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…
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…
Study: Most Patients with PMR Aren’t Getting Steroid-Sparing Agents in First 2 Years
A minority of patients with polymyalgia rheumatica (PMR) who were new to rheumatology practice were prescribed steroid-sparing agents through two years of follow-up. This is according to a large, U.S.-based cohort study, published in Arthritis Care & Research, which also found that nearly two-thirds of the patients remained on glucocorticoids beyond one year.1 “Our study…
When a JAK Inhibitor Fails
What Are the Therapeutic Alternatives When a Janus Kinase Inhibitor Fails to Work? SAN DIEGO—Treatment alternatives after Janus kinase (JAK) inhibitor failure in real-life conditions were analyzed and presented at ACR Convergence 2023 by Pablo Francisco Muñoz Martínez, a rheumatologist at the Hospital Universitario y Politécnico La Fe, Sagunto, Spain.1 JAK inhibitors are newer, targeted…
Study Probes Corticosteroid Dependence in Polymyalgia Rheumatica
Background/Purpose Polymyalgia rheumatica (PMR) treatment is primarily based on long-term corticosteroids, which results in significant toxicities. Studies have shown that patients with PMR are exposed to years of corticosteroid treatment.1,2 In a single academic center cohort, we found that 76% of patients remained on steroids at the end of two years.3 In a second cohort…
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…
Study: Patients with PMR Experience Fatigue, Sleep Disturbance & Mood Disorders
Background/Purpose Polymyalgia rheumatica (PMR) is typified by pain and stiffness of the shoulder and hip girdles. Previous qualitative studies have highlighted the importance to patients of additional symptoms, including fatigue and sleep disturbance. These features of PMR are less recognized by clinicians and have not yet been quantified in the literature. Further, the adequacy of…
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.
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