Background/Purpose: The 2024 American College of Rheumatology Lupus Nephritis (LN) Guideline recommends triple immunosuppressive therapy, including the option of a calcineurin inhibitor (CNI)-based regimen, for patients with active lupus nephritis (LN). Voclosporin is a second generation CNI approved for adults with active LN. During clinical trials, voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, led to significant reductions in proteinuria with stable estimated glomerular filtration rate (eGFR) with up to 3 years of exposure compared to MMF and glucocorticoids alone. The Enlight-LN registry was designed to characterize the real-world effectiveness and usage patterns of voclosporin in the United States. Here we describe the initial outcomes of patients who participated in this registry.

Methods: The Enlight-LN registry enrolled patients between March 2022 and January 2025 (NCT05337124). Patients were ≥18 years with biopsy-confirmed LN who initiated or had already initiated treatment with commercial voclosporin prior to study consent. Patients received standard of care in accordance with usual clinical practice at each site. Mandatory assessments included renal parameters and blood pressure. Data were extracted from patient records approximately every 3 months. Safety data were collected via spontaneous reporting.

Results: As of April 4, 2025, data were available on 229 patients. Median (range) patient age was 34.0 (18-78), with 36.2% of patients ≤30 years; 83.4% were female. Most patients self-identified as White (43.2%) or Black/African American (38.0%); 35.4% were Hispanic/Latino. Median (range) time since first LN diagnosis was 1.6 (0, 26.2) years. The majority of patients had Class V disease (31.4%) or Class IV disease (20.1%). Median (range) UPCR decreased from 2.3 (0.1-16.8) g/g at baseline (n=191) to 0.9 (0.1-18.7) g/g at month 6 (n=89). Median (range) corrected eGFR was 89.3 (6-90) mL/min/1.73 m2 at baseline (n=222) and 82.0 (3-90) mL/min/1.73 m2 at month 6 (n=120). Safety data collected during the registry appears to be consistent with the established safety profile of voclosporin.

Conclusion: Patients in the Enlight-LN registry reflect the larger LN population in the US, including high percentages of Black and Hispanic and/or Latino patients. The outcomes data from this initial analysis are consistent with the findings from the voclosporin clinical trials, with substantial reductions in proteinuria observed over the first few months of treatment, with no new safety signals. These real-world data support the recent updates to the ACR guidelines recommending use of triple immunosuppressive therapy first-line in patients with active LN.

« Back to ACR Convergence 2025

ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-effectiveness-and-usage-of-voclosporin-data-from-the-enlight-ln-registry/