All News
FDA Review of Vaping Products Extended
The FDA has again extended its decision on whether the manufacturers of vaping products can market their e-cigarettes in the United States.
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Lymphoma in RA: Disease Activity Matters
Among patients with rheumatoid arthritis (RA), the strongest risk factors for the development of lymphoma were disease activity and severity, French researchers found.
In a multivariate analysis, having a high Disease Activity Score in 28 joints (DAS28) at baseline conferred twice the risk for lymphoma, with an odds ratio of 2.09 (95% CI 1.41-3.38), according to Gaetane Nocturne, MD, of Hôpital Bicêtre in Ile-de-France, and colleagues.
RheumNow Podcast – JAK Inhibitor Warnings from the FDA
FDA JAK inhibitor warnings and what it means (also: what do you think?); other news released this week; and, two questions submitted from listeners. Dr. Cush discusses this and more in this week's podcast.
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Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors
Dr. Jack Cush is joined by Drs. Roy Fleischmann (Dallas), Allan Gibofsky (NYC), and Artie Kavanaugh (San Diego) to discuss the 9/2/21 FDA Drug Safety Communication regarding the cardiovascular and cancer risks arising from the Pfizer 1133 (ORAL Surveillance) tofacitinib study, but also applied to baricitinib and upadacitinib.
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FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors
Today, Sept.1st, the FDA announced its decision regarding tofacitinib's safety concerns from the Oral Surveillance study - handing down warnings for not only Pfizer's JAK inhibitor, but also for other marketed JAK inhibitors from AbbVie and Eli Lilly & Co.
These safety concerns arise from the Oral Surveillance study - a large, post-marketing, safety trial of tofacitinib versus adalimumab in high risk patients. New warnings about the risks of cardiac events, death and cancer will appear as a revision to the "boxed warnings" in the product label (package insert) for all JAK inhibitors - tofacitinib, baricitinib and upadacitinib.
TNF Inhibitor Induced IgA Vasculitis in IBD
A new descriptive series shows an uncommon association between IgA vasculitis (IgAV) and inflammatory bowel diseases (IBD), with most cases interestingly arising after or during anti-TNF-α therapy.
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Drug Choices After First TNF Inhibitor in RA
TNFi are frequently used first line in RA patients; and a new analysis shows that repeat use of TNFi dominates over the use of non-TNFi biologics when the initial TNFi therapy has failed. This retrospective analysis of commercial insurance records analyzed the patterns of drug use in adult RA patients who switched to their second biologic or targeted disease-modifying antirheumatic drug.
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RheumNow Podcast – COVID Marching Amidst the Madness (8.27.2021)
We have a lot of news, information and approvals to review and discuss, though I need to begin with what's weighing heavily on my mind. After, we'll dive into what we learned this week.
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