Thursday, 17 Oct 2019

You are here

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

  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. 
  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 
  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 
  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     
  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 
  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.
  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.
  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 
  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.
  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
  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 


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

Add new comment

More Like This

RheumNow Podcast – When You’re Hot You’re Hot (10.11.19)

Dr. Jack Cush delivers select commentary on select news and journal articles from the past week on

RheumNow Podcast – Women Take Over Rheumatology (10.4.19)

Dr. Jack Cush reviews the News and Journal Reports from this week on

Increasingly Women are Choosing Subspecialty Careers

JAMA Internal Medicine has an analysis of the growing trend of more women enrolling in medical schools in the last few decades, such that more than half of US Med school matriculants in 2017 were women.  Also in 2017, 42% of residents in internal medicine were women.  The reported analysis looked at internal medicine subspecialty choices by women and men between 1991 to 2016.


RheumNow Podcast – Cancer Risk in Systemic Sclerosis (9.27.19)

Dr. Jack Cush reviews the news and articles from the past week on

RheumNow Podcast – Believe in Vitamin D or Rituximab? (9.20.19)

Dr. Jack Cush reviews the news and journal articles from the past week on