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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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colitis.jpg

TNF Inhibitor Induced IgA Vasculitis in IBD

d Jack Cush, MD

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

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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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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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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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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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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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Watch: Drs. Jack Cush, Kathryn Dao ( @KDAO2011) , Janet Pope ( @Janetbirdope) Eric Dein ( @ericdeinmd) and Yuz Yusof discuss a number of lupus presentations presented at the virtual EULAR 2021 meeting. #RheumNow https://t.co/yUEXTOatpR

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Tumor necrosis factor inhibitors (TNFi) are frequently used first line in rheumatoid arthritis (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. https://t.co/hmFZKrMdJ1 https://t.co/whCPvAAMMi

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Octave study examined COVID-19 Vax Ab responses in 600 immunocompromised-IMC (Cancer, IMID) pts. Compared to normals, fewer IMC seroconverted @4 wks (89 vs 100%). 40% of IMC had a low Ab resp; 11% of IMC had zero Ab response https://t.co/11VkeNKzvL

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Gut microbiome strongly influences irAE's in advanced melanoma pts taking checkpoint blockade targeting CTLA-4 and PD-1. Signatures for Bacteroides intestinalis & Intestinibacter bartlettii more grade 3+ irAE by inducing IL-1B https://t.co/rEHknJ3TSC

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