LUPKYNIS (voclosporin) Achieved Significantly Higher Renal Response in Lupus Nephritis Patients with High Proteinuria Compared to Patients Treated with MMF and Low Dose Steroids Alone - Seite 2

About the Analysis

To further characterize the efficacy and safety of voclosporin in patients with high proteinuria, outcomes were analyzed in various subpopulations of patients with UPCR ≥2 g/g at baseline using the pooled dataset from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies.

Both studies enrolled patients with biopsy-proven LN (Class III, IV, or V ± III/IV) within 6 months (or up to 2 years in AURORA 1) and proteinuria ≥1.5 g/g (≥2 g/g for Class V). Patients were randomized to voclosporin (23.7 mg BID) or placebo and treated for up to one year (48 weeks in AURA-LV and 52 weeks in AURORA 1). All patients received MMF and low-dose steroids. Protocol-defined glucocorticoid taper included intravenous methylprednisolone on Days 1 and 2. Oral glucocorticoid was initiated on Day 3 with 20-25 mg/day prednisone and tapered to a target dose of 2.5 mg/day at Week 16 and thereafter.

For the analysis, complete renal response (CRR) rates were evaluated in patients with baseline UPCR ≥2 g/g. CRR was defined as UPCR ≤0.5 g/g with stable renal function, low-dose steroids, and no rescue medication. Subgroup analyses were based on sex, age, race, ethnicity, biopsy class, and estimated glomerular filtration rate (eGFR) at baseline. Adverse events (AEs) and mean eGFR levels over time were also assessed.

Of the 268 and 266 patients included in the voclosporin and control arms of the pooled analysis, respectively, 217 and 215 patients had a baseline UPCR ≥2 g/g (mean [SD], 5.1 [3.3] vs. 4.6 [2.8] g/g, respectively). At one year, the change from baseline in least squares mean UPCR was -3.8 (0.1) g/g in the voclosporin arm, compared to -3.1 (0.2) g/g in the control arm (difference vs. control, -0.7; p=0.0003).

A significantly greater percentage of voclosporin-treated patients achieved CRR at one year compared to the control arm (41.0% vs. 21.9%; odds ratio [OR] 2.48). Across biopsy classes, the highest rates of CRR were observed in Class III patients treated with voclosporin (50% vs. 16.1% in control, p=0.0126), followed by Class IV (44% vs. 23.8%, p=0.0019), Class V with III or IV lesions (37.7% vs. 17% p=0.0306), and Class V (31.3% vs. 28.6%, p=0.81).

CRR rates were numerically greater in subgroups of voclosporin-treated patients, including both sexes and across all ages, races, ethnicities, biopsy classes, and eGFR levels assessed, as indicated with OR>1.

Similar rates of AEs were reported in both arms and mean eGFR levels were similar and stable over one year of treatment.

About Lupus Nephritis

Lupus Nephritis is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S., and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, lupus nephritis can lead to permanent and irreversible tissue damage within the kidney. Black and Asian people with SLE are four times more likely to develop lupus nephritis and Hispanic people are approximately twice as likely to develop the disease compared to White people with SLE. Black and Hispanic people with SLE also tend to develop lupus nephritis earlier and have worse outcomes, compared to White people with SLE.