ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of results from an updated cost-effective analysis of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), at the annual National Kidney Foundation (NKF) Spring Clinical Meeting 2024 taking place in Long Beach, CA, May 14-18. The Company will also share additional data from its AURORA clinical program.
Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN). An updated cost-effectiveness analysis demonstrated that LUPKYNIS continues to be a cost-effective treatment for lupus nephritis (LN). Cost-effectiveness was assessed with the ICER AnalyticsTM LN model and the majority of model assumptions from the original analysis were consistent with the 2021 analysis. Updated inputs in this new analysis included the 2023 cost of LUPKYNIS, the duration of treatment for people who did not respond to treatment, and the cost of treating LN patients with end-stage kidney disease.
LUPKYNIS is substantially below ICER’s willingness-to-pay threshold of $150,000 in adult patients with active LN. The incremental cost of the treatment was $88,076 per quality adjusted life year (QALY) and $77,643 per equal value of life year gained (evLYG) in patients with active LN.
ICER uses a common set of cost-effectiveness thresholds for all assessments, including those for treatments of ultra-rare disorders, providing a uniform range of results from $50,000 to $200,000 per QALY and per evLYG for all assessments. The QALY is the standard for measuring how well various medical treatments lengthen and/or improve patients’ lives, and therefore the metric has served as a fundamental component of cost-effectiveness analyses. To complement the use of the QALY, ICER’s reports also include a calculation of evLYG, which evenly measures any gains in length of life, regardless of the treatment’s ability to improve patients’ quality of life.
Moreover, in a smaller subgroup analysis of Black, Hispanic, and Latino patients — a population disproportionately affected by LN — cost-effectiveness was on par with other interventions for diabetes, blood pressure, and hyperlipidemia. The incremental cost of the treatment per QALY was $77,436 and was $67,828 per evLYG in Black, Hispanic, and Latino patients.
“People living with lupus nephritis must be able to access clinically meaningful treatment options to manage the severity of the disease. When considering LUPKYNIS for their LN patients, physicians can take this cost-effectiveness analysis into account, along with long-term data from our AURORA clinical program, which showed that LUPKYNIS, in combination with MMF and steroids, provided sustained complete renal response and reductions in steroid use over three years of treatment, compared to MMF and steroids alone,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.
An interim assessment of baseline demographics and clinical characteristics of patients currently enrolled in the prospective, observational Enlight-LN registry found that this initial cohort of patients is reflective of the larger LN population in the US. The Enlight-LN registry, designed to characterize the real-world effectiveness profile and usage patterns of LUPKYNIS, is enrolling patients in the US.
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.
Following are the titles and authors of Aurinia’s presentations at NKF’s Spring Clinical Meeting 2024:
Title: Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis
Authors: Ernie Lee, Victoria Atencio, Ronald Flauto, Vanessa Birardi, Lisa Kennedy
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center
Title: Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States
Authors: Stephen Myers, Michelle Zubrycki, Lily Cipolla, Ron Flauto
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center
Title: A propensity Analysis of AURA-LV plus AURORA 1 vs ALMS to Compare a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy
Authors: Kenneth Kalunian, Anca Askanase, Maria Dall'Era, Neil Solomons, Matt Truman, Lucy S Hodge, Ernie Yap
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center
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.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. This may lead to serious, even fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased if administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy that may require antihypertensive therapy. Monitor blood pressure regularly.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause neurotoxicities that if severe can include posterior reversible encephalopathy syndrome, delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium periodically.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia have been reported in patients treated with another CNI. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.
SPECIFIC POPULATIONS
Pregnancy: Avoid use of LUPKYNIS.
Lactation: Consider the benefits and risks of LUPKYNIS and possible risks to the fetus when prescribing LUPKYNIS to a lactating woman.
Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.
Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
References
- Lee E. et al. Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.
- Myers S. et al. Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.
- Kalunian K. et al. A propensity Analysis of AURA-LV plus AURORA 1 vs ALMS to Compare a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.
