Friday, 23 Aug 2019

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RheumNow Podcast – FDA Hyperactivity (7.26.19)

Dr. Jack Cush reviews the news, journal reports, and FDA releases and deliberations covered this past week on RheumNow.com

  1. EUSTAR Study had 1451 systemic sclerosis (SSc) pts enrolled & 706 had complete data. Predictors of #SSc worsening included age, active digital ulcers, lung fibrosis, muscle weakness and elevated C-reactive protein level. https://t.co/QepC6I0HLm 
  2. 18 mos study of 78 patients with ANCA Assoc Vasculitis showed baseline IL-6 levels correlate with PR3-ANCA (not MPO) titers; while assoc w/ certain Sxs (fever, pulm nodules/cavities), deafness, RBC casts; sIL6 levels did not predict responses at 6 mos https://t.co/jawVLOSQnZ 
  3. Dannish MRI study of 204 people (including 41 #AxSpA) shows that sacroiliac bone marrow edema is nonspecific, seen in 3-39% of non-SpA. Only SI erosions erosions, backfill & ankylosis were specific for axSpA. Few women w/ postpartum pain had SI erosion https://t.co/7iMaKGEafJ 
  4. Weight loss does not reduce #RA risk. Swedish Obese (SOS) study followed 2002 bariatric surgery pts & 2034 controls. Overall 92 developed RA; RA risk now lower w/ bariatric surgery (HR 0.92; CI 0.59, 1.46) nor did wt loss; but CRP & smoking were https://t.co/bFKiPWvKRQ     
  5. FDA warning about meds that may impair driving (car, bus, train, plane, or boat) - Especially opioids, benzodiazepines, antidepressants, muscle relaxants, sleep meds, motion sickness & diet pills, ADD or “stay awake” drugs https://t.co/P08wvds0GK 
  6. FDA has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to Rituxan for use in NHL, CLL, granulomatosis w/ polyangiitis (GPA) & microscopic polyangiitis;(NOT RA) THis is the 2nd RTX biosimilar. https://t.co/GuVG6S980j
  7. FDA has approved a new biosimilar Hadlima (adalimumab-bwwd), from Samsung Bioepis, for the same indications as Humira (RA, pJIA, PsA, AS, Crohn’s, UC, plaque psoriasis), but the drug won't be available in the U.S. until June 2023. https://t.co/h4oqwFjR0c
  8. FDA has approved generic febuxostat 40 mg & 80 mg tabs, for gout - to be made by Read more at Business Medical Dialogues: Alembic Pharma gets USFDA nod for generic version of Uloric tablets https://buff.ly/2y6EKA6 
  9. FDA approves generic pregabalin (Lyrica) - for the management of fibromyalgia, neuropathic pain in diabetic neuropathy, and for postherpetic neuralgia or partial onset seizures & neuropathic pain associated with spinal cord injury. https://t.co/Jg5q7LLjT2
  10. In the EU Samsung Bioepsis has announced an update to the EU product label for its adalimumab biosimilar IMRALDI - adding the drug can be stored in non-refrigerated conditions (up to 25˚C or 77F) for up to 28 days  https://buff.ly/2Yljy3T
  11. FDA AAC Splits Vote in Favor of Nintedanib for Scleroderma Interstitial Lung Disease   
  12. FDA Approves Apremilast for Behcet's Oral Ulcers 
  13.  War on RA - Part 1: Walk on the Moon 

 

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

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