• A propensity analysis of ALMS, AURA-LV, and AURORA 1 suggested that initial therapy with LUPKYNIS plus standard of care reduced exposure to potential toxicities and demonstrated earlier reductions in proteinuria when compared to a conventional regimen consisting of higher doses of both mycophenolate mofetil and glucocorticoids alone.
• A post-hoc analysis showed Black patients experienced improved outcomes and better renal response when using LUPKYNIS.

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.

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

1. Dall’Era M. et al. 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. Presented at the Congress of Clinical Rheumatology East, 2024, Destin, FL.
2. Contreras G. et al. Long-term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis. Presented at the Congress of Clinical Rheumatology East, 2024, Destin, FL.

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