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Abstract: SA-PO877

Comparison of Dual-Immunosuppressive Therapy and a Voclosporin-Based, Triple-Immunosuppressive Regimen for Lupus Nephritis: A Propensity Analysis of ALMS and AURORA 1

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Yap, Ernie, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
  • Dall'Era, Maria, University of California San Francisco School of Medicine, San Francisco, California, United States
  • Truman, Matt, Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
  • Hodge, Lucy S., Aurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada
  • Solomons, Neil, Neil Solomons Consulting Inc., Victoria, British Columbia, Canada
Background

To understand the safety and efficacy of a voclosporin-based, MMF and glucocorticoid-sparing, triple immunosuppressive regimen as an initial approach to therapy in active lupus nephritis (LN) compared to conventional high-dose MMF and glucocorticoid regimens, we compared and analyzed clinical data in propensity-matched patients from ALMS and AURORA 1. We hypothesized that a voclosporin-based, triple immunotherapy approach would reduce exposure to toxicities associated with glucocorticoids and MMF, resulting in an improved safety profile without compromising efficacy.

Methods

Both studies enrolled participants with active LN. In ALMS, MMF was dosed to a target of 3 g/day with oral glucocorticoids initiated at a maximum dose of 60 mg/day and tapered every 2 weeks to 10 mg/day. In AURORA 1, participants received voclosporin 23.7 mg BID in combination with MMF at a target dose 2 g/day and oral glucocorticoids started at 25 mg/day and tapered to 2.5 mg/day by Week 16. Propensity matching generated 2 groups of matched patients based on demographic and disease characteristics. Safety and efficacy outcomes were assessed at 3 and 6 months.

Results

Propensity matching identified 96 pairs of participants with similar demographics and baseline disease characteristics. At 3 and 6 months, MMF and glucocorticoid exposure was more than 2-fold higher in ALMS than AURORA 1. Overall, fewer adverse events (AE) were observed in AURORA 1 across the majority of organ systems, including gastrointestinal, skin and subcutaneous tissues, endocrine, and psychiatric disorders, although more patients in AURORA 1 were reported to experience eGFR decrease; most reductions in eGFR were manageable by dose modification. The incidence of serious AEs was similar in both groups at 3 and 6 months. In the first 3 months, significantly more patients in AURORA 1 achieved >25% UPCR reduction from baseline (81.3% AURORA 1, 65.6% ALMS; p=0.011); the proportions of patients achieving UPCR ≤0.5 mg/mg and >50% UPCR reduction from baseline were numerically greater in the voclosporin arm; the differences were not statistically significant.

Conclusion

The above findings affirm the KDIGO 2023 recommendation that a voclosporin-based, triple-immunotherapy regimen should be considered as initial therapy in active LN.

Funding

  • Commercial Support – Aurinia Pharmaceuticals Inc.