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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.
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RheumNow Podcast – Booster Shots for COVID (8.13.2021)
Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com.
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Early MRI Sacroiliac Improvement with JAK Inhibition
The TORTUGA trial tested filgotinib, a JAK1 inhibitor, in active ankylosing spondylitis (AS) patients and was shown to be both effective and capable of retarding sacroiliac (SI) joint erosions as early as 12 weeks.
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Combo Methotrexate and Leflunomide Safety in RA
Methotrexate and leflunomide (LEF) are the most widely prescribed DMARDs worldwide; yet biologic DMARDs are the newest and best selling agents for rheumatoid arthritis worldwide.
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ICYMI: RheumNow Podcast – Tofacitinib Safety Concerns
Dr. Jack Cush reviews and discusses the news and journal reports from the past week on RheumNow.com.
Read ArticleICYMI: 2020 Rheumatology Year in Review
2020 was historic, memorable and game-changing. Under the cloud of COVID-19, there were many significant and memorable advances and setbacks for the rheumatology world. In our accounting of most read articles for 2020, (not surprisingly) 17/20 were COVID-related.
Read ArticleICYMI: Psoriatic Disease Management - RNL 2021 Highlights
This year’s coverage of psoriatic arthritis was once again, both exciting and informative. Topics included an overview of the latest therapeutic options, an excellent discussion on psoriasis specifically, and the epidemiology of psoriatic arthritis.
Read ArticleICYMI: New GRAPPA 2021 PsO and PsA Treatment Recommendations
The evidence-based recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis were presented at #EULAR2021. The goal (as per 2009 recommendations) was “To develop recommendations, based upon the best scientific evidence, for the optimal treatment of patients with PsA” Dr. Laura Coates, Oxford detailed in abstract #OP0229. Since the last update in 2015, there have been multiple changes, which are highlighted here.
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