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Printed Nov 15, 2024 • 7 minute learn
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ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Prescription drugs Inc. (NASDAQ: AUPH) (Aurinia or the Firm), introduced at this time the acceptance of 4 poster displays on the annual American Faculty of Rheumatology Convergence (ACR) 2024 going down in Washington, D.C., November 14-19. The info spotlight the necessity for extra screening for lupus nephritis (LN), a severe manifestation of systemic lupus erythematosus (SLE), and reinforce the scientific significance of LUPKYNIS® (voclosporin), a second era calcineurin inhibitor (CNI), for the remedy of adults with lively LN.
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“The info we’re presenting at ACR spotlight the pivotal function the rheumatology group should play in diagnosing and managing lupus nephritis. Rheumatologists are on the frontlines of guaranteeing early detection by means of routine screenings and of managing LN appropriately with LUPKYNIS, which is backed by strong scientific and real-world proof,” stated Dr. Greg Keenan, Chief Medical Officer of Aurinia.
New real-world demographic knowledge spotlight excessive prevalence of LN amongst folks with SLE
Utilizing the American Rheumatology Community (ARN) digital medical data database to know potential renal involvement and potential indicators of LN, the examine included 8,631 SLE sufferers receiving care from group rheumatologists over a five-year time interval. The evaluation discovered that 62% of those SLE sufferers had ICD-10 coding or scientific laboratory measurements suggestive of LN. Of the sufferers with suspected LN, 97% had an eGFR evaluation, in comparison with 66% and 62% of sufferers who had a protein evaluation by urine check strip or urine protein, respectively. Moreover, 40% of the sufferers with suspected LN had an ICD-10 code particularly for LN, in comparison with 60% with ICD-10 codes indicating kidney circumstances, eGFR lower, or proteinuria.
“The overwhelming majority of individuals dwelling with SLE present indicators of potential kidney involvement. Nevertheless, our evaluation means that many SLE sufferers are usually not receiving correct kidney screenings, and that LN is under-recognized and under-coded. A extra proactive strategy, together with common screening for proteinuria, is essential for earlier detection and remedy of LN to attenuate irreversible kidney harm,” stated Dr. Nehad Soloman, lead examine writer and board-certified rheumatologist.
Charges of Sustained, Full Renal Response with Lengthy-Time period Use of LUPKYNIS in LN
An evaluation from the Part 3 AURORA 1 and a pair of research highlighted the long-term efficacy of LUPKYNIS in folks with LN. This examine centered on a brand new efficacy endpoint, sustained full renal response (SCRR), outlined by america Meals and Drug Administration (FDA) as attaining an entire renal response (CRR) at 12 months in AURORA 1 and in any respect examine visits within the 2-year AURORA 2 continuation examine. Considerably extra LUPKYNIS sufferers achieved SCRR in comparison with sufferers receiving placebo. The SCRR endpoint was included in an FDA-approved label replace for LUPKYNIS earlier this 12 months.
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Extra research to be introduced at ACR assessed the effectiveness of instruments geared toward measuring patient-reported outcomes utilizing knowledge from the AURORA scientific program.
Following is the whole information to Aurinia’s accepted abstracts at ACR 2024:
Title: Validity, Reliability and Responsiveness of Lupus Affect Tracker and LupusPRO: AURORA Trial
Authors: Meenakshi Jolly, Matt Truman, Ronald Flauto, Kathryn Dao
Date: Saturday, November 16, 2024
Time: 10:30 a.m. – 12:30 p.m. ET
Summary Quantity: 0661
Title: Charges of Sustained Full Renal Response with Lengthy-term Use of Voclosporin in AURORA 2
Authors: Ernie Yap, Matt Truman, Cynthia Auguste, Vanessa Birardi, Greg Keenan
Date: Sunday, November 17, 2024
Time: 10:30 a.m. – 12:30 p.m. ET
Summary Quantity: 1545
Title: Affected person Reported Outcomes Analyses from AURORA 1 Medical Trial: Lupus Affect Tracker and LupusPRO
Authors: Meenakshi Jolly, Matt Truman, Ronald Flauto, Kathryn Dao
Date: Sunday, November 17, 2024
Time: 10:30 a.m. – 12:30 p.m. ET
Summary Quantity: 1538
Title: Characterizing the Inhabitants with Suspected Lupus Nephritis in Care of a Group Rheumatology Community
Authors: Nehad Soloman, Jawad Bilal, Romy Cabacungan, Scott Milligan, Andrew Sharobeem, John Tesser, Henry Leher
Date: Monday, November 18, 2024
Time: 10:30 a.m. – 12:30 p.m. ET
Summary Quantity: 2415
About Lupus Nephritis
Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus (SLE), a power and complicated autoimmune illness. LN impacts roughly 120,000 folks within the U.S. and disproportionately impacts ladies and folks of colour. Individuals dwelling with LN have excessive unmet wants and infrequently face important boundaries to optimum care. If poorly managed, LN can result in everlasting and irreversible tissue harm throughout the kidney.
Medical tips suggest that every one SLE sufferers obtain routine LN screenings at each go to. Tips additionally be aware that delaying LN analysis has profound prognostic repercussions. But, analysis exhibits that roughly 50% of SLE sufferers are usually not screened for LN and 77% of individuals with LN go untreated. Aurinia is dedicated to bettering well being outcomes for folks dwelling with LN by educating sufferers and suppliers on the crucial want for routine screening and transformative therapies that may assist enhance well being outcomes.
