Lupus & antiphospholipid syndrome
Belimumab concentrations and immunogenicity in relation to drug effectiveness and safety in SLE within a Swedish real-world setting
Authors' conclusion
Belimumab yielded no immunogenicity. Belimumab levels were modestly associated with clinical activity but not with serological activity or adverse events.
Study context
- Population
- SLE patients treated with intravenous belimumab, Swedish real-world setting
- Participants
- 100 patients
- Outcome
- ADA occurrence and associations between belimumab concentrations and clinical response, serological outcomes and adverse events
Methodological detailsreal-world setting, longitudinal analysis using generalized estimating equations, cross-sectional Spearman's rank correlation analyses, Samples at baseline and months 3, 6, 12 and 24; belimumab by quantitative sandwich ELISA, anti-drug antibody (ADA) by acid-dissociation radioimmunoassay
- Real-world setting
- Longitudinal analysis using generalized estimating equations
- Cross-sectional Spearman's rank correlation analyses
- Samples at baseline and months 3, 6, 12 and 24; belimumab by quantitative sandwich ELISA, ADA by acid-dissociation radioimmunoassay
Main finding
As reported in the abstract
Belimumab concentrations, immunogenicity and association with clinical activity
- Belimumab concentration, median (IQR 20.9-43.5 μg/ml); stable over time at group level
- 25.8 μg/ml
- Pre-existing ADA (patients)
- 2
- Patients developing ADA during follow-up
- 0
- Correlation with SLEDAI-2K at month 6, ρ (P = 0.003)
- −0.37
- Correlation with PGA at month 6, ρ (P = 0.005)
- −0.41
- Longitudinal association with SLEDAI-2K, β (SE: 0.05; P = 0.031)
- −0.10
- Longitudinal association with SLE activity measure (SLAM-R), β (SE: 0.13; P = 0.014)
- −0.32
Observational data: associations, not effects.
Further findings
Belimumab levels and serological markers (C3, C4, anti-dsDNA)
- Moderate correlations at month 6, but no associations in longitudinal analysis
Safety
- No relationship between belimumab levels and adverse events
Original publication
Belimumab concentrations and immunogenicity in relation to drug effectiveness and safety in SLE within a Swedish real-world setting. Rheumatology (Oxford). Published 3 March 2025. doi:10.
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