The European Commission approved tofacitinib citrate to treat two pediatric conditions, as well as a prolonged-release version of the medication designed to treat adults with active PsA.
FDA Requires New Boxed Warnings on JAK Inhibitors, Places Restrictions on Use
On Sept. 1, the U.S. Food & Drug Administration (FDA) announced that it is requiring revisions to the Boxed Warning for the Janus kinase (JAK) inhibitors Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots and death.1 Recommendations for healthcare professionals will include…
ACR Guidance on Tocilizumab Allocation During Shortage
In June, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for tocilizumab (Actemra) for treatment of hospitalized COVID-19 adults and children who are receiving systemic corticosteroids and supplemental oxygen. Since this announcement, the tocilizumab manufacturer, Genentech, has not been able to produce enough product to meet the higher demand. The…
20 Years of RA Data: First-Line Biologic & Targeted Synthetic DMARD Trends
Data from a single-center registry shines light on 20 years of trends in first-line, biologic disease-modifying anti-rheumatic drug prescriptions for patients with rheumatoid arthritis.
2-Year Extension Study Supports Voclosporin to Treat Patients with Lupus Nephritis
Research has shown voclosporin in combination with MMF and low-dose steroids benefits patients with lupus nephritis, significantly increasing the speed of remission. New data from an ongoing extension study demonstrate a positive risk/benefit profile.
Infections, Low IgG Seen in Kids Receiving Rituximab for Rheumatic Disease
NEW YORK (Reuters Health)—A significant proportion of children with rheumatic diseases develop new-onset hypogammaglobulinemia and infections following treatment with the monoclonal antibody rituximab, according to new U.S. research. “Increased risk appeared to be mediated, at least in part, by exposure to pulse dose corticosteroids,” write Marc Natter, MD, of Harvard Medical School and Boston Children’s…
EU Evaluates Tocilizumab as COVID-19 Treatment
(Reuters)—Europe’s drugs regulator said on Monday it was evaluating the use of Roche’s arthritis drug, tocilizumab, in hospitalized adults with severe COVID-19, its latest review of a potential coronavirus treatment. Tocilizumab, sold by Roche as Actemra and RoActemra, has shown promise in clinical trials in treating COVID-19, and was approved by U.S. health regulators in…
ACR Update on Tocilizumab Shortages
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…
International Study Finds Colchicine Promising as Outpatient Treatment for COVID-19
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.
FDA Approves IVIG to Treat Adults with Dermatomyositis
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.
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