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Early vs Delayed Belimumab in Lupus

jjcush@gmail.com
Feb 23, 2026 8:00 am

An economic evaluation of early vs delayed use of the Blys inhibitor, belimumab (BEL), in systemic lupus erythematosus (SLE) has shown both cost effectiveness and clinical utility of early BEL initiation in active lupus patients.

While most would advocate for using your best therapy first when treating SLE, would this apply to an expensive biologic?  For many, BEL use is either 2nd or 3rd line choices or reserved for refractory patients.

BEL was FDA approved for use in SLE in 2011 and since then has been approved for use as either an infusion of subcutaneous treatment for SLE, lupus nephritis and pediatric lupus. Its use and utility in hematologic or CNS lupus has not been specifically studied or approved.

A Markov model (simulated, not using real patients) was used to assess the economic and health-related outcomes of early vs delayed BEL in biologic-naive, clinically active SLE patients.  Medical costs were expressed as quality-adjusted life-years (QALYs).

This simulation was based on US payer perspective, based on studies published from 2013 to 2025. Using monthly infusions, patients were characterized as achieving 5 health states: 1)complete response (per SLE Responder Index-4 [SRI-4]), 2) partial response, 3) nonresponse (failure to meet SRI-4 accompanied by flare or treatment-emergent adverse event), 4) no treatment (standard of care), or 5) death.  BEL was initiated either early (≤2 years of disease duration) or delayed (after failure of standard therapy).

The modeled cohort included 1000 adults (91% female) with a mean age of 41 years. Comparisons revealed:

  • Early initiation provided an additional 0.30 (95% UI, −0.42 to 1.39) QALYs at an incremental cost of –$126 337.12 per patient relative to delayed initiation
  • Early BEL had a favorable incremental cost-effectiveness ratio (ICER) of –$421 123.73 per QALY
  • Incremental net monetary benefit (INMB): At a $50 000 per QALY threshold, the mean INMB was $141 337.12. Early initiation was preferred in 81% of simulations 

This cost analysis in active SLE showed that early initiation was associated with improved health outcomes and reduced costs. These data should inform early treatment decisions and reconsideration of reimbursement criteria for BEL use in SLE.

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Disclosures
The author has no conflicts of interest to disclose related to this subject
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