PO:17:255 | Efficacy and safety of voclosporin in the management of lupus nephritis: a case series

Alessandra Oliva¹, Elisabetta Chessa², Marta Paola Pireddu¹, Marianna Salis¹, Giulia Rizzo¹, Fabio Congiu¹, Elena Ragusa¹, Antonello Pani^3|4, Alberto Cauli^1|2, Nicola Lepori^3|4, Matteo Piga^1|2 | ¹UOC Reumatologia, Dipartimento di Scienze Mediche e Salute Pubblica, Università degli Studi di Cagliari; ²UOC Reumatologia, AOU Cagliari; ³SC Nefrologia e Dialisi, Università degli Studi di Cagliari; ⁴SC Nefrologia e Dialisi, Azienda Ospedaliera Brotzu, Cagliari, Italy

Background. Voclosporin (VOC) is a new drug approved for treating and managing lupus nephritis (LN) in patients with Systemic Lupus Erythematosus (SLE), according to EULAR recommendations. The aim of this study is to describe a case series of patients with long-standing SLE treated with VOC for active LN, refractory to multiple therapies, and persistent proteinuria.

Materials and Methods. Demographic, clinical, histological, therapeutic and comorbidity data were recorded for patients with SLE (2019 EULAR/ACR criteria) treated with VOC, who were followed at our Lupus Clinic in collaboration with Nephrologists. A descriptive analysis of the cases was conducted.

Results. Characteristics of 3 patients (2F, 1M), with a mean disease duration of 22.33±12.01 years at enrolment, are reported in the Table and Figures. Case 1 (F, 74 years old): patient with 34-year history of SLE with renal, articular, cutaneous and pulmonary involvement. In 2024, she developed nephrotic syndrome (proteinuria: 5 g/day). A renal biopsy was performed, revealing a class V LN. She was treated with mycophenolate mofetil (MM) 2 g/day and ramipril 5 mg/day with little benefit (proteinuria: 2.58 g/day after 6 months). Following discussion of the case with Nephrologists, she began therapy with VOC, leading to a rapid reduction in proteinuria (0.6 g/day after 1 month and 0.22 g/day after 6 months) and achievement of remission according to DORIS criteria (REM). Despite good subjective tolerance, the patient experienced an increase in serum creatinine (from 0.6 to 1.0 mg/dl) with a GFR of 58 ml/min, which required refinement of antihypertensive therapy. Case 2 (F, 57 years old): SLE onset with nephrotic syndrome in 2014; in 2021 she presented with a relapse, and renal biopsy showed mesangioproliferative LN (Class II). She started treatment with belimumab, suspended after 3 months due to intolerance (fever, arthralgia, and general malaise). She was then started on VOC, with a subsequent reduction in proteinuria in 4 months (from 0.95 to 0.38 g/day) and achievement of REM. The patient reported hypertrichosis on the upper limbs. Case 3 (M, 54 years old): patient with LN with a relapsing-remitting course (renal biopsy in 2001: class IV LN; in 2008: class IIIA; in 2020: class II). He was treated with cyclophosphamide, azathioprine and glucocorticoids. Due to persistent proteinuria, he started MM but showed worsening values (2,59 g/day), for which he started VOC (a biopsy was not performed due to a nephrological contraindication): in 4 months proteinuria decreased from 2.44 to 0.38 g/day, and REM was achieved. Nevertheless, serum creatinine increased and hypertension worsened, therefore amlodipine was added.

Conclusions. Despite the brief clinical follow-up, VOC has proven effective in reducing proteinuria and glucocorticoid doses in patients with multi-refractory LN. However, adverse effects have emerged, thus close clinical-laboratory monitoring is considered necessary.