American Society of Nephrology Kidney Week 2021

Voclosporin is Effective in Achieving Complete Renal Response in Severe Lupus Nephritis

Hanni Menn-Josephy1,

Matt Truman2, Mary Palmen2, Paola Mina-Osorio3

1Boston University School of Medicine, Boston, MA, 2Aurinia Pharmaceuticals Inc., Victoria, BC, 3Aurinia Pharmaceuticals Inc., Rockville, MD

Disclosures

Affiliation/Financial Interest	Organization
Consultancy	Aurinia Pharmaceuticals
Consultancy, Medical Education Board	GlaxoSmithKline (GSK)
Clinical trials, Co-PI	Astra-Zeneca
Clinical trials, Co-PI	Biogen
Clinical trials, Co-PI	Human Genome Sciences
Clinical trials, Co-PI	Pfizer
Clinical trials, Co-PI	Merck Pharmaceuticals

Aurinia Pharmaceuticals provided funding for the study and presentation.

Voclosporin

Voclosporin

• Voclosporin is a novel calcineurin inhibitor (CNI) recently approved for the treatment of adults with lupus nephritis1
• Voclosporin has a consistent dose-concentration relationship, eliminating the need for therapeutic drug monitoring1,2
• Compared to other CNIs, voclosporin has an improved lipid and glucose profile and no drug-drug interaction with mycophenolate mofetil (MMF)3-5

		Voclosporin has two separate mechanisms of action
1	Inhibition of calcineurin	2	Inhibition of calcineurin stabilizes
reduces activation of T-cells	podocytes, reducing proteinuria

1. LUPKYNIS (package insert) Rockville, MD: Aurinia Pharma U.S., Inc. 2021. 2. van Gelder T et al. J Am Soc Nephrol. 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):bqaa162. 5. van Gelder T et al. Nephrol Dial Transplant. 2021;gfab022.

AURORA 1 Study Design

AURORA 1 was a global, double-blind,randomized-control Phase 3 trial evaluating the efficacy and safety of voclosporin compared to placebo in achieving complete renal response in patients with active lupus nephritis when used in combination with MMF and rapidly tapered low-dose oral steroids

Randomization

N=357

Voclosporin 23.7 mg BID

MMF 2 g + oral corticosteroids		Two-Year
		Extension Study
Control
MMF 2 g + oral corticosteroids
Secondary endpoint	Primary endpoint
24 weeks	52 weeks

MMF, mycophenolate mofetil. *Intravenous methylprednisolone 0.25-0.5 g/day administered on Days 1 and 2. Oral steroid initiated on Day 3 with 20-25 mg/day prednisone and rapidly tapered to a target dose of 2.5 mg/day at Week 16. At Week 52, 70.2% and 66.0% of control- and voclosporin- treated patients with severe disease were on a dose ≤2.5 mg/day compared with 70.2% and 84.4%, respectively, of patients with non-severe disease.

AURORA 1 Study

Key Inclusion Criteria

• Biopsy-provenactive lupus nephritis (Class III, IV or V)
• Proteinuria ≥1.5 mg/mg (≥2 mg/mg for Class V)
• eGFR >45 mL/min/1.73 m2

Composite Primary Outcome

Complete Renal Response at Week 52

• Urinary 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

N=357

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.