Updated interim results from the AURORA 2 continuation study of Lupkynis for the treatment of lupus nephritis.
The updated results will be presented virtually on Nov. 8 during Plenary Session III at 10:45 a.m. EST during The American College of Rheumatology (ACR) Convergence 2021.
In the interim analysis, patients in the voclosporin group maintained meaningful reductions in proteinuria. From pre-treatment baseline in AURORA 1 to month 30 in AURORA 2, mean urine protein/creatinine ratio (UPCR) was -3.32 mg/mg for the voclosporin group (n=90) and -2.55 mg/mg for the control group (n=78). In the voclosporin group, estimated glomerular filtration rate (eGFR), an important measurement of kidney function, remained stable through month 30. There were no unexpected new adverse events reported in the voclosporin group compared to the control group.
AURORA 2 (NCT03597464) is a Phase III randomized, double-blind, placebo-controlled clinical trial to assess the long-term safety and tolerability of voclosporin, in addition to the standard of care, for the treatment of LN in patients with SLE. Patients who completed 12 months of treatment in the Phase III AURORA 1 study were eligible to enroll in the AURORA 2 continuation study with the same randomized treatment of voclosporin at 23.7 mg twice daily or placebo, in combination with mycophenolate mofetil (MMF) at 1 g twice daily with either no or low-dose oral steroids, for an additional 24 months.
A total of 216 LN patients continued into AURORA 2, with 116 patients in the voclosporin group and 100 patients in the control group. 90 and 78 patients, respectively, received 30 months of total treatment as of this interim analysis. Final results from the AURORA 2 study are expected by the end of 2021.
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