New AURORA 1 analysis: Lupkynis-based triple immunosuppressive therapy yields deep proteinuria reduction in lupus nephritis- Aurinia Pharma

Aurinia Pharmaceuticals Inc.  announced that a post-hoc analysis of the 52-week, Phase III AURORA 1 study presented at at LUPUS 2025, the 16^th International Congress on SLE, showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with Lupkynis (voclosporin), mycophenolate mofetil (MMF) and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone.

The analysis assessed the achievement of urine protein creatine ratio (UPCR) targets of ≤0.4 g/g, ≤0.3 g/g, ≤0.2 g/g (classified as ultra-low UPCR), and ≤0.1 g/g in LN patients treated with Lupkynis-based triple immunosuppressive therapy compared to patients in the control group. Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). Patients in the triple immunosuppressive therapy group also achieved higher rates of all other UPCR targets compared to patients in the control group. Adverse event rates were comparable in both groups.

An additional post-hoc analysis from the AURORA 1 study evaluated lipidomic profiles in LN patients based on achievement of proteinuria reductions, including ultra-low UPCR, at Week 52. The analysis found a distinct lipidomic profile in patients who achieved ultra-low UPCR. This analysis builds upon a previous analysis of AURORA 1 in which patients who received triple immunosuppressive therapy with LUPKYNIS achieved significantly greater improvements in total and low-density lipoprotein (LDL) cholesterol compared to those in the control group. While further research is needed to clarify the role of certain lipids in the biochemistry of LN patients, these preliminary findings suggest that attaining ultra-low UPCR targets may provide additional benefits to LN patients and contribute to modification of cardiovascular disease risk.

Details are as follows Title: Achievement of Proteinuria Less Than 0.4 G/G in the Phase 3 AURORA 1 Study of Voclosporin in Lupus Nephritis 
Authors: Maria Dall'Era, Brad Rovin et al.
Date: Thursday, May 22 
Abstract Number: 232

An analysis of real-world baseline data from ENLIGHT-LN, a U.S.-based prospective, observational registry of adult LN patients treated with LUPKYNIS, was also presented at LUPUS 2025. Details are as follows Title: Baseline Demographics, Clinical Characteristics, and Treatment Regimens of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry 
Authors: Laura Geraldino-Pardilla, Leanna Wise et al. 
Poster Session: Lupus Nephritis-Clinical 
Date: On display for duration of meeting 
Abstract Number: 249

“It is widely known that no level of proteinuria is safe for nephrons and that early reductions in proteinuria are predictive of better long-term kidney outcomes. Yet, UPCR endpoints have varied widely across clinical trials and in clinical practice,” said lead study author Prof. Maria Dall’Era,  Division of Rheumatology, University of California, San Francisco. “This analysis shows that achieving UPCR targets of ≤0.4 g/g may be a feasible goal and that a voclosporin-based triple immunosuppressive therapy regimen can reduce proteinuria to profoundly low levels in a proportion of patients.”

 “The data presented at LUPUS 2025 highlight the critical role of LUPKYNIS in improving health outcomes for LN patients. Early reduction of proteinuria to the lowest possible levels and long-term preservation of kidney health are key goals of LN therapy. These data provide compelling evidence that LUPKYNIS-based therapy can achieve significantly lower UPCR targets, potentially reducing the risk of significant kidney damage and other comorbidities,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.