Early antiproteinuric effect of voclosporin in patients with LN in a real-life setting: preliminary results from the VoRLiSS (Voclosporin in Real Life Setting Study) experience

Objective To assess efficacy of voclosporin (VCL) from a retrospective, observational, clinical-practice-based, nationwide multicentre study of patients with LN. Methods Patients with biopsy-proven LN were enrolled from November 2023 to April 2025 from tertiary Rheumatology and Nephrology Italian Centres. Those with uncontrolled arterial hypertension and eGFR<30ml/min/1.73m2 were excluded. Patients received oral 23.7mg VCL BID and MMF 1g BID. Glucocorticoid schedule followed existing recommendations for LN management. Clinical and serological data were collected at SLE diagnosis, VCL initiation and after 6, 12, 24 and 48weeks. Complete renal response (CRR) was defined as eGFR≥60ml/min/1.73m2, <20% eGFR decrease from baseline, 24-h proteinuria <0.5g/day, no rescue therapy, prednisone ≤5mg/day and partial renal response (PRR) as a 50% decrease of 24h proteinuria and <20% eGFR decrease. Results Forty-two patients from 14 centres were enrolled, 26 females (61.9%), mean age 43.1±11.9years, follow-up 6.6±5.1months. A total of 31.5% of patients achieved CRR or PRR at 6weeks, 68.9% at 12weeks, 83.3% at 24weeks and 91.6% at 48weeks of follow-up. A significant decrease in 24-h proteinuria was observed at 6weeks (P=0.006) and at all subsequent time points. A mild eGFR decrease was observed at 6 (P=0.008) and 24weeks (P=0.01), but not at 48weeks. Significant decrease was also observed in anti-dsDNA positivity at 6 (P=0.0016) and 12weeks (P=0.0009), and in SLEDAI-2K after 24 (P=0.008) and 48weeks (P=0.05). Conclusions VCL may provide a valuable therapeutic option in LN management, achieving early 24h-proteinuria response consistent with clinical trial data.