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Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial by 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 is a Medicine article available to read on EtoBox.
What is Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial about?
## Objective AURORA 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. ## Methods Enrolled 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. ## Results A 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 no
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- Author
- 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
- Publisher
- Wiley
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)