Voclosporin in SLE - Long-Term Safety and Efficacy Save
The AURORA 2 study evaluated the long-term safety and efficacy of voclosporin (VOC) lupus nephritis (LN) patients and, after three years, demonstrated long term safety and efficacy following the one-year AURORA 1 study.
The previously published AURORA trials showed 1 year superiority of VOC over placebo in achieving a complete renal response (CRR) (43.7% vs. 23.3%, OR 2.76; 95% CI 1.88, 4.05 p<0.0001). Enrolled patients continued their double-blinded treatment with VOC or placebo in AURORA 1 in the AURORA 2 trial (while maintaing background mycophenolate mofetil and low-dose glucocorticoids).
A total of 216 lupus nephritis patients enrolled in AURORA 2. Treatment was well tolerated with 86.1% completing the study and no new safety signals were seen with prolonged treatment. VOC did have more investigator reported AEs of GFR decrease (10.3% vs 5.0%) and hypertension (8.6% vs 7.0%, vs PBO).
VOC treated patients noted more improved proteinuria over three years and more complete renal responses (50.9% vs 39.0%; odds ratio 1.74; 95% CI 1.00, 3.03).
Long-term voclosporin treatment appears safe and efficacious in LN patients.
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