Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
In the phase 3 AURORA 1 trial, adding voclosporin to mycophenolate mofetil and low-dose steroids significantly improved complete renal response rates at 52 weeks in patients with active lupus nephritis, with a safety profile comparable to standard therapy.
Background
Voclosporin is a novel calcineurin inhibitor that had improved complete renal response rates in a phase 2 trial in lupus nephritis. AURORA 1 was designed to confirm its efficacy and safety when added to standard background therapy in patients with active disease.
Study design
This multicentre, double-blind, randomised phase 3 trial was conducted across 142 hospitals and clinics in 27 countries. Eligible patients had systemic lupus erythematosus with biopsy-proven class III, IV, or V lupus nephritis and were randomised 1:1 to oral voclosporin (23.7 mg twice daily) or placebo, on a background of mycophenolate mofetil and rapidly tapered low-dose oral steroids. The primary endpoint was complete renal response at 52 weeks, a composite including a urine protein-creatinine ratio of 0.5 mg/mg or less and stable renal function.
Key findings
Among 357 patients (179 voclosporin, 178 placebo), complete renal response at week 52 was achieved by 41% in the voclosporin group versus 23% in the placebo group (odds ratio 2.65). The adverse event profile was balanced between groups, with serious adverse events in 21% of each arm and pneumonia the most frequent serious infection (4% in each group). Six patients died during the study or follow-up, one in the voclosporin group and five in the placebo group; none of the deaths were considered related to study treatment.
Clinical implications
Voclosporin combined with mycophenolate mofetil and low-dose steroids produced a clinically and statistically superior complete renal response compared with standard therapy alone, with a comparable safety profile. The authors describe this as an important advancement in the treatment of active lupus nephritis.
Category
Research
Source
Lancet
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