In an ACR Convergence 2022 session, Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery, New York City, discussed the use of sarilumab as a potential glucocorticoid-sparing therapy in a phase 3 study in patients with treatment-refractory polymyalgia rheumatica (PMR), one of the most common inflammatory diseases…
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FDA Approves Sarilumab for Adults with Glucocorticoid-Resistant Polymyalgia Rheumatica
On Feb. 28, 2023, the U.S. Food & Drug Administration (FDA) approved sarilumab (Kevzara) for the treatment of adults with polymyalgia rheumatica (PMR) for whom glucocorticoids have proved inadequate or who cannot tolerate a glucocorticoid taper.1,2 Sarilumab is an interleukin (IL) 6 receptor antagonist. In May 2017, the FDA initially approved the agent for the…
How to Treat Refractory Polymyalgia Rheumatica
Patients with polymyalgia rheumatica (PMR) who had relapsed while tapering glucocorticoid therapy were more likely to achieve sustained remission at one year and have a lower glucocorticoid exposure if they were treated with sarilumab (Kevzara) plus a rapid, 14-week glucocorticoid taper than if they received placebo plus a standard, 52-week glucocorticoid taper. This is according…
How Prevalent Is Subclinical Giant Cell Arteritis in Polymyalgia Rheumatica?
Background/Purpose It has been reported that 20–50% of patients with polymyalgia rheumatica (PMR) have subclinical giant cell arteritis (GCA). The natural history of ultrasound-defined subclinical GCA in PMR is not known. Methods Twenty-five newly diagnosed PMR patients who met a clinical diagnosis for PMR, verified by two rheumatologists, were examined by ultrasound. All six branches…
Gout & Its Comorbidities
At ACR Convergence 2023, experts addressed important topics in gout research, including treating and preventing gout flares, lowering urate levels and managing comorbidities, as well as racial inequities in gout treatment, disease burden and outcomes.
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.
Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals
An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
Heterogeneity in Lupus: Lessons from the Autoimmune Centers of Excellence
SAN DIEGO—The Autoimmunity Centers of Excellence (ACE) are a cooperative group funded by the National Institute of Allergy and Infectious Diseases (NIAID) that conduct basic and clinical research on autoimmune diseases.1 ACEs focus on treatment and prevention strategies that induce immune tolerance or modulate the immune system. The goal is to facilitate collaboration across clinicians…
Old Disease, New Tricks: A Novel Approach to Understanding Gout
SAN DIEGO—Gout has sometimes been called the disease of kings, not only because of the fact that purine-rich foods were long affordable only to wealthier individuals, but also because the disease has been around since the monarchies that existed centuries ago. However, with groundbreaking research leading to a better understanding of gout, we can now…
Rheum in the Court, Law in the Clinic: Health Policy in Global Rheumatology
SAN DIEGO—At ACR Convergence 2023, panelists presented information concerning several policy issues that affect rheumatologists & their patients, including abortion access & the WHO’s Essential Medicine List.
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