AURORA 2 Voclosporin, a novel calcineurin inhibitor (CNI), 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. AURORA 2, a double-blind, phase 3 study, evaluated the longterm safety, tolerability and efficacy of voclosporin…
Lupus nephritis is one of the leading causes of mortality for patients with systemic lupus erythematosus (SLE), and patients with both SLE and end-stage renal disease have standardized mortality ratios more than 60 times that of patients with SLE with normal kidney function.1 The good news: Rheumatologists now have not one, but two approved options…
The FDA’s latest label change for voclosporin adds data demonstrating its safety and efficacy, as well as a sustained renal response, in patients with lupus nephritis through three years of treatment.
AURORA 2, a double-blind, phase 3 study, evaluated the long-term safety, tolerability and efficacy of voclosporin compared to placebo in patients with lupus nephritis receiving an additional two years of treatment following completion of the one-year AURORA 1 study. Patients enrolled in AURORA 2 continued to receive the same treatment randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low-dose glucocorticoids. Saxena et al. propose that the rapid renal response achieved with voclosporin treatment has long-term benefits, supported by stable kidney function over the three-year treatment period.
How does a rheumatologist treat a pregnant woman when many medications are not approved for pregnancy or safety data are limited?
Thomas Dörner, MD, reviewed the current state of systemic lupus erythematosus (SLE) management, providing updates on novel therapies and insights into the pathogenesis of SLE.
ACR Convergence 2021—The Great Debate at the meeting sparked a thoughtful discussion on the future of lupus nephritis treatment strategies, with experts saying clinicians should be open to new ways of approaching patient care. In the past year, approvals of the monoclonal antibody belimumab and the calcineurin inhibitor voclosporin for use in lupus nephritis (when…
Research has shown voclosporin in combination with MMF and low-dose steroids benefits patients with lupus nephritis, significantly increasing the speed of remission. New data from an ongoing extension study demonstrate a positive risk/benefit profile.
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…
At the 2021 ACR State-of-the-Art Clinical Symposium, Saira Sheikh, MD, associate professor of Medicine and director of the Rheumatology Lupus Clinic, University of North Carolina, Chapel Hill, provided an update on the past, present and future of the management of systemic lupus erythematosus (SLE). This year, hydroxychloroquine received a great deal of attention, given early…