Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) commended the American College of Rheumatology (ACR) for its newly released 2024 evidence-based guidelines on the screening, treatment, and management of lupus nephritis (LN). The updated guidelines emphasize the urgent need for effective treatments to prevent nephron loss and preserve kidney function in LN patients.
The guidelines recommend a triple immunosuppressive treatment regimen for LN, with first-line use of advanced therapies like LUPKYNIS for up to five years. A key recommendation is to taper steroids to a maintenance dose of less than 5 mg/day by six months. The guidelines also set a target of achieving a urine protein-to-creatinine ratio (UPCR) of less than 0.5 g/g by 12 months of treatment.
LUPKYNIS, a calcineurin inhibitor (CNI) approved by the FDA for the treatment of adult patients with active LN, was highlighted in the guidelines based on data from the AURORA Clinical Program, including the Phase 3 AURORA 1 study. In AURORA 1, patients on LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids were 81% more likely to achieve a complete renal response at 52 weeks (40.8% vs. 22.5%) compared to those on MMF and glucocorticoids alone. More than 80% of patients in the trial were able to reduce steroid use to below 2.5 mg/day by 16 weeks, surpassing the new guideline’s target for steroid tapering.
LUPKYNIS is the only FDA-approved CNI for active LN and has shown broad clinical benefits across diverse patient populations, including various biopsy classes, eGFR ranges, and demographics.
The updated guidelines also call for routine urine screening for proteinuria in patients with systemic lupus erythematosus (SLE) who have no known kidney disease or experience extra-renal flares. Additionally, a kidney biopsy is recommended for patients with elevated urine protein levels (>0.5 g/g) or unexplained kidney dysfunction.
“We applaud the ACR’s comprehensive and timely guidelines, which offer crucial guidance for early diagnosis and effective treatment of lupus nephritis. These guidelines reinforce the importance of initiating triple immunosuppression therapy with medications like LUPKYNIS to help achieve complete renal responses and preserve kidney function in patients,” said Dr. Greg Keenan, Chief Medical Officer at Aurinia.
The ACR’s 2024 guidelines are based on systematic evidence reviews and input from rheumatologists, nephrologists, and individuals living with lupus nephritis.
About LUPKYNIS
LUPKYNIS is a novel calcineurin inhibitor (CNI) with a dual mechanism of action, helping to suppress T-cell activation and promoting kidney podocyte stability. The AURORA Clinical Program, which included the AURORA 1 pivotal trial and the AURORA 2 extension trial, demonstrated that LUPKYNIS, in combination with standard treatments, is effective in preserving kidney function in LN patients while reducing the need for long-term high-dose steroids.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company dedicated to developing therapies for autoimmune diseases with high unmet medical needs. The company’s lead product, LUPKYNIS® (voclosporin), is the first FDA-approved oral therapy for adult patients with active lupus nephritis. Aurinia is also advancing AUR200, a promising new therapy for autoimmune diseases targeting both BAFF and APRIL.
