Kidney Week

Abstract: TH-PO653

Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States

Session Information

• Lupus Nephritis: Clinical, Outcomes, and Therapeutics
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Nobakht, Niloofar, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, United States

Niloofar Nobakht, MD, FASN

• Geraldino-Pardilla, Laura B., Columbia University Irving Medical Center, New York, New York, United States

Laura B. Geraldino-Pardilla, MD, MS

• Wise, Leanna Marderian, University of Southern California Keck School of Medicine, Los Angeles, California, United States

Leanna Marderian Wise, MD, MPH

• Kamgar, Mohammad, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, United States

Mohammad Kamgar, MD, FASN

• Cipolla, Lily, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada

Lily Cipolla, PharmD

• Hodge, Lucy S., Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada

Lucy S. Hodge, PharmD, PhD

• Dahl, Keelin, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada

Keelin Dahl, PharmD

Background

Voclosporin is approved for adults with active lupus nephritis (LN). In the AURORA 1 and AURORA 2 studies, adding voclosporin to MMF and low-dose glucocorticoids led to significantly earlier and greater reductions in proteinuria while maintaining stable eGFR for up to 3 years.

The Enlight-LN registry is designed to characterize the real-world effectiveness and usage patterns of voclosporin in the United States (US). We describe baseline demographics and clinical characteristics of patients currently enrolled in this ongoing, prospective, observational registry.

Methods

The registry is enrolling patients ≥18 years with biopsy-confirmed LN who are initiating or have already initiated treatment with commercial voclosporin within 12 months prior to study consent. Patients receive standard of care according to usual clinical practice. Data are extracted from patient records ~every 3 months up to 36 months and include demographics, disease characteristics, response to therapy and treatment patterns.

Results

Data are available on 123 patients enrolled prior to or on December 31, 2023. Patients ranged in age from 18 to 72 years (median, 33 years); 82.9% were female. Most patients self-identified as White (43.1%) or Black/African American (35.8%); 7.3% were Asian. A total of 35.8% were Hispanic/Latino. Median (range) time since first LN diagnosis was 1.1 (0-26.2) years. The majority of patients (62.6%) had Class III or IV +/- V disease; 32.5% had Class V disease. Median (range) eGFR and SCr were 90 (20-143) mL/min/1.73 m² and 0.9 (0-66) mg/dL, respectively. Median (range) UPCR was 2.0 (0-16.8) g/g. A total of 107 patients were on concomitant immunosuppression at voclosporin initiation (most commonly, antimalarials, 72.4%; MMF/mycophenolate sodium, 70.7%; belimumab, 13%). In addition, 58.5% of patients were on steroids and 40.7% on RAAS agents. Three patients were on SGLT-2 inhibitors.

Conclusion

Baseline data on this initial cohort of patients are reflective of the larger LN population in the US, including high percentages of Black and Hispanic and/or Latino patients. Enrollment of additional patients and ongoing data collection will provide valuable insight into the real-world utilization of voclosporin.

Funding

• Commercial Support – Aurinia Pharmaceuticals Inc.