American College of Rheumatology Convergence 2021

Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study

Amit Saxena1, Christopher Mela2, Antonia Coeshall2

1NYU Langone Health, Rheumatology, New York, NY, United States, 2Aurinia Pharmaceuticals Inc., Victoria, BC, Canada

Disclosures

Dr. Amit Saxena has participated in advisory boards for Eli Lilly, Bristol Myers Squibb, Kezar Life Sciences and GlaxoSmithKline and in Aurinia clinical trials.

Aurinia provided funding for the study and presentation.

Voclosporin

• Voclosporin is a novel calcineurin inhibitor (CNI) recently

	approved for the treatment of adults with active lupus nephritis in	Voclosporin
	combination with background immunosuppressive therapy1
•	As a CNI, voclosporin has two complementary mechanisms of
	action pertinent to the treatment of lupus nephritis1:
	•	Reduce activation of T-cells
	•	Stabilize podocytes, reducing proteinuria
•	Voclosporin has a consistent dose-concentration relationship,
	eliminating the need for therapeutic drug monitoring1,2
•	Compared to other CNIs, voclosporin is associated with an
	improved lipid and glucose profile and no drug-drug interaction
	with mycophenolate mofetil (MMF)3-6

1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021. 2. van Gelder T et al. JASN. 2020;31:594. 3. Busque S et al. Am J Transplant. 2011;11(12):2675-2684. 4. Kolic J et al. Endocrinology. 2020(161)11.

1. van Gelder T et al. Nephrol Dial Transplant. 2021;gfab022. 6. Rovin BN et al. Lancet. 2021;397(10289):2070-2080.

AURORA 1 Study Design

• AURORA 1 was a Phase 3, global, double-blind,one-yearrandomized-control trial evaluating voclosporin compared to placebo in achieving complete renal response when used in combination with MMF and low-dose oral steroids
• AURORA 1 enrolled patients with biopsy-proven active lupus nephritis, eGFR ≥45 mL/min/1.73 m2 and proteinuria ≥1.5 mg/mg (≥2 mg/mg for Class V)

N=357

Randomization

Voclosporin 23.7 mg BID

MMF 2 g + oral corticosteroids

Control

MMF 2 g + oral corticosteroids

Extension Study

Two-Year

Primary endpoint

52 weeks

BID, twice daily; eGFR, estimated glomerular filtration rate; MMF, mycophenolate mofetil. *Protocol-defined steroid taper included intravenous methylprednisolone 0.25-0.5 g/day administered on Days 1 and 2. Oral steroid 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.

AURORA 1 Primary Outcome

In AURORA 1, compared to MMF and steroids alone, the addition of voclosporin increased complete renal response by 18% at week 52

Composite Primary Outcome

Complete Renal Response at Week 52

• Urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg
• Stable renal function (eGFR ≥60 mL/min/1.73 m2 or no decrease >20% from baseline)
• Presence of sustained, low-dose steroids*
• No rescue medications

Complete Renal Response at Week 52

OR 2.65 (95% CI 1.64, 4.27)

p<0.001

40.8%

22.5%

n=178n=179

	Control		Voclosporin

CI, confidence interval; eGFR, estimated glomerular filtration rate; LN, lupus nephritis; OR, odds ratio.

*Low-dose steroids defined as no more than 10 mg prednisone equivalent per day for ≥3 consecutive days or for ≥7 days in the 8 weeks prior to the primary endpoint assessment.