#597 Beneficial effects of voclosporin on reducing proteinuria in lupus nephritis and extrarenal effects in SLE: insights form a small cohort with limited follow-up

Abstract Background and Aims Voclosporin, an oral calcineurin inhibitor, is a recently approved drug for treating lupus nephritis (LN), one of the severe manifestations of systemic lupus erythematosus (SLE). This medication has been demonstrated to improve renal remission rates, reduce proteinuria, and preserve renal function in patients with active LN, offering an alternative therapeutic approach, especially in patients with predominant proteinuric LN and without having to report CNI plasmatic levels with fewer secondary effects. We aim to present the most relevant data from a single-centre cohort of our patients who have recently started voclosporin and analyse our real-life experience. Method We performed a retrospective observational study that included patients diagnosed with LN at our centre who initiated voclosporin between June and September 2024. LN diagnosis was confirmed using a combination of clinical, histological, and serological findings, paying attention to dsDNA antibodies. Patients with both newly diagnosed and relapsing were included. Data collected included demographic variables (age, sex, comorbidities) and disease characteristics (LN ISN class and clinical severity). Laboratory markers analysed included serum creatinine, hematuria, leukocyturia, and proteinuria. Treatments, including corticosteroids, rituximab, and cyclophosphamide, were recorded. Safety outcomes included infections, hospitalisations, and mortality during follow-up. Results We included four patients (2 men and 2 women) with a mean age 51 years. 2 had arterial hypertension, none had diabetes. SLE and LN were diagnosed at a mean age of 45 years. Mean baseline creatinine was 0.6 mg/dL, and mean sCr at diagnosis 0.78 mg/dL, with peak value 1.1 mg/dL during flares; follow-up since voclosporin initiation was 6 months. All patients presented with microscopic hematuria and leukocyturia; mean albuminuria was 2.5 g/24 h. Three of them had extrarenal activity. Induction therapy included methylprednisolone 3g in one patient, rituximab in two patients and cyclophosphamide in other two patients. None of the patients required plasma exchange or renal replacement therapy. Three of the patients presented a class V LN with or without an overlapping proliferative class and one patient presented a IV class alone. During follow-up, we observed proteinuria showed rapid improvement, reflecting the mechanisms of voclosporin both as antiproteinuric and disease-controlling agent. One patient presented gingival hyperplasia remembering some patients under cyclosporine which has been controlled with mouth hygiene without voclosporin withdrawal and other patient presented a rash in the hip region which voclosporin collaborated in its improvement. There was no need of withdrawal of the drug due to renal function decline during the 6 months of follow-up. Complement C3 and C4 factors also remained stable and antidsDNA titers diminished steadily. There were not infections or death of any patient during follow-up. Conclusion Our preliminary findings suggest that voclosporin is effective, safe and valuable and provides a prompt improvement in proteinuria and serologic profile with extrarenal benefits in some cases, especially valuable in refractory patients. Further large-scale studies are needed to determine the long-term efficacy and safety and identify subgroups of patients who may benefit the most from it. Even further, despite its posology, patients maintained good compliance with voclosporin.