Early on in 2021, the FDA approved voclosporin as an add-on treatment for patients with lupus nephritis (LN), a frequent complication of lupus. Ultimately, this approval was a positive decision, especially as new clinical trial results highlight the therapy’s efficacy. According to Medicine Matters, Phase 3 clinical trial data shows that voclosporin, in conjunction with other immunosuppressants, improves renal response rates in patients with LN. See the full study findings published in The Lancet.

Voclosporin

Developed by Aurinia Pharmaceuticals, voclosporin, marketed under the name LUPKYNIS, is described by DrugBank as:

a calcineurin-inhibitor immunosuppressant [and cyclosporine A analog] for the treatment of LN. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN.

The recent clinical trial data was sourced from the Phase 3 AURORA 1 trial. Altogether, 357 patients enrolled in the trial. All patients were diagnosed with lupus and had active class II, IV, or IV LN. During the trial, 179 patients received add-on voclosporin (23.7mg 2x daily) in conjunction with their current immunosuppressive therapy (1g mycophenolate mofetil 2x daily; 0.25-05g intravenous methylprednisolone; 20-25mg prednisone tapering). The remaining patients received a placebo on top of that therapy. Researchers determined that:

• Patients receiving voclosporin saw significantly higher renal response rates than those receiving the placebo (41% vs. 23%).
• Ultimately, voclosporin helped to rapidly reduce proteinuria within 1 year of treatment. Proteinuria is defined as excess protein in the urine. In patients receiving voclosporin, they reduced proteinuria by 50% within 29 days, compared to 63 days in those receiving a placebo.
• Although the treatment was relatively safe, side effects did occur in 91% of those receiving voclosporin. Serious reactions occurred in around 21% of treated patients, regardless of what group they were in.
• The most common adverse reactions were infections.

Lupus Nephritis (LN)

As described above, lupus nephritis (LN) is a kidney infection that occurs as a complication in patients with lupus. An estimated 60% of patients with lupus will eventually develop LN. Typically, children with lupus are more likely to develop LN, although around half of all adults with lupus will as well. Doctors are not sure why it occurs in some patients and not others. However, genetics and environmental factors are thought to play a role. Additionally, LN is more common in women and those of African or Asian descent.

In lupus, the body creates autoantibodies which mistakenly attack parts of the kidney that filter out waste. As the kidney becomes more inflamed, renal function falls. Without treatment, this can ultimately lead to kidney failure. Symptoms vary but include:

• Proteinuria (high levels of protein in the urine)
• Joint and muscle pain
• Fever (with no known cause)
• Swelling of the feet, legs, and ankles
• Unintended weight gain
• Increased need to urinate
• High blood pressure
• Dark and/or foamy urine
• Joint inflammation and/or restricted motion
• Red butterfly-shaped rash on the face