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)
*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.