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EMA Crack Down on JAK Inhibitors

Jack Cush, MD

The European Medicines Agency’s (EMA's) safety committee (PRAC) has issued a recommendation that the use of oral JAK inhibitors (tofacitinib, baricitinib, upadacitinib and filgotinib) be limited to certain at-risk patients unless no other suitable treatment alternatives are available.

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Infections & Lupus (10.28.2022)

Jack Cush, MD

Dr. Jack Cush discusses the news and journal reports from the past week on RheumNow. This week more lupus nephritis, more drug induced lupus and more lupus infections that may kill. 

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Update to Axial Spondyloarthritis Guidance

MedPage Today

EULAR and the Assessment of SpondyloArthritis International Society (ASAS) has updated their guidance on axial spondyloarthritis (axSpA) management.

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FDA Approves Upadacitinib for Non-Radiographic Axial Spondyloarthritis

Jack Cush, MD

On Friday October 21st the U.S. Food and Drug Administration approved upadacitinib (Rinvoq) for the treatment of active non-radiographic axial spondyloarthritis in patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor blocker therapy.

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ACR Award Winners (10.21.2022)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. Highlighted discussion of implantable stimulators, urine proteomics and gut-immune responses to Prevotella in RA.

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No Special Heart Risk With JAK Inhibitors, Study Finds

MedPage Today

Patients taking Janus kinase (JAK) inhibitors for rheumatoid arthritis experienced similar cardiovascular outcomes as those using the tumor necrosis factor (TNF) blocker adalimumab (Humira), analysis of French national registry data indicated.

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🆕Recommendation provided by Pharmacovigilance Risk Assessment Committee (#PRAC) about Janus kinase inhibitors #JAKi ⏩EMA recommends measures to minimise risk of serious side effects with #JAKi for chronic inflammatory disorders. https://t.co/YqaX7UxtUA https://t.co/dCJbqanAxF

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Renaud Felten DocFelten ( View Tweet)
Celebrating my 10,000 followers on TikTok. @Rheum101 is where I make videos teaching rheumatology to the general public in 3 min bites. Topics include #SLE #Steroids #RA #ANA #RheumLabs #DMARDS #biologics #JAKi #osteoporosis #PsA and more #RheumEducation #NotMedicalAdvice https://t.co/WEXspp5v28
TheDaoIndex KDAO2011 ( View Tweet)
Will we see you there? #ACR2022 What are you most looking forward to on the agenda? https://t.co/KQGHJtwboe
Dr. John Cush RheumNow ( View Tweet)
Listen to the FDA Drug Safety Podcast (for HCPs). On the Risk of Serious Adverse events with JAK Inhibitors (based on their HCP safety alert from 9/21/2021). 4 min long, basic info, not alot of depth...but its from the FDA. https://t.co/0Hns5bDU2A https://t.co/mRKi8NEKGW

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Dr. John Cush RheumNow ( View Tweet)
FDA has approves RINVOQ (upadacitinib) for the treatment of Active Non-Radiographic Axial Spondyloarthritis https://t.co/DMuQFjFdrf https://t.co/zLsniZ2zOg

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Dr. John Cush RheumNow ( View Tweet)
Follow us for real time coverage #ACR2022 https://t.co/5CBdiKWdKM
Dr. John Cush RheumNow ( View Tweet)
EMA CHMP issued a positive opinion on the safety of Filgotinib, a selective JAK1 inhibitor, based on testicular safety data from the MANTA & MANTA-RAy studies. Gilead withdrew filgotinib from US market w/ FDA concerns on testicular safety in 12/20 https://t.co/38xOWb1zJi https://t.co/jPUy6H1QQN

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Dr. John Cush RheumNow ( View Tweet)
No Special Heart Risk With JAK Inhibitors, Study Finds Patients taking JAK inhibitors for RA experienced similar cardiovascular outcomes as those using the TNF blocker adalimumab (Humira), analysis of French national registry data indicated. https://t.co/Ai3xTPcoO8 https://t.co/TuMaQMWepj

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Dr. John Cush RheumNow ( View Tweet)
Rheumatology Salaries and Career Choices A recent Doximity report shows how rheumatology salaries increase by years in practice. Rheumatologists tend to earn their highest salaries after gaining 30-39 years of experience. https://t.co/wxWQruIlu9 https://t.co/gUsIffoHn6

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Dr. John Cush RheumNow ( View Tweet)
Record a Question or Comment... Rheums: Have a Rheumatology question or case for Jack Cush? Record it here and we'll feature it on an upcoming podcast. Tell us your name and where you practice rheumatology. https://t.co/rICbSJzPbk https://t.co/VIjlR6xlwQ

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Dr. John Cush RheumNow ( View Tweet)
Tofacitinib shows promise in scleroderma https://t.co/6qUGLlztBd https://t.co/Mk2x2HAkiO

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Dr. John Cush RheumNow ( View Tweet)
Tofacitinib in 15 pts w/ early diffuse skin Scleroderma. Tofa downregulated STAT3 (macrophages, DCs) & IFN (fibroblasts) & MYOC/CCL19 (adventitial fibroblasts); well tolerated & trend to improved mRSS scores (ns) https://t.co/givh5j3m9z https://t.co/ms97tvQy5e

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Dr. John Cush RheumNow ( View Tweet)
Comprehensive full-read review of #Baricitinib trials in treating COVID-19. 24 studies (16 retrospective, 5 prospective, 3 case control) studies & 3 larged RCTs show Bari as 24-38% better than comparators/SOC (few showed no change in mortality) https://t.co/2svMMX4wDw https://t.co/zoSGGZJYui

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Dr. John Cush RheumNow ( View Tweet)
2 open-label reports of JAK inhibitors in Systemic sclerosis (SSc) - 59 SSc pts: significant decr in mRSS in 88%. 28/29 w/ ILD had no progression. Overall responses better in treatment naïve SSc patients. 20% had side-effects. More studies needed https://t.co/sR2OMNtxAk https://t.co/qOdMEZheFz

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Dr. John Cush RheumNow ( View Tweet)
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