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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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Rare Risks Associated with BNT162b2 mRNA Covid-19 Vaccine
The current NEJM reports that the use of the Pfizer mRNA vaccine (BNT162b2) demonstrated a very low risk for certain serious adverse events, including the risk of myocarditis (1 to 5 events per 100,000 persons).
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ACR Guidance on Timing of 3rd Dose Booster with Immunomodulatory Drugs
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
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Rheumatic Events With Checkpoint Inhibitors: Tumor Type Matters
Among the factors that were associated with an increased risk for the development of rheumatic immune-related adverse events following cancer treatment with immune checkpoint inhibitors (ICIs) was the type of malignancy involved, a large case-control study found.
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RheumNow Podcast – Driving in Pain (8.20.2021)
You know, I'm a very good driver. We all think we're great drivers - but consider what it's like to drive in pain: would you be a good driver? Also, I want you to consider the diagnosis of calcium pyrophosphate dihydrate disease (CPPD). But first, let's look at a study out of Scotland, looking at military service and greater risk of hip and knee replacement.
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HHS, FDA & CDC Joint Recommendation on COVID Booster
Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.
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Tocilizumab in Refractory Skin and Joint Scleroderma
The interleukin-6 inhibitor, tocilizumab (TCZ), was studied in a cohort of difficult systemic sclerosis (SSc) and was shown to be effective in refractory joint and skin disease with good long-term retention rates and disease stabilization.
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Inflammatory Arthritis Impairs Male Fertility
A new study in Annals of Rheumatic Disease shows that inflammatory arthritis (IA) may impair male fertility, especially during the peak reproductive age when lower fertility rates, higher childlessness rates and more fertility problems were seen.
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ACR Update on Tocilizumab Shortages
The American College of Rheumatology (ACR) is actively engaged with the FDA Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra).
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