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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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Chronic inflammatory disease (CID) patients are urged to receive the COVID-19 vaccines; but when a cohort of CID patients treated with immunosuppressive medications were given an mRNA-based SARS-CoV-2 vaccination, only those treated with glucocorticoids and B cell depleting therapies (B
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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.
Dr. John Cush
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Do you subscribe to our weekly podcast? It’s available wherever you download your podcasts—just search RheumNow. And, of course, find it on the site each Friday!
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Dr. John Cush
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ICYMI:
Using inpatient hospital records of 1.9 million SLE pts, the mortality of hospitalized #SLE changed little from 2006-2016;mortality dropped from 2.2% to 1.5% - with most of this decline between 2006-‘08 and no change since. Racial disparities seen. https://t.co/UUsJYFxQS4
Dr. John Cush
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ICYMI
Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors
https://t.co/omeZyprT96 https://t.co/UGBlb9m5bS
Dr. John Cush
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Highly allergic can safely get the COVID Vax. Israeli study of 8102 pts w/ allergies recv Pfizer mRNA vax - 429 were highly allergic-->98% of the highly allergic had no allergic rxns, 1% mild allergic resp & 3 anaphylactic rxns Rx w/ EPI, none hospitalized https://t.co/ATYs5R5AQC https://t.co/owNEACH1pe
Dr. John Cush
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New podcast available! Download wherever you get your podcasts.
https://t.co/4jTBhYDzRn https://t.co/DUWVD89JJ5
Dr. John Cush
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ICYMI:
FDA slaps new BOXED warning revision on ALL JAK inhibitors (Xeljanz, Olumiant, Rinvoq) after final revew of the Pfizer Oral Surveillance study. New warnings for incr risk of MI, CVA, VTE, lymphoma & death see w/ BOTH dose of tofacitinib. https://t.co/tvTv40oy59
Dr. John Cush
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500 Turkish pts from 4 pediatric rheum clinics. Oligoart. JIA (oJIA) was most common (39%), then enthesitisJIA (ERA-23%), RF neg polyarthritis (16%), RF+ poly (2.2%), Systemic JIA (16%), juvenile PsA (5.2%). Uveitis most common in oJIA (13%), then ERA (5%) https://t.co/a7O1RBM1xJ https://t.co/woSafvVsmA
Dr. John Cush
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Not All Immunosuppression Alters Vaccine Immunogenicity
https://t.co/I9sShpMLBO https://t.co/oz9Qp1HM1e
Dr. John Cush
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FDA JAKi Warnings, 2nd Panel of rheumatologists weigh in on this. Drs. Cush, Dao, Tate, Sparks, Shergy. https://t.co/0WqeV6jKex via @YouTube #RheumNow @KDAO2011 @uptoTate @jeffsparks @WilliamShergy
Dr. John Cush
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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.
https://t.co/4jTBhYDzRn https://t.co/lMpl2IOeXe
Dr. John Cush
Tweet
Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors
https://t.co/omeZyprT96 https://t.co/zXlGpEK6cC
Dr. John Cush
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FORWARD prospective registry showed Obesity to be associated with a substantially higher risk of incident chronic opioid use (HR adj 1.74). Approximately 1 in 4 cases of incident strong opioid use can be attributable to obesity ((HRadj 2.11) https://t.co/R0KhH4b05g https://t.co/HGHeqh4B0c
Dr. John Cush
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PhIII trial of Baricitinib vs placebo in hospitalized COVID-19 pts (91% steroids, 13% remdesivir). While no diff (28 vs 30%) in primary outcome (O2, ventilation, death). BARI had signif better Mortality @28d (8 vs 13%) & 60d (10 vs 15%) w/ no incr in VTE https://t.co/AjoRgEKW8G
Dr. John Cush
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Highly allergic can safely get the COVID Vax. Israeli study of 8102 pts w/ allergies recv Pfizer mRNA vax - 429 were highly allergic-->98% of the highly allergic had no allergic rxns, 1% mild allergic resp & 3 anaphylactic rxns Rx w/ EPI, none hospitalized https://t.co/ATYs5R5AQC https://t.co/RoYU2vVLl2
Dr. John Cush
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Did you know that we have large library of downloads available for use in education? Head to RheumNow and download today.
https://t.co/CEbS8eDs1j https://t.co/VTJWYUrm8U
Dr. John Cush
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I need to correct this tweet. there have NOT YET Been any changes to the PI for Xeljanz. What is highlighted here is the language prior to yesterdays FDA action. The Companies will have to work w/ FDA on changing the boxed warning. My Mistake! https://t.co/ymp1MMiLOd
Dr. John Cush
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Using inpatient hospital records of 1.9 million SLE pts, the mortality of hospitalized #SLE changed little from 2006-2016; mortality dropped from 2.2% to 1.5% - with most of this decline between 2006-2008 and no change since. Racial disparities seen. https://t.co/UUsJYFxQS4
