Aurinia Commends 2024 Updated ACR Guidelines for Screening, Treatment, and Management of Lupus Nephritis

In This Article:

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, November 18, 2024--(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.

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