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ACR Backs FDA Rule Change on Interchangeable Biosimilars
The ACR submitted comments to the FDA supporting their proposal to update the approval process for biosimilars’ interchangeability status.
https://t.co/YD11qZJxIr https://t.co/tVij0ebwz4
Dr. John Cush RheumNow ( View Tweet)
New $$$ drugs are NOT usually steroid sparing, but a single center 716 RA pt study compared JAKi (n 156) vs bDMARDs (560) starts; JAKi assoc w/ more rapid GC reduction in1st 6 mos & 60% higher odds of GC D/C (adj OR 1.63) (>50% vs 40% @12 mos) https://t.co/shiDytQeBU https://t.co/dCjyw21uLd
Dr. John Cush RheumNow ( View Tweet)
Sequential Belimumab and RTX in SLE
Could disease control in active SLE patients be improved by the sequential use of subcutaneous BEL and intravenous RTX? A double blind trial has shown that sequential BEL and RTX was not superior to BEL alone in SLE.
https://t.co/CO0ltRX9Eo https://t.co/zey2UE4BRu
Dr. John Cush RheumNow ( View Tweet)
Retrospective study of 919 RTX-treated GPA pts shows TMP-SMX prophylaxis (given to 31%) assoc w/ reduced serious infections (adj HR 0.5) and less outpatient infections (aHR 0.8). All 13 pneumocystis infx (PJP) occured in those not Rx w/ TMP-SMX. https://t.co/bO6oAHv7Lr https://t.co/fPntW75hnY
Dr. John Cush RheumNow ( View Tweet)
AR882, a URAT1 inhibitor, was given FDA Fast Track designation for potential treatment of clinically visible tophi in patients with gout. In the US 13 mill have gout & 2 mill have visible tophi. AR882 was presented at EULAR24 https://t.co/StvD3iz9AD https://t.co/G9SzxJysSD https://t.co/KcUSPVb5pn
Links:
Dr. John Cush RheumNow ( View Tweet)
AR882, a URAT1 inhibitor, was given FDA Fast Track designation for potential treatment of clinically visible tophi in patients with gout. In the US 13 mill have gout & 2 mill have visible tophi. AR882 was presented at EULAR24 https://t.co/StvD3iz9AD https://t.co/G9SzxJysSD https://t.co/KcUSPVb5pn
Dr. John Cush RheumNow ( View Tweet)
All in the Family (8.23.2024)
Dr. Jack Cush picks highlight reports from the past week on RheumNow.com, with reports on the challenge of lupus nephritis, perplexing skin issues, you don't know JAK (about Tyk) and the value of a good family history.
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2024 Update of EULAR recommendations for the Treatment of Systemic Sclerosis
https://t.co/52XEfgVCzZ https://t.co/d1zgTYUeOo
Dr. John Cush RheumNow ( View Tweet)
Tyk2 inhibitor/Zasocitinib (TAK-279) effective in Psoriasis. Ph II RDBPCT of 259 pts w/ mod- severe plaque PsO showed 12 week PASI 75 success in 68% & 67% on 15 - 30 mg zasocitinib qd vs Placebo (18%). https://t.co/yyZwBYAP3H https://t.co/TvSSlEAKtR
Dr. John Cush RheumNow ( View Tweet)
Biologic Rx may be less effective in psoriasis pts who are older, smokers, w/ Hi BMI & prior biologic use. Metanalysis of 40 studies, 21 438 PSO pts, and PASI90 responses. Decr Response w/ age (OR 0.99), Biologics (0.44), BMI 30+ (0.57), smoking (0.81) https://t.co/uhFFIwNKB7 https://t.co/LaznQ0M9UG
Dr. John Cush RheumNow ( View Tweet)
Pulse Steroids with Tocilizumab in Giant Cell Arteritis
A pilot study assessed pulse methoprednisolone with weekly subcutaneous TCZ in patients with large vessel-GCA (LV-GCA) and showed that a sizeable minority will relapse after the TCZ is discontinued.
https://t.co/gGrSY3U1t9 https://t.co/zuspadaY9t
Dr. John Cush RheumNow ( View Tweet)
ACR Applauds Lower Negotiated Prices for Common Arthritis Drugs
The ACR praised the recent announcement from the CMS that their initial drug pricing negotiations have reduced costs for select medications, including significantly lower prices for Enbrel and Stelara, which are… https://t.co/GXl6y87ZaF https://t.co/A2N4Ehg8Dk
Dr. John Cush RheumNow ( View Tweet)
Severe Alopecia Areata or Universalis - if you stop the JAK inhibitor, Hair loss occurs quickly, but can be recaptured. Severe Alopecia Areata. Substudy of the baricitinib BRAVE-AA1 RCT, 80% of those who D/C vs 8% of those continuing, lost BARI benefits https://t.co/YcfmegdvK6 https://t.co/GIwVy4ac6U
Dr. John Cush RheumNow ( View Tweet)
Global Biologics Market size is valued at USD 408.5 billion in 2023 and is projected to grow ~8.25% annually. https://t.co/2RTHIgJOP5 https://t.co/gfndut5wc0
Dr. John Cush RheumNow ( View Tweet)
Sequential Belimumab and Rituximab in SLE
Could disease control in active systemic lupus erythematosus (SLE) patients be improved by the sequential use of subcutaneous belimumab (BEL) and intravenous rituximab (RTX)? A double blind trial has shown that sequential BEL and RTX was not superior to BEL alone in SLE.
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ASLeap: Higher Dose Secukinumab in Ankylosing Spondylitis
Ankylosing spondylitis (AS) patients not responding to usual dosing with secukinumab (150 mg) after 16 weeks were dose escalated to SEC 300 mg, but failed to show improvement by week 52.
https://t.co/EJvoBlW9or https://t.co/tYb1fIA3pw
Dr. John Cush RheumNow ( View Tweet)
Anti-CD40 Therapy in Sjögren's Disease
Iscalimab, a CD40 monoclonal antibody, showed + results in treating Sjögren's disease, an autoimmune condition lacking effective therapy. The TWINSS study demonstrated iscalimab's safety/efficacy in a phase 2 trial.
https://t.co/aanI9K83XP https://t.co/qJhgHDFCVY
Dr. John Cush RheumNow ( View Tweet)
ACR Applauds Lower Negotiated Prices for Common Arthritis Drugs
The American College of Rheumatology praised the recent announcement from the Centers for Medicare & Medicaid Services (CMS) that their initial drug pricing negotiations have reduced costs for select medications, including significantly lower prices for Enbrel and Stelara, which are frequently used to treat rheumatic diseases.
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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/GV6WjsqZBH https://t.co/9l9qyJpg3I
Dr. John Cush RheumNow ( View Tweet)
Among the 1st 10 drug prices Negotiated by Medicare - Two are for Rheums:
- Etanercept; original price $7,106/Mo], negotiated price $2,355 (67% decr)
- Ustekinumab: for original price $13,836/mo, negotiated price $4,695 (66% decr) https://t.co/eexr4Acrbi https://t.co/fE0aoD8vA3
Dr. John Cush RheumNow ( View Tweet)