A proposal for biosimilar use in the 2025 budget would allow substitution of any biosimilar for its reference product without an interchangeable designation. The hope is to increase biosimilar uptake, with the subsequent potential to increase product “competition, access and affordability.”1 In the 2025 budget proposal, the Biden administration noted that the legal distinction between…
Checking blood levels of commonly used disease-modifying anti-rheumatic drugs (DMARDs) has gained widespread attention in the rheumatology community, even resulting in a recent guidance document from EULAR for biologics.1 Although a highly useful tool, drug level measurement in rheumatology is not without challenges; many of our drugs violate the basic principles of pharmacology that we…
In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
A Shift in Prescribing Patterns Safety issues prompt discontinuation of tofacitinib By Stephanie Song, MD, & Joshua F. Baker, MD, MSCE Why was this study done? The ORAL Surveillance study highlighted risks of cardiac events, thromboembolism (VTE) and malignancy associated with use of Janus kinase inhibitors (JAKi). We sought to determine the impact of safety…
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…
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…
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…
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…
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…
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…