From the Guidelines
Belimumab (Benlysta) is effective for treating pediatric lupus, demonstrating significant improvement in disease activity in children with systemic lupus erythematosus (SLE). The Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy, also known as the PLUTO trial, showed that belimumab had a 53% response rate compared to 44% with placebo, with improvements in disease flares, steroid reduction, and quality of life measures 1.
Key Findings
- The medication works by targeting B-lymphocyte stimulator (BLyS), reducing abnormal B cell activity that contributes to lupus pathogenesis.
- Common side effects include nausea, diarrhea, fever, and infusion reactions.
- Patients should be monitored for infections, depression, and hypersensitivity reactions.
Treatment Considerations
- Belimumab should be considered particularly for pediatric lupus patients with high disease activity despite standard therapies, especially those with significant renal involvement or requiring high-dose corticosteroids.
- The recommended dosage is 10 mg/kg intravenously every 2 weeks for the first 3 doses, then every 4 weeks thereafter, or alternatively, 200 mg subcutaneously once weekly for patients ≥12 years weighing ≥40 kg.
Disease Management
- Lupus nephritis (LN) in children is more common at presentation and more severe with increased damage accrual, and the diagnosis, management, and monitoring are similar to that of adults 1.
- A coordinated transition program to adult specialists is essential to ensure adherence to therapy and optimization of long-term outcomes 1.
From the FDA Drug Label
The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving BENLYSTA plus standard therapy compared with placebo plus standard therapy. Pediatric patients receiving BENLYSTA plus standard therapy also had a lower risk of experiencing a severe flare compared with placebo plus standard therapy [see Clinical Studies (14. 3)].
The conclusion of the Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy is that belimumab is effective in treating pediatric lupus, as it increases the proportion of patients achieving an SRI-4 response and reduces the risk of severe flares when added to standard therapy 2.
- Key findings include:
- Higher SRI-4 response rates in patients receiving belimumab plus standard therapy
- Lower risk of severe flares in patients receiving belimumab plus standard therapy
- Main benefit of belimumab in pediatric lupus patients is the improvement in disease activity and reduction in severe flares.
From the Research
Efficacy of Belimumab in Treating Pediatric Lupus
- The Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO) demonstrated similar efficacy and safety of belimumab in pediatric patients with systemic lupus erythematosus (SLE) compared to adult SLE patients 3.
- A study published in 2023 found that evidence of effectiveness of belimumab in pediatric SLE and lupus nephritis is limited, despite FDA approval 4.
- Real-world use and outcomes of belimumab in childhood-onset lupus showed that daily oral glucocorticoid doses were significantly lower 6 and 12 months after belimumab initiation than baseline 5.
- A review of available data on belimumab in childhood SLE found that it can inhibit disease activity, reduce corticosteroid and immunosuppressant doses, and delay kidney damage 6.
- An across-study comparison of belimumab in pediatric and adult patients with SLE found consistent efficacy and safety across both populations 7.
Key Findings
- Belimumab has been shown to be effective in reducing disease activity and improving outcomes in pediatric patients with SLE 3, 6, 7.
- The safety profile of belimumab in pediatric patients is similar to that in adult patients 3, 7.
- More research is needed to fully understand the efficacy and safety of belimumab in pediatric patients with SLE and lupus nephritis 4, 5, 6.
Belimumab Pharmacokinetics
- A population pharmacokinetics model of belimumab in pediatric patients with SLE found that fat-free mass better characterized the pharmacokinetics than total body weight 3.
- The model estimated clearance, steady-state volume of distribution, terminal half-life, and distribution half-life in the overall population 3.
- Individual and median steady-state pediatric pharmacokinetic profiles were similar to known adult profiles 3.