The addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids may help active lupus nephritis patients achieve complete renal remission (CRR), according to findings from a recent trial.
The AURA-LV trial was a phase 2, randomized, double-blind, placebo-controlled trial, which included 265 patients from 79 institutions spanning 20 countries. Patients were randomized to treatment for 48 weeks and received either one of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) or placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids. The primary and secondary outcomes were CRR at 24 weeks and at 48 weeks, respectively.
Voclosporin Effective in #Lupus Nephritis – https://t.co/nYY1C3dVEJ
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After 24 weeks, 32.6% (n = 29) of low-dose voclosporin patients and 27.3% (n = 24) of high-dose voclosporin patients achieved CRR, compared to 19.3% (n = 17) of placebo patients. After 48 weeks, nearly half (49.4%) of low-dose voclosporin patients and 39.8% of high-dose voclosporin patients achieved CRR, versus 23.9% of placebo patients. Patients in both voclosporin groups had higher rates of adverse events; the low-dose voclosporin group had more deaths than the placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively).
“These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active [lupus nephritis] results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed,” the researchers wrote.
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