Lupus & antiphospholipid syndrome
Spanish multicenter registry of belimumab in systemic lupus erythematosus: Data from daily clinical practice
Authors' conclusion
Our results show that BLM use was associated with improvements in disease activity and serologic markers, along with prednisone dose reductions, and showed an acceptable safety profile.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) (EULAR/ACR 2019, SLICC and/or ACR 1997 criteria) starting belimumab, 44 hospitals in Spain, 2011 to May 202485.7% women
- Participants
- 533 patients
- Exposure
- Period 1 vs Period 2
- Outcome
- Laboratory and clinical data, effectiveness and safety of belimumab
Methodological detailsdescriptive, observational, multicentre, registry, Data collected from clinical history at 44 hospitals throughout Spain
- Descriptive
- Observational
- Multicentre
- Registry
- Data collected from clinical history at 44 hospitals throughout Spain
Main finding
As reported in the abstract
Effectiveness during belimumab treatment · mean follow-up 22.6 months (SD 21.2)
- Significant decreases in prednisone dose, SLEDAI-2K score and anti-dsDNA levels
- Increases in complement C3 and C4
Observational data: associations, not effects.
Further findings
- Treatment start by period — Period 2
- 75%
Kidney biopsy nephritis class (114 patients)
- Class IV
- 44.7%
- Class III
- 21.2%
Treatment start by period
- Period 2: less frequent use of biologic disease-modifying antirheumatic drugs (bDMARD), conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and prednisone; greater drug persistence than period 1
Drug survival by subgroup
- Worse survival in patients treated after bDMARD
- P < 0.001
- No differences in patients treated in monotherapy
- P = 0.06
- Early belimumab (BLM) initiators: drug survival similar to those after at least 1 csDMARD
- Findings consistent in adjusted multivariable models
Safety
Treatment interruption
- Patients who interrupted treatment
- 151 (28.3%)
- Due to lack of efficacy
- 56.7%
- Due to infections
- 12.1%
Original publication
Spanish multicenter registry of belimumab in systemic lupus erythematosus: Data from daily clinical practice. Semin Arthritis Rheum. Published 2 June 2026. doi:10. 1016/ j. semarthrit. 2026. 153004
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