Lupus & antiphospholipid syndrome
Impact of belimumab on the utility of serological markers for assessing systemic lupus erythematosus activity
Authors' conclusion
In SLE patients treated with BEL, the clinical utility of serological markers appears dissociated from disease activity. While C3 and C4 levels were not clearly related to disease activity or flares, low C3 levels showed a borderline association with moderate-to-severe flares, and anti-dsDNA positivity remained associated with increased flare risk
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) treated with belimumab (BEL), BELILES-GEAS registrymedian drug exposure 13.2 months
- Participants
- 371 patients
- Outcome
- Dynamics of C3, C4 and anti-dsDNA levels and their association with clinical activity and flares
Methodological detailslongitudinal, BELILES-GEAS registry
- Longitudinal
- BELILES-GEAS registry
Main finding
As reported in the abstract
Observational data: associations, not effects.
Further findings
Low C3 and moderate-to-severe flares (stratified by flare severity)
| OR (95% CI) | ||
|---|---|---|
| Low C3Borderline association | 1.82 (0.99–3.31) | |
| 0.20.5125Odds ratio (log scale) |
| Outcome | P value |
|---|---|
| Flare-discriminative performance (AUC-ROC)SLEDAI-2K vs cSLEDAI · AUC-ROCs 0.779 vs 0.781; similar | P = 0.88 |
Seropositivity at baseline
- Seropositive patients
- 70.1%
Changes over time
- SLEDAI-2K and cSLEDAI scores and prednisone doses decreased significantly over time
- Serum C3 and C4 levels, anti-dsDNA positivity and immunosuppressant use remained stable
Low C3 and moderate-to-severe flares (stratified by flare severity)
- No significant associations for C4 or for mild flares
C3 or C4 and cSLEDAI
- No association between serum C3 or C4 and cSLEDAI
Original publication
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