ROCKVILLE, EDMONTON - Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12.
The data reinforce previous findings on the safety and effectiveness of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), in combination with MMF and steroids, for the treatment of adult patients with active lupus nephritis (LN), as shown in the AURORA Clinical Program.
A propensity analysis of the Aspreva Lupus Management Study (ALMS), AURA-LV, and AURORA 1 studies suggested that LUPKYNIS plus standard of care demonstrated superior reductions in proteinuria and reduced patient exposure to toxicities compared with higher doses of mycophenolate mofetil (MMF) and glucocorticoids or cyclophosphamide and glucocorticoids alone. Safety and efficacy outcomes for propensity-matched patients with active LN from the AURA-LV plus AURORA 1 studies were assessed at three and six months. Patients who received the LUPKYNIS-based regimen experienced reductions in exposure to glucocorticoids and more patients achieved a >50% urine protein creatinine ratio reduction from baseline compared to their propensity-matched counterparts in ALMS.
'Early reduction in proteinuria after initial treatment has been associated with improved long-term kidney outcomes in lupus nephritis,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. 'These data provide further support for use of LUPKYNIS plus standard of care as an initial treatment option for appropriate patients with active LN, consistent with the updated 2023 EULAR guidelines. These insights should help rheumatologists implement more effective treatment plans for their LN patients.'
In a subset analysis of three years of data from the AURORA Clinical Program, 44.4% of Black patients treated with LUPKYNIS, MMF, and steroids experienced an improvement in complete renal response at 36 months (n=18) compared to 14.3% of Black patients who achieved complete renal response when treated with MMF and glucocorticoids alone (n= 7 OR: 4.17 (CI 0.41, >9.99), p=0.22). These findings among Black patients, a population that often experiences worse outcomes and lower responses to LN treatment, are consistent with the treatment response seen across all racial and ethnic groups treated with the addition of LUPKYNIS to the standard of care in the AURORA Clinical Program.
Following is the complete guide to Aurinia's presentations at CCR East 2024
Title: Comparison of a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy: A Propensity Analysis of the AURA-LV plus AURORA 1 Studies and ALMS
Authors: Maria Dall'Era, Kenneth Kalunian, Anca Askanase, Neil Solomons, Matt Truman, Lucy S. Hodge, Ernie Yap
Date: Friday, May 10, 2024
Time: 2:45 p.m. - 5:00 p.m. CT
Title: Long-term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis
Authors: Gabriel Contreras, Matthew G. Baker, Lucy S. Hodge, Ernie Yap
Date: Friday, May 10, 2024
Time: 2:45 p.m. - 5:00 p.m. CT
About LUPKYNIS
LUPKYNIS (voclosporin) is the first U.S. Food and Drug Administration and European Commission approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids.
About Lupus Nephritis
Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with high unmet medical needs that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company's head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
Contact:
Andrea Christopher
Email: achristopher@auriniapharma.com
AURINIA PHARMACEUTICALS INC. 
