Abstract: INFO16-FR
Enlight-LN™: Registry of US Adult Patients Treated with Lupkynis™ (Voclosporin) for Lupus Nephritis
Session Information
- Informational Posters - II
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Cipolla, Lily, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Bal, Victoria, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
- Leher, Henry, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
Description
Voclosporin is approved for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy in the United States. The Phase 3 AURORA 1 study found that adding voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids led to earlier reductions in proteinuria across biopsy classes, races, and ethnicities, with long-term safety demonstrated over three years in patients who continued treatment in the AURORA 2 study.
Here we describe an actively enrolling prospective observational registry, designed to characterize the real-world effectiveness and utilization patterns of voclosporin in the United States.
Patients enrolled in Enlight-LN receive standard care in accordance with clinical practice at each site, with no mandatory visits or assessments required by the protocol. Data are extracted from patient medical records for up to 36 months of follow-up. Demographics, disease characteristics, response to therapy, and treatment patterns and utilization will be analyzed. The registry is enrolling patients in the United States who are initiating or who have already initiated treatment with commercial voclosporin within three months prior to study consent. Patients ≥18 years of age with biopsy-confirmed lupus nephritis are eligible.
To date, there are 58 study sites across the United States participating in the registry. There are an equal number of sites (n=15) in both the Southwest and Northeast, with seventeen, nine, and two sites in the Southeast, Midwest, and Northwest, respectively. Private practices make up 69% of the sites, while the remaining sites are academic centers. Thirty-three sites specialize in rheumatology, twenty-three sites in nephrology, and one site in internal medicine.
The study is actively enrolling patients (NCT05337124).
Funding
- Aurinia Pharmaceuticals Inc. has provided the funding for this registry.