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Pharma/Regulatory

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
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Visit the latest RheumNow Therapeutic Updates to learn more about earlier treatment with biologics to reduce the risk of organ damage in #Lupus #SponsoredbyGSKUSMA https://t.co/ZqWX0rlyfB https://t.co/IsDeUySaZd
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ACR Speaks Against Repeated Cuts to Medicare Reimbursements The ACR has submitted its comments to the CMS regarding the proposed CY 2025 Medicare Physician Fee Schedule and Quality Payment Program rule and its impact on rheums and rheum interprofessional team members’ ability to… https://t.co/cIjJwOWA5Z https://t.co/sPLZFUxywl
Dr. John Cush @RheumNow( View Tweet )
Consensus Guidelines on Pediatric Methotrexate Use MTX is commonly used in the treatment of pediatric inflammatory skin conditions, often for off-label indications. Consensus based recommendations were published to address 5 major subjects: -indications and contraindications… https://t.co/6JtIMGOAhq https://t.co/OZJLqAyOnF
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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/JpGqkHCznI https://t.co/t0bXPnfoCM
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ACR Recommends QOL Self-Management Strategies

ACR

American College of Rheumatology (ACR) experts identified research suggesting that patient self-management is

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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.

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Good Clinical Practice Recommendations on Glucocorticoid Withdrawal and Adrenal Insufficiency

Glucocorticoids are widely prescribed as anti-inflammatory and immunosuppressive agents. This results in at least 1% of the population using chronic glucocorticoid therapy being at risk for glucocorticoid-induced adrenal insufficiency. This risk is dependent on the dose, duration and potency of

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ACR Backs FDA Rule Change on Interchangeable Biosimilars

ACR

The American College of Rheumatology submitted comments to the U.S. Food & Drug Administration supporting their recent proposal to update the approval process for biosimilars’ interchangeability status by repealing the requirement for switching studies while also encouraging the FDA to

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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
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Less Mortality with GLP-1 Agonists in Rheumatic Patients

A recent article in PLOS ONE has shown that treatment of type 2 diabetes with glucagon-like peptide-1 receptor agonists (GLP-1-RAs) was associated with a significant lowering of risk of all-cause mortality and major adverse cardiovascular events in patients with immune-mediated inflammatory

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Anti-CD40 Therapy in Sjögren's Disease

Sjögren's disease is a chronic autoimmune condition without a clear effective therapy - DMARD or biologic. The TWINSS study has demonstrated the safety and efficacy of iscalimab, a monoclonal antibody against CD40, in a phase 2 randomized clinical trial of active Sjögren's disease (SD).

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Finding Spondylitis Among Psoriasis, Uveitis and Colitis Patients

Maksymowych and colleagues have shown that screening patients with either psoriasis, iritis, or colitis may yield a surprising percentage meeting ASAS criterial for axial spondyloarthritis (axSpA).

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FDA issued draft guidance, which, if implemented, would remove requirement for a switching study for demonstrating biosimilar interchangeability. Citing research showing no additional safety concerns if pts switched from reference biologics to biosimilars https://t.co/MBvI4yxajW https://t.co/sEE654E2rl
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Barriers to Treat-to-Target in Rheumatoid Arthritis

A systematic and scoping literature examined the Treat-to-target (T2T) approach to rheumatoid arthritis (RA), noting its implementation is suboptimal and finding many barriers to implementation.

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US News & World Report Top US Med Schools for Research Baylor Case Western Emory Hofstra Mayo Northwestern Ohio State UCLA UCSD UCSF U Cincinnati U Colorado U Pittsburgh UTSW Vanderbilt Yale https://t.co/VSEnBxWUF2 https://t.co/bGCBCD8npX
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Gout Forecast: 70% Increase by 2050

The Global Burden of Diseases, Injuries, and Risk Factors Study of 2021 has forecasted prevalence of gout to increase by 70% by 2050. In the USA, the prevalence of gout is estimated to be 10.3 million. As of 2020, 55.8 million people globally had gout, with a prevalence of 659.3 per 100 000 (

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CARRA Consensus Treatment for Refractory Juvenile Dermatomyositis

CARRA has developed consensus treatment plans for the use of biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with refractory, moderately severe juvenile dermatomyositis. Juvenile dermatomyositis is the most common form of idiopathic, inflammatory myositis in childhood, with

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Review of Calcium Pyrophosphate Deposition Disease

Lancet Rheumatology has published a review of Calcium pyrophosphate deposition (CPPD) disease - a chronic inflammatory and degenerative crystal arthropathy that increases with aging.

While the inflammatory response to calcium pyrophosphate (CPP) crystals may cause an acute or chronic

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In the UK, estimated cost of hardardous NSAID use is £31.43million (pounds) (£9.28m to £67.11m) over 10 yrs. High risk = Elderly >65y without gastroprotection, pts on anticoagulants; & Pts w/ heart failure, chronic kidney Dz , or Hx of peptic ulcer. https://t.co/bPXnQbQnNV https://t.co/aDLGHjLmhB
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Pain Reduction with Methotrexate in Knee Osteoarthritis

The Annals of Internal Medicine reports that oral, low dose, weekly methotrexate significantly reduced knee osteoarthritis (KOA) pain, stiffness, and function in a randomized controlled trial.

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PEXIVAS: Diffuse Alveolar Hemorrhage in ANCA-Associated Vasculitis Patients

A secondary analysis of the PEXIVAS study showed antineutrophil cytoplasmic antibody–associated vasculitis (AAV) patients complicated by diffuse alveolar hemorrhage (DAH) may have improved with plasma exchange and glucocorticoids, the results did not achieve significance. 

Diffuse

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Drug Safety Update, from UK MHRA, shows impt interaction between tramadol and warfarin. Tramadol may increase the INR with risk of major bruising and bleeding when warfarin and tramadol are taken concomitantly. https://t.co/mgmeMJzdLa

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Digital Self Screening for Arthritis Diagnosis

There are numerous impediments to diagnosis or referral; and a new study evaluates patient use of a mobile artificial intelligence (AI)–based symptom checker for diagnoses, but demonstrated only modest accuracy when applied to a cohort of patients with joint symptoms.

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Earlier RA Diagnosis Leads to Lower Costs of Care

A study from the Leiden Early Arthritis Clinic shows that is rheumatoid arthritis (RA) is diagnosed within 12 weeks after symptom onset, treatment costs were lower in both autoantibody-negative and autoantibody-positive RA. 

The rheumatologist

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