Trial Outcomes & Findings for AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV) (NCT NCT02141672)

Eligible subjects were randomized in a ratio of 1:1:1 to receive either voclosporin 23.7 mg BID or 39.5 mg BID, or matching placebo for 48 weeks. All subjects were also to receive 2 g/day MMF. In addition, all subjects were to receive 0.5 g/day IV methylprednisolone on Days 1 and 2 before changing to a reducing course of oral corticosteroid therapy on Day 3.

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.

Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.

Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. Low-dose steroids is defined as use of ≤5 mg prednisone for 8 weeks leading up to the Week 24 visit date or for 12 weeks leading up to the Week 48 visit date.

Time to Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg in the absence of rescue medication.

Time to Sustained Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication.

Sustained early complete remission defined as complete remission that occurred on or before Week 24 and was sustained through Week 48

Time to partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication.

Partial remission is defined as a 50% reduction in UPCR from baseline at Week 24 and Week 48.

Sustained complete remission defined as the first occurrence of complete remission that was sustained through Week 48

Duration of Complete Remission is defined as time of first occurrence of UPCR ≤ 0.5 mg/mg until the second increase above 0.5 mg/mg (i.e. a single occurrence above 0.5 is permitted) or use of rescue medication.

Number of patients with partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction at week 24 or week 48 in the absence of rescue medication.

Time to sustained partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication.

Sustained partial remission defined as the first occurrence of partial remission that was sustained through Week 48

Time to sustained early partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication.

Early partial remission defined as partial remission that occurred on or before Week 24 and was sustained through Week 48

Change from baseline in urine protein creatinine ratio at weeks 24 and 48

The SELENA-SLEDAI assesses disease activity within the last 10 days. Twenty-four items are scored for nine organ systems, and summed to a maximum of 105 points. A score of 6 is considered clinically significant and indicates active disease. For analysis purposes, a score ≥6 was categorized as "high". The 24 items are as follows: seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, and leukopenia.