Amit Saxena, Ellen M. Ginzler, Keisha Gibson, Bancha Satirapoj, Adolfina Elizabeth Zuta Santillán, Olena Levchenko, Sandra Navarra, Tatsuya Atsumi, Shinsuke Yasuda, Nilmo Noel Chavez‐Perez, Cristina Arriens, Samir V. Parikh, Dawn J. Caster, Vanessa Birardi, Simrat Randhawa, Laura Lisk, Robert B. Huizinga, Y. K. Onno Teng

Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial

  • Immunology
  • Rheumatology
  • Immunology and Allergy
Save to CiteDrive Show PDF

ObjectiveAURORA 2 evaluated the long‐term safety, tolerability, and efficacy of voclosporin compared to placebo in patients with lupus nephritis (LN) receiving an additional two years of treatment following completion of the one‐year AURORA 1 study.MethodsEnrolled patients continued their double‐blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low‐dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs) and biochemical and hematological assessments. Efficacy was measured by renal response.ResultsA total of 216 patients enrolled in AURORA 2. Treatment was well tolerated with 86.1% completing the study and no unexpected safety signals. AEs occurred in 86% and 80% of patients in the voclosporin and control groups, respectively, with an AE profile similar to that seen in AURORA 1, albeit with reduced frequency. Investigator reported AEs of both glomerular filtration rate (GFR) decrease and hypertension occurred more frequently in the voclosporin than the control group (10.3% vs 5.0%, and 8.6% vs 7.0%, respectively). Mean corrected estimated GFR (eGFR) was within the normal range and stable in both treatment groups. eGFR slope over the two‐year period was −0.2 mL/min/1.73 m2 (95% confidence interval [CI] −3.0 to 2.7) in the voclosporin group and −5.4 mL/min/1.73 m2 (95% CI −8.4 to −2.3) in the control group. Improved proteinuria persisted across three years of treatment, leading to more frequent complete renal responses in patients treated with voclosporin (50.9% vs 39.0%; odds ratio 1.74; 95% CI 1.00–3.03).ConclusionData demonstrate the safety and efficacy of long‐term voclosporin treatment over three years of follow‐up in patients with LN.image

Need a simple solution for managing your BibTeX entries? Explore CiteDrive!

  • Web-based, modern reference management
  • Collaborate and share with fellow researchers
  • Integration with Overleaf
  • Comprehensive BibTeX/BibLaTeX support
  • Save articles and websites directly from your browser
  • Search for new articles from a database of tens of millions of references
Try out CiteDrive

More from our Archive