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.
CAR-T Cell Therapy in Autoimmune Disease: The Next Frontier
Chimeric antigen receptor (CAR) T cell therapy has the potential to fundamentally shift the treatment of autoimmune disease. During his presentation at EULAR 2024, Georg Schett, MD, provided an overview of this treatment process and described the promising findings of the latest research.
FDA Approves Tocilizumab Biosimilar; Plus New Lupus Drug in Early Trials
The FDA has approved tocilizumab-aazg (Tyenne), the first tocilizumab biosimilar, for treating rheumatic diseases, as well as the new drug application for CB-101, a chimeric antigen receptor T cell therapy, for treating lupus nephritis and extra-renal lupus.
New Indications Possible for Bimekizumab-bkzx
The FDA has accepted applications for three new indications for bimekizumab-bkzx, a humanized interleukin (IL) 17A and IL-17F antagonist: psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
Biosimilars to Denosumab Approved with an Interchangeable Designation
The FDA has approved the first interchangeable biosimilars for denosumab.
Optimizing DMARD Use in Older Adults with Rheumatoid Arthritis
SAN DIEGO—Older adults with rheumatoid arthritis (RA) comprise two groups: those who have lived with diagnosed RA since an early age (young-onset RA) and those who have new-onset RA diagnosed at an older age (≥65 years), known as late-onset RA or, formerly, as elderly onset RA.1 Individuals with late-onset RA have more acute and systemic…
FDA Proposal for Biosimilar Use in 2025 Budget
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…
When to Check Drug Levels & Why
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…
FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID
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.
3 AC&R Study Summaries: Prescribing Patterns, PMR & Glucocorticoids, & Infection Screening
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…
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