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RheumNow Podcast – JAK Inhibitor Warnings from the FDA

Sep 02, 2021 11:41 pm

Dr Jack Cush reviews the news, journal articles and FDA warnings from the past week on

  1. 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)

  2. 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.

  3. 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.

  4. 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%

  5. 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

  6. 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)

  7. 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

  8. Not All Immunosuppression Alters Vaccine Immunogenicity

  9. 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

  10. JCI paper showing IgG fibromyalgia pts given to mice leads to passive transfer of FM symptoms leads to sensory hypersensitivity; increased sensitivity to noxious mechanical & cold stimulation, & nociceptive fibers in skin-nerve preparations.WHAT?

  11. TNF Inhibitor Induced IgA Vasculitis in IBD 

  12. FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors  

  13. Back TALK

The author has received compensation as an advisor or consultant on this subject

Rheumatologists’ Comments

William Davis

| Sep 09, 2021 8:40 am

What is the number needed to harm for JAKi and CV or cancer?

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