VOCLOSPORIN WAS EFFECTIVE AND SAFE IN TREATING LUPUS NEPHRITIS, ALSO IN PATIENTS WHO HAD PREVIOUSLY FAILED OTHER IMMNOSUPPRESSANTS AND BIOLOGICS. A SINGLE-CENTER REAL-WORLD EXPERIENCE.

PV133 / #80 Poster Topic: AS15 - Lupus Nephritis-Clinical Background/Purpose Voclosporin, a new calcineurin inhibitor, has demonstrated efficacy in clinical trials, but real-world data on its use are limited. Our aim was to evaluate the effectiveness of voclosporin in combination with MMF in reducing proteinuria and preserving renal function in patients with lupus nephritis (LN). In addition, to evaluate its safety in a real-world setting. Methods This retrospective analysis of perspectively collected data included patients with LN treated with voclosporin at a single center. Clinical and laboratory data, including 24-hour proteinuria, estimated glomerular filtration rate (eGFR), and prednisone dose, were collected at baseline and at 2, 4, 6, and 9 months of follow-up. Complete renal response (CRR) was defined as 24-hour proteinuria <0.5 g/day, stable or improved renal function (eGFR), and inactive urinary sediment. Results Eight patients were included: median age 44 years (IQR 28.7-48.7), mean disease duration 11.6±6.9 years, 62.5% Caucasians, 62.5% class IV LN, 37.5% combination of class IV and V LN. Most patients had previously failed MMF as induction therapy (87.5%), with some also failing belimumab (62.5%), rituximab (37.5%), or tacrolimus (Table 1). After voclosporin initiation, the mean 24-hour proteinuria decreased from 2.3±0.74 g at baseline to 1.0±0.72 g at 2 months, 0.64±0.52 g at 4 months, 0.47±0.36 g at 6 months, and 0.47±0.22 g at 9 months. A ≥50% reduction in proteinuria was observed in 71.5% of patients at 2 months, and 100% at 6 months. Proteinuria <0.5 g/24-hour was achieved as early as at month 2 in 71.4% of patients. CRR was achieved in 66% of patients at 6 months and in 75% at 9 months. Renal function remained stable with no significant changes in eGFR. Prednisone was tapered to a mean of 5 mg/day at 4 months and 2.5 mg/day at 6 months. No adverse events were reported, including no significant worsening of comorbidities, including preexistent hypertension (3 cases), dyslipidemia (2 cases) or diabetes (1 case). Table 1. Characteristics of the 8 patients treated with voclosporin from November 2023 to October 2024. Conclusions Voclosporin in combination with MMF was effective in reducing proteinuria and preserving renal function in LN patients, even in those who have failed prior therapies. The treatment was well tolerated and allowed for significant corticosteroid tapering, supporting its use in clinical practice as a valuable option for managing lupus nephritis.

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