AURORA 2 trial demonstrates the safety and efficacy of long-term voclosporin in lupus nephritis

The findings of the AURORA 2 phase 3 trial published in the recent issue of Arthritis & Rheumatology have reported the long-term safety, tolerability, and efficacy of voclosporin treatment over 3 years. Patients with lupus nephritis (LN) receiving an extra two years of treatment after the one-year AURORA 1 study’s completion were included in AURORA 2. 

Dr. Amit Saxena and his team evaluated the safety and long-term efficacy of voclosporin in 216 individuals with LN. Around 86% of the participants completed the study. The medication was found to be well tolerated, and long-term treatment did not provide any new safety signals. In comparison to the placebo, voclosporin group experienced both glomerular filtration rate reduction and hypertension adverse events more frequently (10.3% vs. 5% and 8.6% vs. 7%) than the controls. Furthermore, improved proteinuria was sustained in patients receiving voclosporin treatment throughout the three years, leading to more frequent complete renal responses (50.9% vs. 39.0%; odds ratio 1.74; 95% CI 1.00, 3.03). 

Data from 2022 AURORA 2 continuation study has reported that voclosporin was safe and well-tolerated, with a safety profile similar to the control over the course of three years of treatment. Additionally, even without the use of conventional high-dose steroids, AURORA 2 maintained the significant reductions in proteinuria that were first attained in AURORA 1.  

In AURA-LV, two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) were compared to placebo in a phase 2 multicenter, randomized, double-blinded, placebo-controlled trial. This study compared the induction of remission in LN along with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids. Complete renal remission (CRR) at 24 weeks was the primary goal, and CRR at 48 weeks was the secondary endpoint. CRR was attained by 32.6% of individuals in the study in week 24. At week 24, 32.6% of the low-dose voclosporin group’s patients, 27.3% of the high-dose voclosporin group’s subjects, and 19.3% of the placebo group’s subjects all obtained CRR (OR=2.03 for low-dose voclosporin vs. placebo). These findings indicate that, when mycophenolate mofetil and corticosteroids are combined with low-dose voclosporin for the induction therapy of active LN, the renal response is superior to that of mycophenolate mofetil and corticosteroids alone.  

The current phase 3 trial underscores the potential of voclosporin as a valuable therapeutic option for LN patients, offering a well-tolerated and effective long-term treatment strategy. Further research and clinical trials are warranted to better understand the optimal dosing regimens and potential benefits of voclosporin in the treatment of LN. 

References 

  1. Saxena A, Ginzler EM, Gibson K, Satirapoj B, Zuta Santillan AE, Levchenko O, et al. Safety and efficacy of long‐term voclosporin treatment for lupus nephritis in the Phase 3 AURORA 2 clinical trial. Arthritis & Rheumatology. 2023 Jul 19 
  2. Gibson K, Teng Y, Hodge L, Collins C. S06.2 Long-term efficacy and safety of voclosporin with mmf and low-dose steroids: data from the aurora 2 continuation study. Lupus Science & Medicine. 2022 Oct 1;9(Suppl 2). 
  3. Rovin BH, Solomons N, Pendergraft III WF, Dooley MA, Tumlin J, Romero-Diaz J, et al. A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney international. 2019 Jan 1;95(1):219-31. 

 

 

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