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RheumNow Podcast – JAK Inhibitor Warnings from the FDA

d Jack Cush, MD

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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syringe,needle,vaccine

Not All Immunosuppression Alters Vaccine Immunogenicity

d Jack Cush, MD

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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JAK panel presentation FDA

Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors

d Jack Cush, MD

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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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

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Dr. John Cush RheumNow ( View Tweet)

ICYMI Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors https://t.co/omeZyprT96 https://t.co/UGBlb9m5bS

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)
New podcast available! Download wherever you get your podcasts. https://t.co/4jTBhYDzRn https://t.co/DUWVD89JJ5

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

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

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Dr. John Cush RheumNow ( View Tweet)
Not All Immunosuppression Alters Vaccine Immunogenicity https://t.co/I9sShpMLBO https://t.co/oz9Qp1HM1e

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

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

Links:

Dr. John Cush RheumNow ( View Tweet)
Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors https://t.co/omeZyprT96 https://t.co/zXlGpEK6cC

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

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

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

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

Links:

Dr. John Cush RheumNow ( View Tweet)

Steroid (GC) discontinuation from the BeSt and IMPROVED trials shows that w/ GC d/c 40% of RA pts Flare and 50-60% restart GC. Similar outcomes w/ 2nd attempt at GC d/c. Lower DAS28 scores had better odds of GC D/C. https://t.co/PtbgONNMwW

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Dr. John Cush RheumNow ( View Tweet)

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