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 Cells: Are We Closer To Drug-Free Remission Than We Think?
Most Sunday mornings, I make myself an exceptional cup of pour-over coffee and sit down on my deck with the latest issue of the New England Journal of Medicine. I check out the image of the week. I read the case report with pen in hand, racing to diagnose the patient before the authors spill…
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.
Methotrexate Shows Promise for Hand Arthritis
Methotrexate—an affordable, established drug for rheumatoid arthritis—may also be helpful for patients suffering from osteoarthritis (OA) of the hand, a recent study reports.1 Treatment of hand OA and inflammation with 20 mg of methotrexate for six months had a moderate, but potentially clinically meaningful, effect on reducing pain and stiffness in patients with symptomatic hand…
Pharmacy Benefit Managers Under Scrutiny
“When pharmacy benefit managers [PBMs] came into being 30 years ago, they were seen as an important component of the prescription distribution system [because] they could guide benefits and money between the patient, pharmacy and the manufacturer,” says Angus Worthing, MD, president of the Alliance for Transparent & Affordable Prescriptions (ATAP). Health insurance companies hire…
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.
The Prospect of Rheumatoid Arthritis Prevention
Rheumatoid arthritis (RA) is treatable, and for that, we should be grateful. But wouldn’t it be better if we could prevent it from even happening? Recent data from a study in China demonstrated some interesting results. Could an older type of diabetes medication be the answer we’ve been looking for? Background Preclinical studies have suggested…