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.
Long-Term Voclosporin Treatment Looks Promising for Lupus Nephritis Patients
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.
Rheumatology Medications with Limited Safety Data: How Do We Use Them in Pregnant Patients?
How does a rheumatologist treat a pregnant woman when many medications are not approved for pregnancy or safety data are limited?
What’s New in SLE: Pathogenesis & Novel Therapies
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.
The Great Debate: Belimumab vs. Voclosporin in Lupus Nephritis
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…
2-Year Extension Study Supports Voclosporin to Treat Patients with Lupus Nephritis
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.
Add-On Voclosporin Improves Outcomes in Lupus Nephritis
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…
A 2021 Update on Lupus Management & Treatment
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…
FDA Approves Belimumab & Voclosporin for Lupus Nephritis
In December, the FDA approved belimumab, the first drug approved to treat lupus nephritis, an historic action that was rapidly followed in January by the approval of a second treatment for lupus nephritis, voclosporin.
Voclosporin Promising for Lupus Nephritis
In a recent clinical trial, voclosporin proved safe and effective at both low and high doses as a treatment for lupus nephritis…