Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients With Systemic Lupus Erythematosus: A Multicenter, Open‐Label Trial
Authors' conclusion
Exposure following subcutaneous belimumab administration in pediatric patients is consistent with approved usage
Study context
- Population
- Pediatric patients with active systemic lupus erythematosus (SLE) receiving standard therapy
- Comparison
- ≥50 kg vs 30 to <50 kg vs 15 to <30 kg
- Outcome
- Pharmacokinetics: observed belimumab concentration at week 12 and popPK estimates over 52 weeks
- Follow-up
- Week 12
Methodological detailsmulticentre, three-weight-band dosing
- Multicentre
- Three-weight-band dosing
Main finding
As reported in the abstract
Observed belimumab concentration, geometric mean
Further findings
≥4-point reduction from baseline SELENA-SLEDAI (exploratory efficacy) · week 52
- Patients with ≥4-point reduction
- 18 of 22 patients (81.8%)
Simulated two-weight-band dosing (≥40 kg: 200 mg qw; 15 to <40 kg: 200 mg q2w)
- Predicted consistent exposure across weight bands and in line with established exposures in SLE
Safety
Pharmacodynamics and safety
- Profile consistent with known belimumab effects
Original publication
Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients With Systemic Lupus Erythematosus: A Multicenter, Open‐Label Trial. Arthritis Care Res (Hoboken). Published 10 February 2026. doi:10.
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