Long-term efficacy and safety of belimumab in children with systemic lupus erythematosus: a meta-analysis of real-world data
Authors' conclusion
In pediatric SLE, add-on belimumab improves disease control and safety at 6 months and reduces flare risk at 12 months compared with standard immunotherapy.
Study context
- Population
- Children with systemic lupus erythematosus (SLE) (pediatric SLE), real-world data16 cohort studies and trials
- Comparison
- Add-on belimumab vs standard immunotherapy in pediatric SLE
- Outcome
- Long-term efficacy of belimumab: SLEDAI score reduction from baseline
Methodological detailsrandom-effects models, single-arm and double-arm analyses
- Random-effects models
- Single-arm and double-arm analyses
Pooled result
As reported in the abstract
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) reduction from baseline at 6 months (points)
10.16
SLEDAI reduction from baseline at 12 months (points)
17.71
Further pooled results
| Outcome | Estimate | P value |
|---|---|---|
| LN remission, belimumab vs standard immunotherapy · 6 monthsHigher LN remission rates with belimumab | RR for LN remission 1.26 | P = 0.03 |
| Flare, belimumab vs standard immunotherapy · 12 monthsLower flare risk with belimumab | RR for flare 0.44 | P = 0.02 |
SLEDAI score reduction from baseline (single-arm) · 6 and 12 months
- SLEDAI reduction at 6 months (points)
- 10.16
- SLEDAI reduction at 12 months (points)
- 17.71
LLDAS achieved (single-arm) · 6 and 12 months
- LLDAS at 6 months
- 42%
- LLDAS at 12 months
- 79%
Mean GC dose decrease (single-arm) · 6 and 12 months
- GC dose decrease at 6 months (mg/day)
- 19.88
- GC dose decrease at 12 months (mg/day)
- 11.84
12-month flare rate (single-arm)
- Flare rate
- 7%
Lupus nephritis (LN) complete remission (single-arm) · 6 and 12 months
- Complete remission at 6 months
- 88%
- Complete remission at 12 months
- 94%
Safety
| Outcome | RR | P value |
|---|---|---|
| AEs, belimumab vs standard immunotherapy · 6 monthsFewer AEs | 0.37 | P = 0.004 |
Adverse event (AE) rates with belimumab
- AE rate at 6 months
- 12%
- AE rate at 12 months
- 46%
Original publication
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