Study: Long-Term Data on LUPKYNIS for Lupus Nephritis

Aurinia Pharmaceuticals Inc. plans to release the updated results from their continuation study of AURORA 2. This clinical trial is evaluating LUPKYNIS, also known as voclosporin, as a treatment for lupus nephritis (LN). It specifically focused on the long-term safety and tolerability of this calcineurin inhibitor (CNI).

About Lupus Nephritis

First, let’s dive into what lupus nephritis is. Lupus nephritis is a common complication of lupus. In fact, 40% of lupus patients go on to develop LN. In this condition, antibodies attack the part of the kidneys that filter out waste, causing proteinuria, inflammation, hematuria, high blood pressure, and kidney failure in extreme cases. Females and those of African and Asian descent are at a higher risk of developing lupus.

Symptoms specific to lupus nephritis include pain and swelling in the joints, dark and foamy urine, edema, high blood pressure, muscle pain, fever, and rash. The cause is unknown, although medical professionals suspect that it is a combination of genetic and environmental factors. Various lab tests, including urine tests, blood tests, and kidney biopsy, are used to diagnose this condition. Treatment aims to decrease inflammation, reduce high blood pressure, and suppress the immune system.

LUPKYNIS for LN

LUPKYNIS is an oral, structurally modified calcineurin inhibitor (CNI) for the treatment of LN. It promotes the stability of podocytes in the kidney, alongside obstructing the production of cytokines and inhibiting T-cell activation.

It is currently being studied in a continuation of the AURORA 2 clinical trial, where researchers are focusing on the long-term tolerability and safety. This trial is double-blind, randomized, and placebo-controlled composed of 216 patients who finished the Phase 3 AURORA 1 trial (this trial’s results were recently published).

These patients opted to take LUPKYNIS in addition to the current standard of care, mycophenolate mofetil (MMF), for 24 months. Results will be presented next week at The American College of Rheumatology (ACR) Convergence 2021. For now, we know that:

  • Patients treated with LUPKYNIS maintained significant reductions in proteinuria
  • Stable estimated glomerular filtration rate (eGFR) in the LUPKYNIS group
  • Mean urine protein/creatine levels were -3.32 mg/mg in patients receiving LUPKYNIS
    • This can be compared to -2.55 mg/mg in the placebo group
  • No new or unexpected adverse events

You can read more about this study here.

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