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 < 30 ml/min/1.73 m2 were excluded. Patients received oral 23.7 mg VCL BID and MMF 1 g 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 48 weeks. Complete renal response (CRR) was defined as eGFR >= 60 ml/min/1.73 m2, <20% eGFR decrease from baseline, 24-h proteinuria <0.5 g/day, no rescue therapy, prednisone <= 5 mg/day and partial renal response (PRR) as a 50% decrease of 24 h proteinuria and <20% eGFR decrease.Results Forty-two patients from 14 centres were enrolled, 26 females (61.9%), mean age 43.1 +/- 11.9 years, follow-up 6.6 +/- 5.1 months. A total of 31.5% of patients achieved CRR or PRR at 6 weeks, 68.9% at 12 weeks, 83.3% at 24 weeks and 91.6% at 48 weeks of follow-up. A significant decrease in 24-h proteinuria was observed at 6 weeks (P = 0.006) and at all subsequent time points. A mild eGFR decrease was observed at 6 (P = 0.008) and 24 weeks (P = 0.01), but not at 48 weeks. Significant decrease was also observed in anti-dsDNA positivity at 6 (P = 0.0016) and 12 weeks (P = 0.0009), and in SLEDAI-2K after 24 (P = 0.008) and 48 weeks (P = 0.05).Conclusions VCL may provide a valuable therapeutic option in LN management, achieving early 24 h-proteinuria response consistent with clinical trial data.
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
Calatroni, Marta;Moroni, Gabriella
2026-01-01
Abstract
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 < 30 ml/min/1.73 m2 were excluded. Patients received oral 23.7 mg VCL BID and MMF 1 g 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 48 weeks. Complete renal response (CRR) was defined as eGFR >= 60 ml/min/1.73 m2, <20% eGFR decrease from baseline, 24-h proteinuria <0.5 g/day, no rescue therapy, prednisone <= 5 mg/day and partial renal response (PRR) as a 50% decrease of 24 h proteinuria and <20% eGFR decrease.Results Forty-two patients from 14 centres were enrolled, 26 females (61.9%), mean age 43.1 +/- 11.9 years, follow-up 6.6 +/- 5.1 months. A total of 31.5% of patients achieved CRR or PRR at 6 weeks, 68.9% at 12 weeks, 83.3% at 24 weeks and 91.6% at 48 weeks of follow-up. A significant decrease in 24-h proteinuria was observed at 6 weeks (P = 0.006) and at all subsequent time points. A mild eGFR decrease was observed at 6 (P = 0.008) and 24 weeks (P = 0.01), but not at 48 weeks. Significant decrease was also observed in anti-dsDNA positivity at 6 (P = 0.0016) and 12 weeks (P = 0.0009), and in SLEDAI-2K after 24 (P = 0.008) and 48 weeks (P = 0.05).Conclusions VCL may provide a valuable therapeutic option in LN management, achieving early 24 h-proteinuria response consistent with clinical trial data.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
