Safety and efficacy profile of Lupkynis (voclosporin) for people with lupus nephritis presented at EuropeanAlliance of Associations for Rheumatology Congress (EULAR)

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.