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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.
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.
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.
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.
The American College of Rheumatology has issued an updated version of its COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases following recent recommendations from the CDC that certain immunocompromised patients receive a third dose of an availabl
A prospective study evaluated the value and associations with morning stiffness in patients with clinically suspect arthralgia, and found that the presence of morning stiffness increases the odds of inflammation (as detected by CRP and MRI synovitis).
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