Efficacy and Safety of Belimumab in Lupus Nephritis Patients: A Real-World Observational Study in China

This study aimed to describe disease activity, clinical outcome, and overall patterns of lupus nephritis care in patients who received belimumab in a real-world clinical setting in China.

This observational cohort study included lupus nephritis patients who received belimumab as adjunct therapy. We deeply investigated the characteristics of those patients including clinical response to belimumab and safety.

All 61 lupus nephritis patients were included with a median follow-up period of 9 months (6, 19). Prevalence of proteinuria (52.5-24.6%) and hematuria (33.3-9.8%) was decreased with a stable level of eGFR at last visit. The percentage of patients achieved complete or partial renal response increased from 47.5% to 78.7% and the proportion of complete or partial renal response in patients with proliferative lupus nephritis was higher than those with membranous lupus nephritis (75 vs. 50%) at last visit. The median SLEDAI score decreased from 6 to 2, and there was an increase in patient of LLDAS from 17 to 33 at last visit. A notable dose reduction was seen for glucocorticosteroid dose, with a median change from 10 to 5 mg/d. The proportion of patients receiving >7.5 mg/d steroids reduced from 52.5% at baseline to 23.0% at last visit. The discontinuation of belimumab was rare (3/61) for drug-induced fever, hyperthyroidism, and uveitis.

Lupus nephritis patients with belimumab demonstrated improvements in clinical response and a reduction in glucocorticosteroids, which provided evidence of effectiveness and safety in real-world clinical practice in China.