Safety and efficacy profile of Lupkynis (voclosporin) for people with lupus nephritis presented at European Alliance of Associations for Rheumatology Congress – Aurinia Pharma

Aurinia Pharmaceuticals Inc. announced an oral presentation at the European Alliance of Associations for Rheumatology (EULA R) 2024 taking place in Vienna, Austria June 12-15. The data reinforces previous findings from AURORA Clinical Program on the safety and effectiveness of Lupkynis(voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adult patients with active lupus nephritis.

A propensity analysis comparing the pooled AURA-LV and AURORA 1 studies to the Aspreva Lupus Management Study (ALMS) suggested that a triple immunosuppressive therapy regimen of Lupkynis plus lower-dose MMF and low-dose steroids ( less than 2 g/day) resulted in earlier and greater reductions in proteinuria, reduced cumulative steroid exposure, and demonstrated comparable rates of overall adverse events, compared to dual immunosuppressive therapy regimens combining high-dose glucocorticoids with either higher doses of MMF or cyclophosphamide.

Safety and efficacy outcomes for propensity-matched patients with active LN from ALMS and AURA-LV/AURORA 1 were assessed at three and six months. Patients who received the Lupkynis-based regimen showed greater than 50% reduction in steroid exposure at six months and more frequently achieved a urine protein creatinine ratio (UPCR) of less than 0.5 mg/mg in a faster median time as compared to the high-dose two drug regimen. These patients also achieved greater than 50% UPCR reduction at any time point in the study significantly earlier than their propensity-matched counterparts in ALMS. These findings support guideline recommendations that Lupkynis plus lower-dose MMF and low-dose steroids should be considered as an initial therapy in patients with active LN.