RheumNow Podcast – FDA Hyperactivity (7.26.19)

Jack Cush, MD

Jul 26, 2019 9:01 am

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

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
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
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
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
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
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
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
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
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
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
FDA AAC Splits Vote in Favor of Nintedanib for Scleroderma Interstitial Lung Disease
FDA Approves Apremilast for Behcet's Oral Ulcers
War on RA - Part 1: Walk on the Moon