Lupus Fog? By Laura C. Plantinga, PhD, Patricia P. Katz, PhD, S. Sam Lim, MD, MPH, C. Barrett Bowling, MD, MSPH, & Jinoos Yazdany, MD, MPH Why was this study done? Perceived cognitive impairment (i.e., lupus fog) is common in systemic lupus erythematosus (SLE). However, comprehensive, multidomain assessments of objective cognitive function are rarely performed….
Background & Objectives The ORAL Surveillance trial (NCT02092467), a postauthorization safety study of tofacitinib in patients with rheumatoid arthritis (RA) aged 50 years or older with at least one additional cardiovascular risk factor, found a dose-dependent increase in venous thromboembolism (VTE) and pulmonary embolism (PE) events when patients were treated with tofacitinib vs. a tumor…
The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.
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.
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.
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.
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.
The FDA has approved the first interchangeable biosimilars for denosumab.
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…
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…