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Aurinia Pharmaceuticals (NASDAQ: AUPH) welcomes the American College of Rheumatology’s (ACR) 2024 guidelines for lupus nephritis (LN) treatment. The new guidelines recommend LUPKYNIS as first-line therapy in a triple immunosuppressive treatment regimen. Key highlights include steroid tapering to <5 mg/day by six months and achieving proteinuria target of <0.5g/g UPCR by 12 months. The AURORA 1 clinical study showed patients were 81% more likely to achieve complete renal response at 52 weeks with LUPKYNIS combination therapy versus standard treatment. Notably, >80% of patients reached steroid doses of <2.5mg/day by 16 weeks.
Aurinia Pharmaceuticals (NASDAQ: AUPH) accoglie con favore le linee guida 2024 dell’American College of Rheumatology (ACR) per il trattamento del lupus nefritico (LN). Le nuove linee guida raccomandano LUPKYNIS come terapia di prima linea in un regime di trattamento immunosoppressivo triplo. Tra i punti salienti, si evidenzia la riduzione degli steroidi a <5 mg/giorno entro sei mesi e il raggiungimento di un obiettivo di proteinuria <0.5g/g UPCR entro dodici mesi. Lo studio clinico AURORA 1 ha dimostrato che i pazienti avevano l’81% di probabilità in più di raggiungere una risposta renale completa a 52 settimane con la terapia combinata LUPKYNIS rispetto al trattamento standard. È notevole che oltre l’80% dei pazienti abbia raggiunto dosi di steroidi di <2.5mg/giorno entro 16 settimane.
Aurinia Pharmaceuticals (NASDAQ: AUPH) celebra las nuevas guías 2024 del American College of Rheumatology (ACR) para el tratamiento de lupus nefritico (LN). Las nuevas directrices recomiendan LUPKYNIS como terapia de primera línea en un régimen de tratamiento inmunosupresor triple. Entre los puntos destacados se incluye la reducción de los esteroides a <5 mg/día en seis meses y alcanzar un objetivo de proteinuria de <0.5g/g UPCR en 12 meses. El estudio clínico AURORA 1 mostró que los pacientes tenían un 81% más de probabilidad de alcanzar una respuesta renal completa a las 52 semanas con la terapia combinada de LUPKYNIS en comparación con el tratamiento estándar. Es notable que más del 80% de los pacientes alcanzaron dosis de esteroides de <2.5mg/día en 16 semanas.
Aurinia Pharmaceuticals (NASDAQ: AUPH)는 미국 류마티스학회(ACR)의 루푸스 신염 (LN) 치료에 대한 2024년 가이드라인을 환영합니다. 새로운 가이드라인은 세 가지 면역억제 치료 요법에서 LUPKYNIS를 1차 치료제로 권장합니다. 주요 사항으로는 6개월 이내에 스테로이드를 <5 mg/일로 줄이고, 12개월 이내에 단백뇨 목표인 <0.5g/g UPCR을 달성하는 것이 포함됩니다. AURORA 1 임상 연구에서는 LUPKYNIS 복합 요법을 통해 표준 치료와 비교해 52주 만에 완전한 신장 반응을 보일 확률이 81% 더 높았던 것으로 나타났습니다. 특히, 16주 이내에 스테로이드 복용량이 <2.5mg/일에 도달한 환자가 80% 이상에 달했습니다.
Aurinia Pharmaceuticals (NASDAQ: AUPH) se félicite des nouvelles recommandations 2024 du American College of Rheumatology (ACR) pour le traitement de lupus néphritique (LN). Les nouvelles directives recommandent LUPKYNIS comme thérapie de première ligne dans un schéma de traitement immunosuppresseur triple. Parmi les points clés, on trouve la réduction progressive des stéroïdes à <5 mg/jour d’ici six mois et l’atteinte d’un objectif de protéinurie de <0.5g/g UPCR d’ici douze mois. L’étude clinique AURORA 1 a montré que les patients avaient 81 % de chances en plus d’atteindre une réponse rénale complète à 52 semaines avec la thérapie combinée LUPKYNIS par rapport au traitement standard. Notamment, plus de 80 % des patients ont atteint des doses de stéroïdes de <2.5mg/jour en 16 semaines.
Aurinia Pharmaceuticals (NASDAQ: AUPH) begrüßt die neuen Richtlinien 2024 des American College of Rheumatology (ACR) zur Behandlung von Lupusnephritis (LN). Die neuen Richtlinien empfehlen LUPKYNIS als Erstlinientherapie in einem dreifach immunmodulierenden Behandlungsschema. Zu den wichtigsten Punkten gehört eine Dosisreduktion von Steroiden auf <5 mg/Tag innerhalb von sechs Monaten und das Erreichen des Proteinurie-Ziels von <0.5g/g UPCR innerhalb von zwölf Monaten. Die klinische Studie AURORA 1 zeigte, dass Patienten mit der LUPKYNIS-Kombinationstherapie 81 % wahrscheinlicher eine vollständige Nierenantwort nach 52 Wochen erreichen konnten als mit der Standardbehandlung. Besonders bemerkenswert ist, dass über 80 % der Patienten innerhalb von 16 Wochen Steroiddosen von <2.5mg/Tag erreichten.
