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FDA decision explained on why they modified its rule on #Biosimilar interchangeability. Approved 15 yrs ago, now there are 50 Biosimilars in USA. Switching (interchangeability) studies are no longer needed based on the FDA experience over last 8 years. https://t.co/vpmgdVeDwz https://t.co/UAWnFQxugl
Dr. John Cush RheumNow ( View Tweet)
Fasenra (benralizumab, an anti-IL-5 mAb) has been FDA approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA); approval based on MANDARA trial - H2H noninferior to mepolizumab at remission https://t.co/5tAPolUItK https://t.co/VHCNjACThw
Dr. John Cush RheumNow ( View Tweet)
FOREMOST: Apremilast in Early Oligoarticular Psoriatic Arthritis
A controlled trial has shown that apremilast is effective in patients with early, oligoarticular psoriatic arthritis (PsA).
https://t.co/i2w4RbGd5f https://t.co/5PD6pYB5vm
Dr. John Cush RheumNow ( View Tweet)
Metanalysis of JAKi in ILD (7 studies, 183 pts) showed increases in FVC (2 %), DLCO (3.1%) & improved Thoracic HRCT of 11%; only 5% had worsening of their ILD. Risk of ILD w/ JAKi was low ( 0.20/1000 PY) w rates similar to abatacept & rituximab https://t.co/UDJ1ZvtGhh https://t.co/WTQS67yDyl
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Dr. John Cush RheumNow ( View Tweet)
I Can't Treat Ugly (9.20.2024)
Dr. Jack Cush reviews the news, journal articles and a new FDA approval for EGPA, this week on the Podcast.
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Pipeline drugs and trials intended for Interstitial Lung Disease - including studies with nintedinib, Efzofitimod, BI 1015550, AD-214, Abatacept, ATYR1923, Pirfenidone inhalation, RO-0220912, Lung stem cells...Riociguat, Treprostinil and more https://t.co/fpMjjubPVx https://t.co/ketFP0N9jk
Dr. John Cush RheumNow ( View Tweet)
Yes you can space out Guselkumab injx in controlled Psoriasis. Phase 3b RCT of 149 GUS pts w/ PASI <4 were cont on GUS q8 wks or spaced to q16wks. Noninferiority was shown w/ maintenance of "super-responders" in > 90% w/ both https://t.co/4Y9quetoJn https://t.co/zP9ywFKpvY
Dr. John Cush RheumNow ( View Tweet)
Voclosporin and Steroids in Lupus Nephritis
Dr. Jack Cush reports on abstract OP0059 presented at Eular 2024 in Vienna, Austria.
https://t.co/4CilABzEjm https://t.co/hgyDqG1fPR
Dr. John Cush RheumNow ( View Tweet)
So You've Got RA and Want to Get Pregnant?
Dr. David Liew reviews abstract POS0436 presented at Eular 2024 in Vienna, Austria.
https://t.co/vG9l7kOReq https://t.co/xhumOCisOM
Dr. John Cush RheumNow ( View Tweet)
Chinese study of 62 Systemic JIA pts Rx w/ IV Tocilizumab (34 12 mg/kg; 28 8 mg/kg). Wk12 87% responded (JIA ACR 30w/ no fever); Week 52 results were similar. No deaths or macrophage activation syndrome occurred. https://t.co/qGgMCt597x https://t.co/lFDxAgDHfW
Dr. John Cush RheumNow ( View Tweet)
BSR Guidelines for Systemic Sclerosis Management
The British Society for Rheumatology (BSR) has updated its 2015 guidelines for the management of patients with sytemic sclerosis (SSc) based on published evidence, systematic literature review and expert opinion.
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CAR-T Like Effects with Bispecific Teclistamab
A new chapter may have begun in the exciting story of "immune reset" therapy for difficult-to-treat autoimmune diseases, with a patient with severe refractory lupus obtaining drug-free remission after treatment with an antibody… https://t.co/FO42QaJaFn https://t.co/5LouAzYeOv
Dr. John Cush RheumNow ( View Tweet)
Guselkumab (Tremfy) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, based on pivotal, Phase 2b/3 QUASAR study showing 50% remission at week 44 (vs 19 PBO) for those on GUS 200 mg q 4 wk https://t.co/YgtujQjNqI https://t.co/9uazZLuoRb
Dr. John Cush RheumNow ( View Tweet)
Moving Forward on RA Prevention Trials
Now that multiple prevention clinical trials for rheumatoid arthritis (RA) have been completed, a group of investigators have reviewed the results and published their recommendations for future trial designs and drug development to assess… https://t.co/ppmWa27tgd https://t.co/lQEtBNRZRm
Dr. John Cush RheumNow ( View Tweet)
Low Placental Transfer Rates with Risankizumab
There are significant concerns about the safety of drug use during pregnancy and lactation, especially newer biologic agents. This is complicated by a lack of research.
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PsA: Switch or Cycle, the Eternal Question
Dr. Aurelie Najm reports on abstracts POS0278 and POS0266 presented at Eular 2024 in Vienna, Austria.
https://t.co/xP65pw5zCw https://t.co/T0nBO3HMIP
Dr. John Cush RheumNow ( View Tweet)
Linger on the Fingers (9.6.2024)
Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow. This week with a focus on fingers and better prescriptive follow through.
https://t.co/c9yvRjE9av https://t.co/mdN37AWHjX
Dr. John Cush RheumNow ( View Tweet)
Moving Forward on RA Prevention Trials
Now that multiple prevention clinical trials for rheumatoid arthritis (RA) have been completed, a group of investigators have reviewed the results and published their recommendations for future trial designs and drug development to assess interventions that may alter disease development.
Read Article
CAR-T Like Effects with Bispecific Teclistamab
A new chapter may have begun in the exciting story of "immune reset" therapy for difficult-to-treat autoimmune diseases, with a patient with severe refractory lupus obtaining drug-free remission after treatment with an antibody… https://t.co/uE7QEHc0nx https://t.co/UcenZHv35O
Dr. John Cush RheumNow ( View Tweet)
Dactylitis is seen in 50% of PsA patients. Dactylitis is frequently associated with more severe PsA phenotype, often representing the initial feature of the disease. Many agents are effective but no b/tsDMARD is distinguished as being superior in dactylitis.… https://t.co/NKOXReiZYd https://t.co/Ake2fixZ40
Dr. John Cush RheumNow ( View Tweet)