Lupus & antiphospholipid syndrome

Spanish multicenter registry of belimumab in systemic lupus erythematosus: Data from daily clinical practice

Semin Arthritis RheumPublished Retrospective cohort study

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

Composed by AI from the published abstract and checked against it. How Briefs are made →

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