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Abatacept Disappoints in Systemic Sclerosis

d Jack Cush, MD

A 12‐month, Phase 2 trial has shown that subcutaneous abatacept was well tolerated in patients with diffuse cutaneous systemic sclerosis (dcSSc), but failed to significantly change the skin outcomes as measured by the change in modified Rodnan skin score (mRSS)

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RheumNow Podcast – FDA Hyperactivity (7.26.19)

d Jack Cush, MD

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

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Tofacitinib Gets a New Boxed Warning for Blood Clots and Death with Higher Doses

d Jack Cush, MD

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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Efficacy of Maintaining or Switching to Baricitinib Monotherapy

d Jack Cush, MD

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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FDA will review to Genentechs application for Rituxan use in pediatric (age >2yrs) granulomatosis with polyangiitis & microscopic polyangiitis. If approved, this would be the 1st pediatric indication for RTX; data based on ths phase IIa PePRS study https://t.co/rRFiyQNKca

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Dr. John Cush RheumNow ( View Tweet)

Measures used to limit costs & utilization of expensive biologics: 1) Generics 1st requirement; 2) Pre-authorization; 3) limited (6-9 mos) approval w/ proof of benefit; 4) 30 day supply; 5) preferred tiered drugs; & 6) utilize less expensive providers https://t.co/2HRrJn87AY

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Dr. John Cush RheumNow ( View Tweet)

Testosterone replacement therapy Increases the risk of CV events (MI/CVA/TIA). Study of 15,401 men, >45 yrs old, w/ low testosterone & no evidence of hypogonadotropic or testicular dz (1995-2017). HR 1.21; CI 1.0-1.46), highest in the 1st 2yrs https://t.co/nNXyFIo1EH

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Dr. John Cush RheumNow ( View Tweet)

Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a negative opinion on Application for romosozumab (Evenity) for the treatment of severe osteoporosis (by Amgen & UCB); an appeal is planned https://t.co/EVjxuBQdF0

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Dr. John Cush RheumNow ( View Tweet)

Im starting a War on RA. I need you go get mad and do your part. Read 1st of 4 part series https://t.co/sR5Z3lq8CU or watch it here https://t.co/s7CVW2dNUT

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Dr. John Cush RheumNow ( View Tweet)

The FDA Arthritis Advisory Committee 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

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Dr. John Cush RheumNow ( View Tweet)

The RheumNow Podcast is up! News, Announcements of generics/biosimilars, approvals and FDA hearings. Watch the video here>> https://t.co/3tW7uRivgQ or listen to the podcast on iTunes>> https://t.co/q2bscJkIhs

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Dr. John Cush RheumNow ( View Tweet)

Image challenge: A 48-year-old man presented to the dermatology clinic with a 6-month history of painful hand ulcerations and shortness of breath. He has no muscle weakness or arthritis. What is the diagnosis? https://t.co/kQrNuVExlQ https://t.co/n3435OCPLA

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NEJM NEJM ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

Effect of Filgotinib in Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drugs - JAMA July 23/30 - Filgo (Jak1 inhib) efficacy in Bdmard-IR - selling point for Filgo = less Zoster, 300 pts for 6 mths 1.4% zoster in this study so watch this space

Peter Nash drpnash ( View Tweet)

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

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Angus Worthing MD AngusWorthing ( View Tweet)
The Assessment of Disease Activity in Psoriatic Arthritis: MDA, VLDA, DAPSA, or Something Else? https://t.co/jmyA5KABzM #diseaseactivity #remission #psoriaticarthritis

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The Journal of Rheumatology jrheum ( View Tweet)

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

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Dr. John Cush RheumNow ( View Tweet)

FDA puts a New Boxed Warning on #tofacitinib for Blood Clots and Death with Higher Doses (10 mg bid). https://t.co/Bzgst3ooo0

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Dr. John Cush RheumNow ( View Tweet)

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

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Dr. John Cush RheumNow ( View Tweet)

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

Links:

Dr. John Cush RheumNow ( View Tweet)

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