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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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FDA, warning, side effect

FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors

d Jack Cush, MD

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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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

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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)

Lancet: 1276 Wuhan hosp COVID-19 pts studied at 6 & 12 mos. 68% & 49% had at least 1 COVID Sx at 6 & 12 mos. 12 mos sxs: SOB (30%), depression(26%), pain & mobility. Women had more fatigue/weak (OR 1.43), anx/depression (2·0), diffusion impairment (2·97) https://t.co/A8STTYiHq5 https://t.co/J4JoKFa00K

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Dr. John Cush RheumNow ( View Tweet)
The FDA announced its findings 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. https://t.co/jayl8ufPHn https://t.co/zNvPiVcdOM

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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/a7O1RC3Cph https://t.co/jMsuUM9lWy

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Dr. John Cush RheumNow ( View Tweet)
In 2018-2019 Australia spent $136 billion on healthcare with more spent on MSK disorders ($14 billion) than CV Dz ($11.8 billion), cancer ($11.8 billion) & mental Dz ($10.5 billion). CAD, back pain, dementia, COPD & lung cancer caused most $$ burden. https://t.co/WHIPeNGIhf

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Dr. John Cush RheumNow ( View Tweet)

Newly Revised Xeljanz Boxed Warning. New Changes highlighted in yellow. https://t.co/jayl8tYeiN https://t.co/5tXX00UgBD

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Dr. John Cush RheumNow ( View Tweet)
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)

Data from 4 parallel case-control studies within The Health Improvement Network looked at risk factors for developing PsA, psoriasis, RA, and AS showed both shared and differentiating risk factors, but statin use was protective in all 4 conditions. https://t.co/qXlpKVwwWg https://t.co/08jF5jPEH0

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Dr. John Cush RheumNow ( View Tweet)
Gout does occur with low SUA levels; Using data from ARIC, Framingham and CARDIA studies, the gout risk over 15 yrs was: SUA < 4 = 0.59% 4–4.49 = 1.28% 4.5–4.99 = 0.86% 5–5.49 = 0.94% 5.5–5.99 = 1.52% 6–6.49 = 2.91% 6.50–6.99 = 3.2% > 7.00 = 12.2% https://t.co/xm9iQrQT3U https://t.co/lVOTl18GK6

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Dr. John Cush RheumNow ( View Tweet)
Metanalysis of long-term steroid (GC) in PMR (24 studies) 77%, 51%, & 25% PMR pts still GC respectively 1, 2, & 5 yrs. 1st Yr pooled relapse rate =43%. Prolonged GC use/relapse moreso in Females, Hi ESR, periph arthritis, starting dose, tapering speed https://t.co/n0gGlik1hO https://t.co/WBqdfUW2RS

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Dr. John Cush RheumNow ( View Tweet)
Multi-center study of 215 pediatric SLE patients - 55%(118) w/ Hematologic findings: most common anemia (88), hemolytic anemia (4). Signif assoc w/ HEME dz: Renal Dz, low C3, APL Abs, anti-β2 GP1, Sm, LAC, high SLEDAI. Most Rx w/ steroids, IVIG or RTX https://t.co/nuD524kkD4 https://t.co/6a14bQ6SQ6

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Dr. John Cush RheumNow ( View Tweet)
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