Belimumab in Pediatric SLE: Long-Term Real-World Meta-Analysis

Key Takeaways

• Across follow-up, pooled pediatric data showed lower disease activity and higher LLDAS attainment with belimumab.
• Glucocorticoid dose was lower than baseline at 6 and 12 months, and the reported 12-month flare rate was 7%.
• Adverse events were reported at 6 and 12 months, and double-arm comparisons favored belimumab over standard immunotherapy for several outcomes.

In a Rheumatology meta-analysis, children with systemic lupus erythematosus receiving belimumab had a 17.71-point reduction in SLEDAI from baseline at 12 months. The pooled analysis drew on pediatric cohorts and trials with 6- and 12-month follow-up.

This analysis included 16 cohort studies and trials evaluating belimumab, the first biologic approved for children 5 years and older with SLE. Random-effects models were used for single-arm analyses, with risk ratios and mean differences calculated for double-arm comparisons. Single-arm estimates reflected within-group changes over follow-up, while double-arm analyses compared belimumab with standard immunotherapy.

At 6 months, pooled SLEDAI was 10.16 points lower than baseline. LLDAS was reached by 42% at 6 months and 79% at 12 months. Mean glucocorticoid dose fell by 19.88 mg/day at 6 months and 11.84 mg/day at 12 months. By 12 months, disease activity remained below baseline, matching the larger reduction highlighted in the lead. Overall, the pooled findings showed lower disease activity over follow-up alongside reduced glucocorticoid exposure.

The pooled adverse event rate was 12% at 6 months and 46% at 12 months. In children with lupus nephritis, complete remission occurred in 88% at 6 months and 94% at 12 months.

In double-arm comparisons with standard immunotherapy, belimumab was associated with a greater SLEDAI reduction at 6 months (MD, 2.86; P <0.001). It was also associated with fewer adverse events (RR, 0.37; P =0.004). At 6 months, lupus nephritis remission was higher with belimumab (RR, 1.26; P =0.03). At 12 months, flare risk was lower with belimumab than with standard immunotherapy (RR, 0.44; P =0.02).

The authors concluded that add-on belimumab was associated with better overall disease control and safety at 6 months and lower flare risk at 12 months.