Positive
- LUPKYNIS recommended as first-line therapy in ACR’s 2024 guidelines
- Clinical data shows 81% higher likelihood of complete renal response at 52 weeks
- Achieved superior steroid reduction (<2.5mg/day) compared to new guideline targets
- Demonstrated broad clinical utility across various patient demographics and conditions
Insights
The updated ACR guidelines represent a significant validation for LUPKYNIS’s clinical value in lupus nephritis treatment. The recommendation for triple immunosuppression with first-line use of LUPKYNIS could substantially expand its market penetration. Key clinical advantages highlighted include:
- Superior efficacy with 81% higher likelihood of complete renal response
- Successful steroid tapering to <2.5mg/day in 80% of patients by 16 weeks
- Broad clinical utility across various patient subgroups
These guidelines should drive increased adoption among rheumatologists and nephrologists, potentially accelerating LUPKYNIS’s revenue growth. The emphasis on early diagnosis and treatment initiation could also expand the addressable patient population.
New Guidelines Presented at ACR Convergence 2024 Recommend First-Line Therapy with LUPKYNIS® (voclosporin) as Part of a Triple Immunosuppressive LN Treatment Regimen
ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) commends the American College of Rheumatology (ACR) for their 2024 evidence-based guidelines for the screening, treatment, and management of lupus nephritis (LN), which prioritize the urgent need to use efficacious treatments to avoid nephron loss and preserve kidney function.
The guidelines call for a triple immunosuppression treatment regimen for LN, with first line use of advanced therapies like LUPKYNIS for three to five years. Importantly, the guidelines suggest that steroids should be rapidly tapered to <5 mg/day by six months as the highest acceptable maintenance dose of steroids. The guidelines also call for achieving a proteinuria target of <0.5g/g urine protein creatinine ratio (UPCR) by 12 months of treatment.
The recommendations included within the guidelines for use of LUPKYNIS to treat LN were based on the AURORA Clinical Program, including the Phase 3 AURORA 1 clinical study. In AURORA 1, patients were 81% more likely to achieve a complete renal response1 at 52 weeks (40.8 vs 22.5 – OR 2.7) with LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone. Additionally, > 80% of patients were tapered to a steroid dose of <2.5mg / day by 16 weeks per the AURORA protocol, making LUPKYNIS the only therapy to meet and exceed the new guideline steroid target of <5mg /day by 6 months in randomized clinical trials.
LUPKYNIS, the only FDA-approved CNI therapy for the treatment of adult patients with active LN in combination with other immunosuppressive therapies, has demonstrated broad clinical utility across biopsy class, baseline eGFR, proteinuria range, race, ethnicity, age, and gender. Please see Indication and Important Safey Information, including Boxed Warning, below.
The guidelines recommend routine urine screening for proteinuria at least every six to 12 months in patients with SLE without known kidney disease, or when experiencing extra-renal flares. They also conditionally recommend performing a kidney biopsy in patients with SLE who have high levels of protein in the urine (> 0.5 g/g) and/or impaired kidney function not otherwise explained.
“We applaud ACR’s critical and timely guidelines to improve the management of lupus nephritis for this underserved patient population. They provide clear guidance for the importance of early diagnosis and starting with triple immunosuppression therapy with CNIs like LUPKYNIS to help achieve a complete renal response and aid in preserving kidney function for adults living with lupus nephritis,” said Dr. Greg Keenan, Chief Medical Officer at Aurinia.
The updated ACR guidelines for the diagnosis and treatment of LN are based on systematic evidence reviews, feedback from a panel of people living with LN, and input from rheumatologists and nephrologists.
About LUPKYNIS
LUPKYNIS is a novel, structurally modified 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 Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. 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. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
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 lupus nephritis (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 which lead to serious, including fatal outcomes.
Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), 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 with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels 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 (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
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.
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, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
SPECIFIC POPULATIONS
Pregnancy: Avoid use of LUPKYNIS.
Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman.
Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 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
- 2024 American College of Rheumatology (ACR) Guideline for the Screening, Treatment, and Management of Lupus Nephritis. Presented November 18, 2024. Complete summary available at: https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blt4db6d0b451e88caf/lupus-nephritis-guideline-summary-2024.pdf
- Rovin B et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080. doi: 10.1016/S0140-6736(21)00578-X. Epub 2021 May 7.
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1 In the AURORA clinical program, complete renal response is defined as UPCR of 0.5 mg/mg or less, along with other criteria: stable renal function, defined as an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2, or no more than a 20% decrease from baseline in eGFR; no rescue medication; no more than 10 mg prednisone equivalent per day for at least 3 consecutive days, or 7 or more days between weeks 44 and 52.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241118903839/en/
Media & Investor Inquiries:
Andrea Christopher
Corporate Communications & Investor Relations
Aurinia Pharmaceuticals Inc.
achristopher@auriniapharma.com
General Investor Inquiries:
Source: Aurinia Pharmaceuticals Inc.
FAQ
What are the key recommendations in ACR’s 2024 lupus nephritis guidelines for AUPH’s LUPKYNIS?
The 2024 ACR guidelines recommend LUPKYNIS as first-line therapy in a triple immunosuppressive treatment regimen, with steroid tapering to <5 mg/day by six months and achieving proteinuria target of <0.5g/g UPCR by 12 months.
What were the clinical results for AUPH’s LUPKYNIS in the AURORA 1 study?
In the AURORA 1 study, patients using LUPKYNIS combination therapy were 81% more likely to achieve complete renal response at 52 weeks compared to standard treatment, with >80% of patients reaching steroid doses of <2.5mg/day by 16 weeks.
What screening recommendations does the 2024 ACR guideline include for lupus nephritis patients using AUPH’s treatments?
The guidelines recommend routine urine screening for proteinuria every six to 12 months in SLE patients without known kidney disease, and kidney biopsy for patients with protein levels >0.5 g/g or unexplained impaired kidney function.
