Lupus & antiphospholipid syndrome

Administration of belimumab prior to standard immunosuppression in patients with early active lupus hinders accrual of new EULAR/American College of Rheumatology (ACR) criteria within the first 12 months of treatment

Lupus Sci MedPublished Multicentre observational study

Authors' conclusion

Early administration of BEL in active SLE significantly delays disease progression and promotes GC withdrawal.

Study context

Population
Patients with early active SLE (diagnosed ≤12 months from enrolment, ≤2 clinical EULAR/ACR 2019 criteria, no major organ involvement, active serology)
Participants
69 patients
Exposure
Early belimumab vs standard immunosuppression, both on glucocorticoid (GC) and hydroxychloroquine (HCQ) as standard of care (SoC)
Outcome
Accrual of new EULAR/ACR criteria (marker of disease progression)
Follow-up
12 months
Methodological detailsKaplan-Meier survival analysis and log-rank tests, Cox regression
  • Kaplan-Meier survival analysis and log-rank tests
  • Cox regression

Main finding

As reported in the abstract

New EULAR/ACR criteria accrual, events per 100 patient-years

P = 0.035

Observational data: associations, not effects.

Further findings

Criteria-free survival, mean time-to-event · 12 months · criteria-free survival longer with BEL

log-rank p=0.04

OutcomeORP value
Criteria-free survival, mean time-to-event · 12 monthsLag time to criteria accrualCox regression, p=0.027
GC discontinuation · 12 monthsBEL vs HCQ and GC alone · vs patients on HCQ and GC alone6.67P = 0.0014

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Administration of belimumab prior to standard immunosuppression in patients with early active lupus hinders accrual of new EULAR/ACR criteria within the first 12 months of treatment. Lupus Sci Med. Published 22 October 2025. doi:10.1136/lupus-2025-001662

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