Jeffrey Siegel, MD, Assumes New Position as Director for New Office of Drug Evaluation Sciences at the FDA On Feb. 16, Jeffrey Siegel, MD, became the director of the recently created Office of Drug Evaluation Sciences at the U.S. Food & Drug Administration (FDA). The move, he says, “puts together many of the different things…
The difference between CastleÂman disease and Castleman-like disease may be subtle, but it comes with significant ramifications. Case Presentation This case involves a pregnant 19-year-old woman who presents over multiple hospitalizations with concerns for systemic lupus erythematosus and macrophage activation syndrome. At 36 weeks’ gestation, the patient’s weight had dropped from 215 lbs. to 170…
The impressive progress of medical knowledge and technology reinforces our trust in the scientific methodology that made it all possible. However, that progress also creates risks related to the primary goal of medical care: to serve our patients’ interests and enjoyment of life in the best possible way. In this article we present our views…
Some were furious. State by state, laws were enacted to ensure compliance. In most states, the laws were accompanied by a modest fine, as an added incentive. By the time the laws were written, most understood they were based on good science and common sense. The potential to save lives and prevent tragedy was finally…
The COVID-19 pandemic exacerbated wide disparities that exist in the U.S. healthcare system. During the pandemic, the clinical practice in the Section of Rheumatology, Allergy & Immunology at Yale School of Medicine (YSM), New Haven, Conn., rapidly pivoted from face-to-face visits to telehealth to keep our patients and providers safe. Many patients quickly adapted and…
Furuta et al. evaluated the benefits of reducing glucocorticoid doses during remission induction for patients with ANCA-associated vasculitis. The researchers found a reduced-dose-glucocorticoid-plus-rituximab regimen was noninferior to a regimen of high-dose glucocorticoids plus rituximab in these patients.
About 30% of patients with psoriasis have psoriatic arthritis (PsA), a complex, multi-faceted, chronic, inflammatory musculoskeletal and skin disease for which the treatment has changed considerably over the past few years.1 Biosimilars and other new drugs have become a therapeutic turning point for many patients suffering from rheumatic illnesses, including PsA. The treatment of PsA…
Amid spirited discussions on drug pricing and insurance challenges, participants got hands-on experience advocating for current bills regulating prior authorization and pharmacy benefit managers.
On Oct. 8, ChemoCentryx Inc. announced that the U.S. Food & Drug Administration (FDA) has approved avacopan (TAVNEOS), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms…
Initial 24-week data from a study of patients with psoriatic arthritis (PsA) show that treatment with guselkumab improved symptoms and resulted in a higher ACR20 response than placebo in patients who could not tolerate, or did not respond to, treatment with a tumor necrosis factor inhibitor (TNFi).