AURORA 2
Trial question
What is the effect of long-term voclosporin treatment in patients with lupus nephritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
89.0% female
11.0% male
N = 216
216 patients (193 female, 23 male)
Inclusion criteria: adult patients with lupus nephritis requiring continued immunosuppressive therapy
Key exclusion criteria: eGFR ≤ 45 mL/min; congenital or acquired immunodeficiency; lymphoproliferative disease or previous total lymphoid irradiation; severe CVD, liver dysfunction, or COPD or asthma requiring oral corticosteroids
Interventions
N=116 voclosporin (at a dose of 23.7 mg BID for 2 additional years)
N=100 placebo (matching placebo for 2 additional years)
Primary outcome
Complete renal response
50.9
39
50.9 %
38.2 %
25.4 %
12.7 %
0.0 %
Voclosporin
Placebo
Borderline significant increase ▲
Borderline significant increase in complete renal response (50.9% vs. 39%; OR 1.74, 95% CI 1 to 3.03)
Secondary outcomes
No significant difference in partial renal response (74.1% vs. 69%; OR 1.39, 95% CI 0.75 to 2.58)
Significant increase in good renal outcome (66.4% vs. 54%; OR 1.78, 95% CI 1.01 to 3.12)
No significant difference in renal flare (23.8% vs. 26%; OR 0.85, 95% CI 0.42 to 1.73)
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with lupus nephritis requiring continued immunosuppressive therapy, voclosporin was superior to placebo with respect to complete renal response.
Reference
Amit Saxena, Ellen M Ginzler, Keisha Gibson et al. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the Phase 3 AURORA 2 clinical trial. Arthritis Rheumatol. 2023 Jul 19.
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