E135 Real-world effectiveness and safety of belimumab in lupus nephritis: first 12-month cohort experience from Central Asia (2024-2025)

Abstract Background/Aims Lupus nephritis is a severe manifestation of systemic lupus erythematosus and remains a major contributor to chronic kidney disease and mortality, particularly in regions where access to biologic therapy is limited. Although clinical trials have established the efficacy of the B-lymphocyte stimulator inhibitor belimumab as an adjunct to standard therapy, evidence from real-world practice in Central Asia has been lacking. This study evaluated the one-year clinical, renal, and serologic outcomes of belimumab treatment in patients with biopsy-proven lupus nephritis in Uzbekistan. Methods A prospective observational cohort study was carried out between January 2024 and March 2025 at Tashkent State Medical University Hospital and ASSA Hospital. Forty-two adult patients with ISN/RPS class III-V lupus nephritis were enrolled. The mean age was 33.5 ± 8.2 years; one participant was male and forty-one were female. All patients received intravenous belimumab at 10 mg/kg every four weeks in addition to mycophenolate mofetil and corticosteroids according to institutional practice. Assessments were performed at baseline, six, and twelve months, including 24-hour urinary protein, serum creatinine, estimated glomerular filtration rate, complement levels (C3 and C4), anti-double-stranded DNA antibodies, and SLEDAI-2K. The primary endpoint was complete renal response or a reduction of at least fifty percent in proteinuria. Secondary outcomes included changes in disease activity, serologic normalisation, and corticosteroid tapering. Results After twelve months, thirty-three of forty-two patients (78.6 percent) achieved renal response, with twenty (47.6 percent) complete and thirteen (31.0 percent) partial responses. Mean proteinuria declined from 2.84 ± 1.32 g/day to 0.82 ± 0.41 g/day (p < 0.001). Serum creatinine decreased from 1.26 ± 0.30 mg/dL to 1.05 ± 0.20 mg/dL (p = 0.02), while estimated glomerular filtration rate increased from 72.4 ± 18.5 to 84.6 ± 16.2 mL/min/1.73 m² (p = 0.01). SLEDAI-2K improved from 14.2 ± 4.5 to 5.6 ± 2.1 (p < 0.001). Complement C3 rose from 0.58 ± 0.17 g/L to 0.94 ± 0.21 g/L (p < 0.001), and C4 from 0.09 ± 0.04 g/L to 0.18 ± 0.05 g/L (p < 0.01). Anti-double-stranded DNA antibodies decreased by 55 percent (p < 0.001). The mean corticosteroid dose was reduced from 24.3 ± 8.6 mg/day to 13.8 ± 6.2 mg/day (p < 0.001), a 43 percent reduction. Adverse events occurred in five patients (11.9 percent), mainly mild infections or fatigue, with no severe infections, hypersensitivity, or deaths. Conclusion This first real-world evaluation of belimumab for lupus nephritis in Central Asia demonstrated significant improvement in renal and systemic outcomes together with a favourable safety and steroid-sparing profile. These findings support the integration of biologic therapy into lupus nephritis management in developing healthcare systems. The author gratefully acknowledges ASSA Hospital for its institutional and logistical support during the study. Disclosure J. Mullokulov: None. I. Turaev: None. S. Rakhimov: None.

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