Voclosporin exhibits positive long-term safety, efficacy data over 3 years
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Key takeaways:
- There were no “unexpected” safety signals at 3 years, the researchers said.
- Patients receiving voclosporin demonstrated better outcomes including stability of renal function.
Long-term voclosporin is safe and efficacious for the treatment of lupus nephritis over 3 years, according to data published in Arthritis & Rheumatology.
“Voclosporin is a novel calcineurin inhibitor (CNI) approved in the United States, and more recently in Europe, for the treatment of adult patients with active [lupus nephritis (LN)] in combination with background immunosuppression,” Amit Saxena, MD, of the New York University School of Medicine, and colleagues wrote. “Voclosporin is associated with a favorable metabolic profile with regard to lipids and glucose, and a predictable pharmacokinetic profile resulting in no need for the therapeutic drug monitoring required of other CNIs.”
To continue investigating the impact of long-term voclosporin (Lupkynis, Aurinia) to 3 years, Saxena and colleagues analyzed data from patients enrolled in AURORA 2, a phase 3, double-blind, 24-month continuation study, itself a follow-up on the initial AURORA 1 trial, which ran for 12 months. Patients were eligible for AURORA 2 if they participated in AURORA 1 and were recommended by an investigator to continue receiving immunosuppressive therapy.
Following the initiation of AURORA 2, patients continued to receive the same doses of voclosporin they received during AURORA 1 through 36 months, marking an additional 24 months from the end of AURORA 1. The primary outcomes were the safety and tolerability of voclosporin through 3 years in patients with lupus nephritis. The researchers evaluated adverse events and continued to analyze efficacy outcomes, including partial renal response, good renal outcomes, and renal and non-renal flares.
AURORA 2 included a total of 216 patients, of whom 86.1% completed the trial. According to the researchers, there were no “unexpected” safety signals. Among patients who received voclosporin, 86% experienced adverse events, compared with 80% in the placebo group. Patients who received voclosporin demonstrated higher rates of glomerular filtration — 10.3% vs. 5% — and hypertension — 8.6% vs. 7% — compared with those who received a placebo. Additionally, patients treated with voclosporin had improved proteinuria over 3 years — 50.9% vs. 39% (OR = 1.74; 95% CI, 1-3.03) — compared with the placebo group.
“This analysis confirms the safety, tolerability and efficacy of voclosporin reported previously, with no new or unexpected safety signals observed with an additional 2 years of treatment,” Saxena and colleagues wrote. “We propose that the rapid renal response achieved with voclosporin treatment has beneficial long-term consequences, supported by stable kidney function over the 3-year treatment period.”
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