Effect of long‐term voclosporin treatment on renal histology in patients with active lupus nephritis with repeat renal biopsies

Abstract

ObjectiveThis study characterized the impact of voclosporin on kidney histology in patients with lupus nephritis (LN) who had protocolized repeat kidney biopsies in the AURORA clinical trials.MethodsPatients were randomized to voclosporin or placebo treatment for up to three years; all patients received mycophenolate mofetil and low‐dose glucocorticoids. Patients had baseline kidney biopsies within 6 months prior to study start and repeat biopsies after approximately 18 months of study treatment. The revised NIH indices for LN activity (AI) and chronicity (CI) were calculated, in addition to semi‐quantitative assessment of vascular and tubular lesions.ResultsSixteen patients in the voclosporin group and 10 patients in the control group had both baseline and repeat kidney biopsies. Patient clinical characteristics were similar at baseline. In the voclosporin group, most (n=13) patients had pure class IV lesions (pure class V, n=1; mixed, n=2). In the control group, three patients had pure class IV (pure class III, n=3; pure class V, n=1; mixed, n=3). Most of the voclosporin‐treated patients had no change in CI (n=8) or a change ≤2 (n=6); control‐treated patients also had no change in CI (n=3) or a change ≤2 (n=6). No trends in vascular lesions or tubular compartment changes were observed.ConclusionOutcomes from this small subgroup show exposure to study treatment was not associated with nephrotoxicity based on histopathologic evaluation after 18 months. These data are reassuring and further contribute to the safety profile of voclosporin for the treatment of adults with active LN.