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
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.
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)
*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.
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Aurinia Pharmaceuticals Inc. published this content on 08 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 November 2021 16:07:15 UTC.
Aurinia Pharmaceuticals Inc. is a Canada-based fully integrated biopharmaceutical company. The Company is focused on delivering therapies to treat targeted patient populations with a high unmet medical need that are impacted by autoimmune, kidney and rare diseases. The Company has developed LUPKYNIS (voclosporin), an oral therapy for the treatment of adult patients with active lupus nephritis (LN) and continues to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program. LUPKYNIS is a calcineurin inhibitor (CNI) immunosuppressant, that improves near and long-term outcomes in LN when used in combination with mycophenolate mofetil (MMF) and steroids. LUPKYNIS reduces cytokine activation and blocks interleukin IL-2 expression and T-cell mediated immune responses. Voclosporin, the active ingredient in LUPKYNIS, is made by a modification of a single amino acid of the cyclosporine molecule. Its product pipeline includes AUR200 and AUR300.