RT Journal Article
SR Electronic
T1 1007 Voclosporin for lupus nephritis: assessment of long-term safety and efficacy including renal outcome over three years of treatment in the phase 3 AURORA 1 and AURORA 2 studies
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP A85
OP A85
DO 10.1136/lupus-2023-lupus21century.73
VO 11
IS Suppl 2
A1 Parikh, Samir V
A1 Arriens, Cristina
A1 Hodge, Lucy
A1 Mela, Christopher M
A1 Leher, Henry
YR 2024
UL http://lupus.bmj.com/content/11/Suppl_2/A85.1.abstract
AB Background In AURORA 1, adding voclosporin to mycophenolate mofetil (MMF) and low-dose steroids led to signficant reductions in proteinuria at one year in patients with lupus nephritis (LN). We report on the recently completed AURORA 2 study evaluating voclosporin compared to placebo in patients treated for an additional two years after AURORA 1.Methods Patients with LN completing AURORA 1 were eligible to continue on the same double-blinded treatment of voclosporin or placebo in AURORA 2; all patients recieved MMF and low-dose steroids. Outcomes assessed over the three year treatment period of both studies included adverse events (AEs), eGFR, urine protein-creatinine ratio (UPCR), good renal outcome and renal flare. Good renal outcome was defined based on achievement of an adequate response (i.e. sustained reduction in UPCR to ≤0.7 mg/mg) and without renal flare (i.e. an increase to UPCR >1 mg/mg from a post-response UPCR of <0.2 mg/mg or an increase to UPCR >2 mg/mg from a post-response UPCR of 0.2 to 1.0 mg/mg), as adjudicated by a blinded Clinical Endpoints Committee.Results Overall rates of serious AEs in the voclosporin (26.7% of 116 patients) and control arm (28.0% of 100 patients) were similar. There were no deaths in the voclosporin arm during AURORA 2; four deaths occured in the control arm (pulmonary embolism, n=1; coronavirus infection, n=3). Mean corrected eGFR was within the normal range and stable over the study period. The reductions in UPCR achieved in AURORA 1 were maintained in AURORA 2 and significantly more patients in the voclosporin arm achieved a good renal outcome (66.4% in voclosporin vs 54.0% in control; p-value=0.045). Renal flare occurred in 24 of 101 patients with adequate response in the voclosporin arm and 19 of 73 patients in the control arm (23.8% in voclosporin vs 26.0% in control; p-value=0.662); 69.8% of all patients with renal flares completed study treatment.Conclusions Voclosporin was well-tolerated over three years of treatment. The significant reductions in proteinuria initially achieved in AURORA 1 were maintained throughout AURORA 2 and more patients in the voclosporin arm achieved a good renal outcome. These data provide evidence of a long-term treatment benefit of voclosporin in patients with lupus nephritis.