Long-Term Data, Renal Function Monitoring Update Added to Lupkynis Labeling – Renal and Urology News

The prescribing information for Lupkynis^™ (voclosporin) has been updated to include long-term data from the AURORA 2 study.

Lupkynis is a calcineurin inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis. It was approved in 2021 based on data from the phase 3 AURORA 1 study (ClinicalTrials.gov Identifier: NCT03021499).

The updated label now includes 3-year data from AURORA 2 (ClinicalTrials.gov Identifier: NCT03597464), a double-blind, placebo-controlled extension study. The trial assessed the long term safety and tolerability of voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, vs MMF and low-dose glucocorticoids alone, in adults with active lupus nephritis who completed the AURORA 1 clinical trial.

Results from AURORA 2 showed 36 of the 179 voclosporin-treated patients and 21 of the 178 placebo-treated patients achieved sustained complete renal response (defined as achieving renal response at month 12 of AURORA 1 and maintaining the renal response at each subsequent study visit through month 36). It was noted that 21.8% (n=39) and 23% (n=41) of voclosporin and placebo patients, respectively, had missing data at the end of the first year or by the end of the 2-year extension study and had unknown status for sustained complete renal response. 

“Data from our AURORA 2 extension study included in the Lupkynis label showed a maintenance of sustained complete renal response with Lupkynis in combination with MMF and low-dose glucocorticoids, at every time point assessed through 3 years, relative to MMF and low-dose glucocorticoids alone,” said Dr Greg Keenan, Chief Medical Officer of Aurinia. “This notable outcome is aligned with treatment guidelines calling for use of Lupkynis for at least 3 years to reduce proteinuria.”

The labeling also includes new guidance for monitoring renal function in patients taking Lupkynis. Estimated glomerular filtration rate (eGFR) should be assessed every 2 weeks for the first month, every 4 weeks through the first year and quarterly thereafter. “[…] guidance on monitoring kidney function quarterly after the first year of Lupkynis treatment reflects the reality of clinical practice,” added Dr Keenan.

Additionally, the updated label provides more data regarding the transfer of Lupkynis to breast milk. The prescribing information states that at steady state following a maternal twice daily dosing regimen, the percent of voclosporin dose present in breast milk is expected to be similar to that following a maternal single dose.

This article originally appeared on MPR