Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
3 AC&R Study Summaries: Lupus Fog, SSc Variance By Ethnicity & Tuberculosis Screening in New DMARD Users
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….
Tofacitinib Increases Risk of Venous Thromboembolism
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…
FDA Approves Sarilumab for pJIA
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.
FDA Updates Safety & Efficacy Information for Voclosporin
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…
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