The Efficacy and Safety of Belimumab in Patients with Lupus Nephritis: A Long-Term, Single-Center Study

This study aims to investigate the efficacy and safety of standard therapy combined with belimumab for the treatment of lupus nephritis over 36 months in a real-world clinical setting.

Ninety-eight patients with lupus nephritis(LN) who underwent renal biopsy at the First Affiliated Hospital of Zhengzhou University between January 2020 and October 2023 were enrolled. They were divided into a control group receiving standard therapy (corticosteroids plus hydroxychloroquine with or without immunosuppressants) and a belimumab group receiving standard therapy combined with belimumab (intravenous infusion on days 1, 14, and 28 at 10 mg/kg, followed by every 28 days). Follow-up ranged from 6 to 36 months. Standard therapy combined with belimumab [intravenous infusion (10 mg/kg on days 1, 14, and 28, followed by every 28 days)]. Patients were followed up for 6–36 months. General characteristics of LN patients in both groups were retrospectively analyzed, and remission rates and adverse event occurrences during LN treatment were compared between groups.

A total of 98 patients with LN were enrolled, comprising 49 in the control group and 49 in the Belimumab group. The median duration of combination therapy in the Belayou group was 21 months. At baseline, both groups were comparable in age, sex, median disease duration, initial steroid dosage, renal AI score, renal CI score, SLEDAI score, white blood cell count, hemoglobin, platelet count, 24-hour urine protein quantification, hematuria, proteinuria, C3, C4, ESR, CRP, procalcitonin, total protein, albumin, globulin, total cholesterol, triglycerides, eGFR, CD19+ B-lymphocyte proportion, anti-dsDNA antibody positivity rate, or renal pathology type (P>0.05). Compared with baseline values, both groups showed a gradual decrease in glucocorticoid dosage during follow-up, with significant increases in hemoglobin, C3, C4, total protein, and albumin, and a significant decrease in 24-hour urine protein quantification (P<0.05). Compared with baseline eGFR values, the Belimumab group showed significant increases at 6, 12, 18, 24, and 30 months (P<0.05), while the control group showed significant improvement only at 6 months (P<0.05). The total renal remission rate in the belimumab group was significantly higher than that in the control group at 6, 12, 18, 24, 30, and 36 months (67.35% vs. 44.9%, 81.63% vs. 59.18%, 81.63% vs. 57.15%, 89.80% vs. 65.31%, 85.71% vs. 69.39%, 87.76% vs. 71.43%; P<0.05). Patients in the belimumab group also demonstrated significantly higher rates of complete renal remission at 6, 12, 18, 24, 30 months (63.27% vs. 38.78%, 75.51% vs. 55.10%, 75.51% vs. 53.06%, 83.67% vs. 61.22%, 83.67% vs. 61.22%; P<0.05). At month 36, the complete renal remission rate in the belimumab group remained higher than that in the control group but did not show statistical significance (79.59% vs. 65.31%, P=0.113). During follow-up, 25 patients in the control group experienced adverse events: 18 cases of pulmonary infection, 5 cases of upper respiratory tract infection, 1 case of urinary tract infection, 3 cases of skin infection/ onychomycosis, and 1 case of bacteremia. In the belimumab group, 23 patients experienced adverse events: 11 cases of pulmonary infection, 5 cases of upper respiratory tract infection, 2 cases of herpes zoster, 3 cases of uterine bleeding, 4 cases of urinary tract infection, and 3 cases of skin infection/onychomycosis. No statistically significant difference in the risk of adverse events was observed between the two groups (P=0.686).

Combination therapy with standard treatment and belimumab achieves a higher rate of renal remission in patients with lupus nephritis, with a risk of adverse events comparable to that of the standard treatment group.