About LUPKYNIS
LUPKYNIS is a second era calcineurin inhibitor (CNI) with a twin mechanism of motion, appearing as an immunosuppressant by means of inhibition of T-cell activation and cytokine manufacturing and selling podocyte stability within the kidney. The AURORA Medical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the significance of LUPKYNIS plus normal of care to protect kidney well being in sufferers with lively LN with out reliance on power high-dose glucocorticoids. It’s the solely scientific program to incorporate three years of LN remedy and follow-up with mycophenolate mofetil (MMF) and steroids.
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About Aurinia
Aurinia Prescription drugs is a totally built-in biopharmaceutical firm centered on delivering therapies to folks dwelling with autoimmune ailments with excessive unmet medical wants. In January 2021, the Firm launched LUPKYNIS® (voclosporin), the primary FDA-approved oral remedy devoted to the remedy of grownup sufferers with lively lupus nephritis. Aurinia can also be creating AUR200, a differentiated, potential best-in-class remedy for autoimmune ailments that targets each BAFF (B-cell Activating Issue) and APRIL (A Proliferation-Inducing Ligand).
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LUPKYNIS is indicated together with a background immunosuppressive remedy routine for the remedy of grownup sufferers with lively lupus nephritis (LN).
Limitations of Use: Security and efficacy of LUPKYNIS haven’t been established together with cyclophosphamide. Use of LUPKYNIS just isn’t really helpful on this scenario.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Elevated danger for creating malignancies and severe infections with LUPKYNIS or different immunosuppressants which will result in hospitalization or loss of life.
CONTRAINDICATIONS: LUPKYNIS is contraindicated in sufferers taking sturdy CYP3A4 inhibitors due to the elevated danger of acute and/or power nephrotoxicity, and in sufferers who’ve had a severe/extreme hypersensitivity response to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Different Malignancies: Immunosuppressants, together with LUPKYNIS, improve the danger of creating lymphomas and different malignancies, significantly of the pores and skin. The danger seems to be associated to rising doses and length of immunosuppression fairly than to using any particular agent.
Critical Infections: Immunosuppressants, together with LUPKYNIS, improve the danger of creating bacterial, viral, fungal, and protozoal infections, together with opportunistic infections which result in severe, together with deadly outcomes.
Nephrotoxicity: LUPKYNIS, like different calcineurin inhibitors (CNIs), could trigger acute and/or power nephrotoxicity. The danger is elevated when CNIs are concomitantly administered with medication related to nephrotoxicity. Monitor eGFR commonly.
Hypertension: Hypertension is a standard antagonistic response of LUPKYNIS remedy and should require antihypertensive remedy. Monitor blood strain commonly.
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Neurotoxicity: LUPKYNIS, like different CNIs, could trigger a spectrum of neurotoxicities: extreme embrace posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others embrace tremor, paresthesia, headache, and adjustments in psychological standing and/or motor and sensory features. Monitor for neurologic signs.
Hyperkalemia: Hyperkalemia, which can be severe and require remedy, has been reported with CNIs, together with LUPKYNIS. Concomitant use of brokers related to hyperkalemia could improve the danger for hyperkalemia. Monitor serum potassium ranges periodically.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent method when dosed greater than the really helpful lupus nephritis therapeutic dose. The usage of LUPKYNIS together with different medication which are identified to delay QTc could lead to clinically important QT prolongation.
Immunizations: Keep away from using dwell attenuated vaccines throughout remedy with LUPKYNIS. Inactivated vaccines famous to be protected for administration might not be sufficiently immunogenic throughout remedy with LUPKYNIS.
Pure Purple Cell Aplasia: Circumstances of pure purple cell aplasia (PRCA) have been reported in sufferers handled with one other CNI immunosuppressant. If PRCA is recognized, think about discontinuation of LUPKYNIS.
Drug-Drug Interactions: Keep away from co-administration of LUPKYNIS and powerful CYP3A4 inhibitors or with sturdy or average CYP3A4 inducers. Co-administration of LUPKYNIS with sturdy CYP3A4 inhibitors is contraindicated. Scale back LUPKYNIS dosage when co-administered with average CYP3A4 inhibitors. Keep away from use of LUPKYNIS with sturdy or average CYP3A4 inducers.
ADVERSE REACTIONS
The commonest antagonistic reactions (≥3%) have been glomerular filtration price decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract an infection, stomach ache higher, dyspepsia, alopecia, renal impairment, stomach ache, mouth ulceration, fatigue, tremor, acute kidney damage, and decreased urge for food.
SPECIFIC POPULATIONS
Being pregnant: Keep away from use of LUPKYNIS.
Lactation: Think about the mom’s scientific want for LUPKYNIS and any potential antagonistic results to the breastfed toddler when prescribing LUPKYNIS to a lactating girl.
Renal Impairment: LUPKYNIS just isn’t really helpful in sufferers with baseline eGFR ≤45 mL/min/1.73 m2 except profit exceeds danger. If used on this inhabitants, cut back LUPKYNIS dose.
Hepatic Impairment: For delicate or average hepatic impairment, cut back LUPKYNIS dose. Keep away from use with extreme hepatic impairment.
Please see Prescribing Info, together with Boxed Warning, and Treatment Information for LUPKYNIS.
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Contacts
Media & Investor Inquiries:
Andrea Christopher
Company Communications & Investor Relations
Aurinia Prescription drugs Inc.
achristopher@auriniapharma.com
Normal Investor Inquiries:
ir@auriniapharma.com
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