NEW YORK (Reuters Health)—Voclosporin (Lupkynis) in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids improves renal response rates compared with use of these agents alone in patients with in lupus nephritis, according to a company-funded study.
“Lupus nephritis can be a devastating condition if not diagnosed and managed early. These data establish voclosporin as an efficacious and safe, rapid-acting new treatment option for patients in need,” says Brad H. Rovin, MD,of Ohio State University Wexler Medical Center, Columbus, in a company press release.
Voclosporin, a novel calcineurin inhibitor, was approved in combination with immunosuppressive therapy to treat adults with active lupus nephritis by the U.S. Food and Drug Administration (FDA) in January.
Dr. Rovin and colleagues conducted a double-blind, randomized phase 3 trial involving 357 patients in 27 countries. They were randomized to oral voclosporin (23.7 mg twice daily) or placebo, along with MMF (1 g twice daily) and rapidly tapered low-dose oral steroids.
The primary endpoint of complete renal response at week 52 was achieved in significantly more patients in the voclosporin group (41%) than in the placebo group (23%) giving an odds ratio of 2.65 (P<0.0001).
The proportion of patients achieving a complete renal response at week 24 was also significantly higher in the voclosporin group than the placebo group.
Serious adverse events were seen in 21% of patients in both groups. Six patients died during the study period, five of whom were in the placebo group. None of the deaths were considered to be treatment related.
The most frequent serious adverse event involving infection was pneumonia, seen in seven patients in the active treatment group and in eight patients in the placebo group.
“This study,” Dr. Rovin tells Reuters Health by email, “provides important validation of the benefits of early intervention in lupus nephritis and the potential of this new dedicated treatment option for the lupus nephritis community.”
The ongoing AURORA 2 extension study will provide safety and efficacy data on an additional two years of treatment. “Lupus nephritis is chronic disease and it is important to evaluate the long-term effects of therapeutic interventions in terms of both efficacy and safety,” the researchers write.
Dr. Rovin has received personal fees from Aurinia and a number of authors are employees and holders of company stock.
Reference
- Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): A double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070–2080. Epub 2021 May 7.
