Repeat Biopsy Analysis Underlines Safety, Efficacy of Voclosporin in Lupus Nephritis

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An analysis of data from 26 patients with repeat kidney biopsies in the AURORA program suggests voclosporin (Lupkynis) reduces proteinuria without causing harm in lupus nephritis patients.

An analysis of data from patients with repeat kidney biopsies from the AURORA 2 trial is providing insight into the effects of voclosporin (Lupkynis) on disease activity and chronic injury in patients with lupus nephritis.

Results of the study, which was 1 of 9 studies related to voclosporin at the American Society of Nephrology Kidney Week 2023, suggest exposure to voclosporin was associated with greater reductions in urine protein-to-creatinine ratio (UPCR) over 3 years of treatment and was not associated with chronic injury.1

“These findings from a small subset of patients further strengthen the overall evidence supporting the long-term safety of LUPKYNIS in [lupus nephritis] patients. The addition of LUPKYNIS to [mycophenolate mofetil] and low-dose glucocorticoids to treat [lupus nephritis] can lead to significantly earlier and greater reductions in proteinuria while allowing patients to maintain stable renal function,” said lead investigator Samir V. Parikh, MD, nephrologist at the Ohio State University Wexner Medical Center.2 “This is a critical aspect to consider for patients with [lupus nephritis], as proteinuria is associated with a major decline in kidney function and, in some cases, kidney failure. This increased understanding of the long-term safety and efficacy profile of LUPKYNIS will contribute to improving outcomes over time for this patient population.”

Voclosporin became the first oral therapy to be granted an indication for treatment of lupus nephritis when the US Food and Drug Administration awarded the approval to Aurinia Pharmaceuticals in January 2021. The approval was based on data from the AURORA program, which demonstrated the addition of voclosporin to standard of care was associated with a more than doubling in the likelihood of achieving renal response and experienced a decline in UPCR twice as fast as patients on typical standard of care alone.3

In the current analysis, investigators assessed data from a subset of patients who had a kidney biopsy prior to screening and a repeat biopsy after approximately 18 months of therapy from within the pivotal AURORA program. A total of 26 patients were identified for inclusion in the analyses, with 16 from the program’s voclosporin arm and 10 from the control arm.1

Initial analysis of patient characteristics for the 26-patient cohort indicated mean activity scores were similar between the voclosporin and both arms ( and improved throughout the study period. Further analysis indicated mean chronicity scores were also similar between the voclosporin and control arms (3.8 [SD, 3.5] vs. 2.9 [SD, 2.3]) and this remained stable over time in most patients (4.1 [SD, 3.3] vs. 2.8 [SD, 2.7]).1

Analysis suggested mean eGFR remained stable in both the voclosporin (baseline: 80.3 [SD, 16.4]; month 36: 82.7 [SD, 15.4]) and control arms baseline: 82.6 [SD, 12.3]; month 36: 85.8 [SD, 13.3]) over the 3-year follow-up. Investigators also highlighted voclosporin-treated patients had numerically greater mean reductions from baseline in UPCR year-on-year compared to patients in the control arm.1

“These data contribute to our growing body of evidence that LUPKYNIS enables positive long-term kidney outcomes for people living with [lupus nephritis], a debilitating, yet common complication that occurs in about half of people with lupus,” said Greg Keenan, chief medical officer of Aurinia.2 “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNIS treatment."

References:

  1. Parikh SV, Abner C, Yap E, Piper K, Huizinga R, Leher H. Repeat kidney biopsies from the AURORA 2 study of voclosporin in active lupus nephritis. Paper Presented at: American Society of Nephrology Kidney Week 2023. November 1-5, 2023.
  2. Aurinia Pharmaceuticals Inc. Aurinia presents breadth of data at ASN 2023 demonstrating clinical importance of LUPKYNISⓇ for managing lupus nephritis. Aurinia Pharmaceuticals Inc. November 2, 2023. Accessed November 5, 2023. https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/308/aurinia-presents-breadth-of-data-at-asn-2023-demonstrating.
  3. Aurinia Pharmaceuticals Inc. FDA approves Aurinia Pharmaceuticals’ LUPKYNISTM (voclosporin) for adult patients with active lupus nephritis. Aurinia Pharmaceuticals Inc. January 22, 2021. Accessed November 5, 2023. https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis.

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