PO:26:092 | Early antiproteinuric effect of voclosporine in patients with lupus nephritis in real life setting: preliminary results from the VoRLiSS (Voclosporine in Real Life Setting Study)

Aurora Di Gregorio¹, Marta Calatroni², Marco Allinovi³, Alessandra Bortoluzzi⁴, Giorgio Buscetta⁵, Rossella De Angelis⁶, Ginevra De Marchi⁷, Giacomo Emmi⁸, Pasquale Esposito⁹, Paride Fenaroli¹⁰, Micaela Fredi¹¹, Giovanni Orsolini¹², Giulia Pazzola¹³, Domenico Santoro¹⁴, Andrea Doria¹, Gabriella Moroni², Luca Iaccarino¹ | ¹Azienda Ospedaliera Universitaria Padova, Italy; ²Ospedale IRCCS Humanitas Milano, Italy; ³Azienda Ospedaliero Universitaria Careggi Firenze, Italy; ⁴Azienda Ospedaliero Universitaria di Ferrara, Italy; ⁵Policlinico Universitario Paolo Giaccone Palermo, Italy; ⁶Università Politecnica delle Marche Ancona, Italy; ⁷Università di Udine, Italy; ⁸Università di Trieste, Italy; ⁹Università di Genova, Italy; ¹⁰Unità di Nefrologia AUSL IRCCS di Reggio Emilia, Italy; ¹¹Università di Brescia, Italy; ¹²Università di Verona Verona, Italy; ¹³Università di Reggio Emilia, Italy; ¹⁴Azienda Ospedaliera Universitaria G. Martino di Messina, Italy

Aim of the Study. To assess efficacy of voclosporin from a retrospective, observational, clinical-practice based, nationwide multi-center study of patients with lupus nephritis.

Methods. Patients were treated with voclosporin plus mofetil mycophenolate (2g/day) from November 2023 to April 2025 at referral rheumatologic and nephrologic Centers. Inclusion criteria were: fulfilment of the existing classification criteria for SLE, biopsy proven active renal disease, eGFR >30 ml/min/1.73m2, 24h-proteinuria at least 1 g/day. Exclusion Criteria was uncontrolled arterial hypertension. Patients received 23.7 mg voclosporin twice daily and concomitantly MMF 1 g twice daily. Glucocorticoid schedule followed daily clinical practice, based on existing recommendations for management of lupus nephritis. Clinical and serological data were collected at voclosporin initiation and during follow-up (2, 3, 6 and then every 6 months). Variables included in this analysis were: proteinuria, serum creatinine and eGFR. Primary outcome was Complete Renal Response (CRR): 24h-proteinuria <0.5 g/day or UPCR <0.5 mg/mg, eGFR>60ml/min/1.73m2, <20% eGFR decrease from baseline, no rescue therapy, prednisone = 5 mg/day. Secondary outcome was Partial Renal Response (PRR): 50% decrease of 24h-proteinuria or UPCR and <20% eGFR decrease.

Results. Forty-two patients form 13 Centers were enrolled, 26 females (61.9%), mean age 43.1±11,9 years. The mean age at diagnosis of lupus was 30±12.8 years. Mean follow-up was 6.6 ±5.03 months. Different histological classes are reported in Fig.1. A significant decrease in 24-hour proteinuria was observed between baseline and 2 months of follow-up (p=0.0169). Among 24 patients who achieved at least 6 months of follow-up the decrease of 24h proteinuria is reported in Figure 2 as well as the decrease of eGFR in Figure 4. Distribution of CRR and PRR at two, three and six months is reported in Figure 3. Significant differences were observed also for eGFR (p=0.004), C3 (p=0.034), and SLEDAI-2K (p=0.038) between baseline and 2 months of follow-up. Notably, higher baseline proteinuria was associated with a lower likelihood of achieving complete renal response at 2 months (p=0.034, OR=0.3), suggesting a potential predictive role.

Conclusions. Our preliminary findings suggest that voclosporin may provide a valuable therapeutic option in LN management, with promising early renal responses consistent with clinical trial data.