New guidelines presented at the 2024 American College of Rheumatology (ACR) Convergence address the critical need for effective lupus nephritis (LN) treatments. The guidelines emphasize the urgency of preserving kidney function by minimizing nephron loss. A key recommendation is adopting a triple immunosuppression regimen as first-line therapy for LN. This regimen should include advanced therapies like LUPKYNIS (voclosporin) for three to five years. Significantly, the guidelines advise a rapid steroid taper, aiming for a maintenance dose of less than 5 mg/day within six months.
A target proteinuria level of <0.5g/g urine protein creatinine ratio (UPCR) is also recommended to be achieved by 12 months. The guidelines’ recommendations for LUPKYNIS are based on the AURORA Clinical Program, notably the Phase 3 AURORA 1 study. This study demonstrated that patients receiving LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids were 81% more likely to achieve a complete renal response at 52 weeks compared to those receiving MMF and low-dose glucocorticoids alone. The complete renal response was defined as a UPCR of 0.5 mg/mg or less, stable renal function, no rescue medication, and a low prednisone equivalent dose. Furthermore, over 80% of patients in the AURORA study achieved a <2.5mg/day steroid dose by 16 weeks, highlighting LUPKYNIS’s alignment with the new steroid guidelines. LUPKYNIS is currently the only FDA-approved calcineurin inhibitor (CNI) for active LN in combination with other immunosuppressants.
Its clinical utility has been demonstrated across diverse patient demographics and disease characteristics. The guidelines also recommend regular urine screening for proteinuria in systemic lupus erythematosus (SLE) patients, even those without known kidney disease, at least every six to twelve months or during extra-renal flares. A kidney biopsy is conditionally recommended for SLE patients presenting with high urine protein levels (> 0.5 g/g) or unexplained impaired kidney function. The updated ACR guidelines for LN diagnosis and treatment are based on systematic evidence reviews, patient feedback, and expert input from rheumatologists and nephrologists.
LUPKYNIS is a novel CNI with a dual mechanism of action. It acts as an immunosuppressant by inhibiting T-cell activation and cytokine production while promoting podocyte stability within the kidney. The AURORA Clinical Program, consisting of the AURORA 1 and AURORA 2 trials, highlighted the importance of LUPKYNIS in preserving kidney health in active LN patients without relying on chronic high-dose glucocorticoids. This program stands out as the only one to include three years of LN treatment and follow-up with MMF and steroids. Aurinia Pharmaceuticals, the developer of LUPKYNIS, focuses on providing therapies for autoimmune diseases with high unmet needs. In addition to LUPKYNIS, Aurinia is developing AUR200, a potential best-in-class therapy targeting BAFF and APRIL for autoimmune diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
