Lupus & antiphospholipid syndrome
Biomarker-stratified efficacy and safety of biologics in systemic lupus erythematosus: a systematic review and meta-analysis
Pooled result · SRI-4 response, biomarker-stratifiedResult — go to the resultRelative risk 1.26 95% CI 1.19–1.33Authors' conclusion
Serologically active disease and high baseline disease activity significantly predict biologic therapy response with zero heterogeneity, while IGS showed inconsistent predictive value.
Study context
- Population
- Adult systemic lupus erythematosus (SLE) patients in randomised controlled trials (RCTs) of biologics (January 2000-October 2025)
- Participants
- 17,374 patients31 RCTs
- Comparison
- Biologics vs control in adult SLE
- Outcome
- SRI-4 response and time-to-flare
Methodological detailsrandom-effects meta-analysis, stratified by interferon gene signature (IGS), serologic activity and high disease activity, false discovery rate correction for multiple comparisons
- Random-effects meta-analysis
- Stratified by IGS, serologic activity and high disease activity
- False discovery rate correction for multiple comparisons
Pooled result
SRI-4 response, biomarker-stratified
Relative risk
1.26
95% CI 1.19–1.33
P < 0.0001
Biologicsvs Control
RR 1.26 (95% CI 1.19–1.33); P < 0.0001
As reported in the abstract
- Serologically active disease: RR
- 1.45 (95% CI 1.28 to 1.63, p<0.0001, I²=0%, NNT=6.5)
- High baseline Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥10: RR
- 1.22 (95% CI 1.13 to 1.32, I²=0%)
- IGS, non-significant trends: RR
- 1.39 (95% CI 0.97 to 2.00, p=0.074, I²=68.5%)
Further pooled results
SRI-4 response, anti-BAFF agents
- Anti-BAFF agents, consistent benefit: RR
- 1.35 (95% CI 1.26 to 1.45)
- Efficacy varied by mechanism
Safety
| Outcome | RR | P value |
|---|---|---|
| Serious adverse eventsLupus flares contribute to SAE counts | 0.90 | P = 0.009 |
| Herpes zoster | 1.19 | P = 0.017 |
Original publication
Biomarker-stratified efficacy and safety of biologics in systemic lupus erythematosus: a systematic review and meta-analysis. Lupus Sci Med. Published 11 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →