Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison

• DOI: 10.1136/rmdopen-2021-001747
• Publication Date: 2021-09-16T16:48:50Z
• Authors: Hermine I Brunner; Carlos Abud-Mendoza; Masaaki Mori; Clarissa A Pilkin...; Reema Syed; Syuji Takei; Diego O Viola; Richard A Furie; Sandra Navarra; Fengchun Zhang; Damon L Bass; Gina Eriksson; Anne E Hammer; Beulah N Ji; Mohamed Okily; David A Roth; Holly Quasny; Nicolino Ruperto
• Keywords: Belimumab; Systemic lupus

Objective To assess the efficacy and safety of belimumab in paediatric versus adult patients with systemic lupus erythematosus (SLE). Methods We performed across-study comparisons active SLE who received or placebo, plus standard therapy, PLUTO (paediatric phase II) BLISS-52, BLISS-76, BLISS-NEA EMBRACE (adult III). Analysed data included Week 52 Responder Index (SRI)-4 response rate (EMBRACE: SRI modified Systemic Lupus Erythematosus Disease Activity (SLEDAI) proteinuria scoring (SRI-S2K)); SRI-4 SRI-S2K) according to baseline disease activity indicators (Safety Estrogens National Assessment-Systemic (SELENA-SLEDAI) score; anti-dsDNA/C3/C4 levels); SRI-6 rate; time first severe flare (SELENA-SLEDAI Flare Index) over weeks. Safety were compared for all aforementioned studies along LBSL02 (phase BLISS-SC Results rates similar across studies; more belimumab-treated achieved responses placebo (PLUTO: 52.8% vs 43.6%; BLISS-52: 57.6% BLISS-76: 43.2% 33.8%; BLISS-NEA: 53.8% 40.1%; EMBRACE: 48.7% 41.6%). Across studies, generally greater SELENA-SLEDAI scores ≥10 than ≤9. A proportion 41.2%; 46.2%; 33.1%; 43.9%; 37.5%). Belimumab reduced risk studies. The incidence adverse events was Conclusions These analyses demonstrate consistent therapy SLE. Trial registration numbers ( NCT01649765 ); BLISS-52 NCT00424476 BLISS-76 NCT00410384 NCT01345253 NCT01632241 NCT01484496 NCT00071487 ).