Real-World Data on Voclosporin for the Treatment of Lupus Nephritis, Including Use of Concomitant Biologic Therapies: Analysis of the Enlight-LN Registry

Background: Voclosporin is approved for the treatment of adults with active lupus nephritis (LN). In the Phase 3 AURORA studies, voclosporin plus MMF and low-dose glucocorticoids led to significant reductions in proteinuria while maintaining a stable eGFR for up to 3 years of follow-up. Biologic therapies are also frequently used in systemic lupus erythematosus and LN, yet information on the use of voclosporin in combination with these agents is limited. Here we describe baseline characteristics and demographics of patients enrolled in the Enlight-LN registry and detail the use of concomitant medications, specifically biologics. Methods: The Enlight-LN registry enrolled patients between March 2022 and January 2025 (NCT05337124). Enrolled patients were ≥18 years with biopsy-confirmed LN who initiated treatment with commercial voclosporin prior to study consent. Patients received standard of care in accordance with usual clinical practice at each site. 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%), Class IV disease (20.1%), or mixed Class IV/V disease (15.7%). Median (range) eGFR was 89.3 (6-170) mL/min/1.73 m2; 10.4% of patients had baseline eGFR <45 mL/min/1.73 m2. Median (range) UPCR was 2.3 (0.1-16.8) g/g; 38.2% of patients had baseline UPCR ≥3 g/g. There were 83 (36.2%) patients on voclosporin who concomitantly received treatment with a biologic including belimumab (28.4%), rituximab (4.8%), anifrolumab (3.9%) and obinutuzumab (1.3%). Conclusion: This initial analysis portrays the use of concomitant immunosuppressive biologics in LN patients treated with voclosporin. This is notable given the unique and possibly synergistic effects of these agents on the immune system. Additional analysis of the registry data will provide further clinical and mechanistic insights into the use of these multi-targeted therapeutic approaches. Funding: Commercial Support - Aurinia Pharmaceuticals Inc.

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