Tuesday, 22 Oct 2019

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The RheumNow Week in Review – FDA Showdown for Baricitinib (4.27.18)

Dr. Jack Cush reviews the news and FDA proceedings from the past week on RheumNow.com.

  1. UCSF study of 807 lupus pts shows that poverty is associated with a 2 fold increased risk of mortality in SLE pts, does so by increasing the extent of damage accumulation. Poor who died lived 13.9 fewer years. https://t.co/kGEnsuP2il
  2. A large CV prevention trial found 722 new gout cases among 12,866 men (age 35–57). Chronic kidney dz assoc w/ a 61% incr risk of gout (HR 1.61), increased w/ proteinuria & hematuria, but not by serum urate https://t.co/DOUBaACaM6
  3. Among 2619 RA patients, use of hydroxychloroquine (n 1212) was associated with a lower risk of CKD (10.3 vs 13.8 per 1000PY); thus HCQ assoc w/ a lower risk of incident CKD (HZ 0.64; 95% confidence interval, 0.45 to 0.90; P=0.01) & was dose dependent https://t.co/MaTsZEDBKG
  4. Study of 537 GCA pts undergoing temporal artery bx shows the value of CBC elements in predicting a +Bx: Thrombocytosis (OR 4.44), NLR (OR 1.81), PLR (OR 3.25), CRP (OR 3.00), ESR (OR 3.62), increased age (OR 1.03) https://t.co/3XvzBR5cEh   
  5. FDA Arthritis advisory panel voting in progress. Early votes unanimously in favor of baricitinib efficacy at 4 mg (15-0) or 2mg(14-1 unfavorably)
  6. FDA Arthritis advisory panel voting on baricitinib safety was 9-6 in favor of 2mg and was 11-4 against the safety of 4 mg 
  7. FDA Arthritis panel on Baricitinib approval in RA votes 10-5 in favor of 2 mg dose but voted 10-5 Against baricitinib 4 mg dose. Concerns about safety of 4 mg dose, esp VTE, thrombophilia 
  8. FDA Arthritis Panel Split on the Efficacy and Safety of Baricitinib in RA  
Disclosures: 
The author has an ownership interest in this subject

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