ATLANTA—The ACR is actively engaged with the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for…
One of the oldest treatment options in rheumatology, colchicine, may be an effective and inexpensive treatment to prevent complications in non-hospitalized patients with COVID-19, particularly in men, according to the results of large global study.
In July, the FDA approved the use of Octagam 10%, an intravenous immunoglobulin solution, to treat dermatomyositis in adults after an international study demonstrated the treatment’s safety and efficacy.
ATLANTA—The American College of Rheumatology (ACR) today applauded the U.S. Centers for Medicare & Medicaid Services’ (CMS) decision to withdraw a proposed rule to implement the “Most Favored Nation” (MFN) payment model for Part B drugs. Leaders felt the policy would have dramatically disrupted patient access to critical therapies needed to manage rheumatic diseases and…
On May 6, the U.S. Food & Drug Administration’s (FDA’s) Arthritis Advisory Committee narrowly voted in support of avacopan, a C5a receptor inhibitor, for the treatment of adult patients with anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Although the panelists were excited about the possibility of a steroid-sparing therapy, some raised questions about whether results from…
Discovered more than 3,000 years ago, colchicine is one of the oldest drugs still in use today. Like most old remedies, colchicine is a chemical substance found in many plants, most notably in colchicum autumnale, known as wild saffron or autumn crocus. It was mentioned in the oldest Egyptian medical text, Ebers Papyrus (circa 1550…
Although rheumatologists prescribe tumor necrosis factor inhibitors (TNFi’s) to treat several rheumatic diseases, they recognize immunogenicity influences the efficacy and safety of TNFi’s. Example: The formation of anti-drug antibodies can affect infusion reactions and cause low-serum drug levels and therapeutic failure. The induction phase is a period of high incidence of immunogenicity, and observational data…
In a small study, patients with GCA maintained remission after receiving three days of treatment with methylprednisolone followed by tocilizumab.
In a study, Janus kinase inhibitors proved effective for patients with difficult-to-treat rheumatoid arthritis (RA).
(Reuters)—AbbVie Inc. and ELi Lilly & Co. are facing fresh delays in the approval of their respective rheumatoid arthritis (RA) drugs for treating the chronic skin disease eczema as the U.S. health regulator assesses the new class of treatment over safety concerns. The treatment, called Janus kinase inhibitors (jakinibs), blocks inflammation-causing enzymes known as Janus…