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Dr. Jack Cush reviews the news, journal reports, and FDA releases and deliberations covered this past week on RheumNow.com
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The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis.
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A post hoc analysis of baricitinib use in rheumatoid arthritis (RA) patients shows that while many patients respond well to baricitinib monotherapy or to switching to baricitinib monotherapy, those with less disease control respond well to the addition of methotrexate (MTX) to baricitinb.&nb
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The FDA convened Arthritis Advisory Committee to consider nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) and voted 10-7 in favor of approving the drug for this new indication.
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The FINCH2 study has shown that filgotinib, an oral once daily JAK 1 inhibitor, is highly effective in rheumatoid arthritis (RA) patients who failed to respond to prior biologic therapy.
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The comparative risk for gastrointestinal bleeding (GIB) with non-vitamin K antagonist oral anticoagulants (NOACs) was compared to vitamin K antagonists or anti-platelet agents in a recent metanalysis, which showed no significant difference in major GIB events between these agents.
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It’s a great time to be a rheumatologist and to manage RA. But, if you keep doing what you’re doing, you’re going to keep getting what you’ve got.
Angus Worthing MD
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A lot happening on reforms to curb high drug prices! Yesterday, @ChuckGrassley & @RonWyden's bill cleared Senate Finance Committee & I think there are positives and negatives. You can see @ACRheum letters to leaders on this & other issues @ this link:
https://t.co/AA8JrONPsa https://t.co/KnGHAXmRFE
The Journal of Rheumatology
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The Assessment of Disease Activity in Psoriatic Arthritis: MDA, VLDA, DAPSA, or Something Else? https://t.co/jmyA5KABzM #diseaseactivity #remission #psoriaticarthritis
Dr. John Cush
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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://t.co/nGgxZDBQyC
Dr. John Cush
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FDA puts a New Boxed Warning on #tofacitinib for Blood Clots and Death with Higher Doses (10 mg bid). https://t.co/Bzgst3ooo0
Dr. John Cush
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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://t.co/QpnIoltFEP
Dr. John Cush
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The FDA Arthritis Advisory Committee has voted 10-7 in favor of approving the to consider the antifibrotic drug, nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) https://t.co/UNlpQNJAim
Dr. John Cush
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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
Dr. John Cush
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FDA Arthritis Advisory Committee (AAC) and Drug Safety Committees are meeting today in Hyattsville to consider the approval of nintedanib (OFEV, made by BI), for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) https://t.co/z4uLJ8hdyX
Dr. John Cush
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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
Dr. John Cush
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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
Dr. John Cush
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Im starting a War on RA. I need you go get mad. Read it here https://t.co/sR5Z3lq8CU or watch it here https://t.co/s7CVW2dNUT
Dr. John Cush
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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
Dr. John Cush
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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
