Aurinia Highlights LUPKYNIS® Safety and Efficacy for Lupus Nephritis at 2024 Rheumatology Congress

Aurinia Pharmaceuticals Inc. has presented two significant studies at the 2024 Congress of Clinical Rheumatology (CCR) East in Destin, Florida, from May 9-12. These studies bolster the evidence for the safety and effectiveness of LUPKYNIS (voclosporin) in conjunction with mycophenolate mofetil (MMF) and steroids, specifically for adult patients with active lupus nephritis (LN).

LUPKYNIS, a second-generation calcineurin inhibitor (CNI), was evaluated in combination with standard care in a propensity analysis involving the Aspreva Lupus Management Study (ALMS), AURA-LV, and AURORA 1 studies. The analysis indicated that using LUPKYNIS plus standard care achieved superior reductions in proteinuria and minimized patient exposure to toxicities when compared to higher doses of MMF and glucocorticoids alone. Safety and efficacy outcomes were assessed at three and six months for matched patients with active LN from AURA-LV and AURORA 1 studies. The results showed that patients on the LUPKYNIS regimen had lower exposure to glucocorticoids and more significant reductions in urine protein creatinine ratio from baseline than their counterparts treated with higher doses of MMF and glucocorticoids.

Dr. Greg Keenan, Chief Medical Officer of Aurinia, emphasized that early proteinuria reduction after initial treatment is linked to improved long-term kidney outcomes in LN. These findings support the use of LUPKYNIS plus standard care as an initial treatment option for appropriate LN patients, aligning with the updated 2023 EULAR guidelines. Such insights are expected to aid rheumatologists in devising more effective treatment plans for LN patients.

In a subset analysis of three years of data from the AURORA Clinical Program, it was found that 44.4% of Black patients treated with LUPKYNIS, MMF, and steroids showed improved complete renal response at 36 months, compared to 14.3% of Black patients treated with MMF and glucocorticoids alone. This population, which often faces worse outcomes and lower responses to LN treatment, demonstrated a treatment response consistent with the overall racial and ethnic groups in the AURORA Clinical Program.

LUPKYNIS has been approved by the U.S. Food and Drug Administration and the European Commission as an oral medication for adult patients with active LN. It acts as an immunosuppressant by inhibiting T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, which includes the AURORA 1 pivotal trial and AURORA 2 extension trial, underscores the importance of LUPKYNIS in preserving kidney health without relying on chronic high-dose glucocorticoids. It is notable for being the only clinical program to provide three years of LN treatment and follow-up involving MMF and steroids.

Lupus Nephritis is a severe manifestation of systemic lupus erythematosus (SLE), affecting approximately 120,000 people in the U.S., with a higher prevalence among women and people of color. LN patients often face significant barriers to optimal care and high unmet medical needs. If poorly controlled, LN can lead to irreversible kidney damage. Current medical guidelines recommend routine LN screenings for all SLE patients at every visit to prevent delayed diagnoses, which can result in poor prognoses. However, research indicates that a significant portion of SLE patients do not receive regular LN screenings, and many with LN remain untreated.

Aurinia Pharmaceuticals is dedicated to improving health outcomes for LN patients by raising awareness among patients and healthcare providers about the importance of routine screenings and effective therapies. The company's commitment is evident in their ongoing efforts to deliver targeted therapies for autoimmune, kidney, and rare diseases, especially through the introduction of LUPKYNIS in 2021, marking the first FDA-approved oral therapy for adult patients with active LN.