Published 6 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →