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Pharma/Regulatory

NEJM: Aortitis Due to Large-Vessel Vasculitis 63yoM w/ Hx HTN c/o 3 mos of CP, palpitations, abdominal pain. ESR-104, CRP 85 mg/L. CT showed thickening of the thoracic & abdominal aorta. After 6wks Rx w/ AZA, HCQ, Pred, ESR/CRP still high and pt stared on SC TCZ w/ improvement. https://t.co/1TBreptAFr
Dr. John Cush @RheumNow( View Tweet )
FDA has announced "Breakthrough Designation" for 3 drugs + 1 test being developed: ** Biogen: litifilimab (targets dendritic cells) for cutaneous lupus ** Novartis: Ianalumab (BAFF blockade) for Sjogrens ** J&J: Nipocaiimab (FcRn) for Sjogrens ** Encarta: pocket Lyme test https://t.co/RMKg14rejq
Dr. John Cush @RheumNow( View Tweet )
Study shows half of FL autonomous nurse practitioners practicing outside their scope of practice. FL law allows autonomous NPs in primary care w/ 3K practice hrs. 194/328 NPs working in non-primary care: cosmetics, antiaging, IV hydration, vitamin infusions, hormonal Rx, https://t.co/WMksEb0Uyc
Dr. John Cush @RheumNow( View Tweet )

ANA Pollution (2.06.2026)

Dr. Jack Cush reviews the news, journal articles and regulatory news from this past week on RheumNow.com

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FDA sent a complete response letter to AstraZeneca on their application (BLA) for anifrolumabs (Saphnelo) subcutaneous use in SLE. Despite a positive TULIP-SC trial & EU approval of SC-anifrolumab, FDA & sponsor still have to work things out. CRL reasons are unknown https://t.co/3dNwEyolrj
Dr. John Cush @RheumNow( View Tweet )

FDA vs. Amgen: At Odds Over Avacopan

MedPage Today

The FDA has requested that Amgen voluntarily withdraw avacopan (Tavneos), a treatment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, but the company said it has no plans to pull the drug from the market.

Originally developed by ChemoCentryx, the oral

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ACR Applauds Recent Government Funding

ACR

The American College of Rheumatology (ACR) today applauded the recent passage of the Congressional CY 26 funding package that includes several important provisions, including extending Medicare telehealth payment flexibilities, improving transparency in pharmacy benefit management (PBM)

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SGLT2 Inhibitors in Gout - Better Outcomes, Fewer Meds Natalie McCormick, PhD (RACER Center, Mass General Brigham), led a new Diabetes Care study on gout-related medication use after starting SGLT2 inhibitors in patients with gout and type 2 diabetes. https://t.co/P3zoTbPvoO https://t.co/SZxI9sX4av
Dr. John Cush @RheumNow( View Tweet )

ALTO: Long-Term Abatacept Outcomes in At-Risk RA

Lancet Rheumatology has published the ALTO results - long term outcomes of the APIPPRA trial, demonstrating that treatment with abatacept (ABA) in at risk patients can delay progression to rheumatoid arthritis (RA) for up to 4 years.

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Retractions in Rheumatology Retractions in rheumatology are rising. An analysis of Retraction Watch data found 381 retracted articles (1989–2024), driven by misconduct or data errors. 68.5% originated in Asia, over half from China (50.7%). https://t.co/I6WmceNi2m https://t.co/6z0jHPaiaR
Dr. John Cush @RheumNow( View Tweet )
DMARD Responses in Localized Scleroderma JAMA Dermatology has published the results of a juvenile localized scleroderma (JLS) trial showing that mycophenolate mofetil (MMF) and methotrexate (MTX) are equally effective in treating JLS, noting low flare rates and possibly better https://t.co/NIR0ejs1RL
Dr. John Cush @RheumNow( View Tweet )
Potential New Rheumatology Drugs for 2026. These have had successful phase III RCTs and will need to be reviewed by regulators: ** deucravacitinib (Sotyktu) Tyk2 inhib for PsA ** Icotrokinra (Icotyde) oral IL-23i for psoriasis ** brepocitinib TYK2/JAK1 inhibitor for https://t.co/CQmfjIDMp3
Dr. John Cush @RheumNow( View Tweet )
NEJM: Aortitis Due to Large-Vessel Vasculitis 63yoM w/ Hx HTN c/o 3 mos of CP, palpitations, abdominal pain. ESR-104, CRP 85 mg/L. CT showed thickening of the thoracic & abdominal aorta. After 6wks Rx w/ AZA, HCQ, Pred, ESR/CRP still high and pt stared on SC TCZ w/ improvement. https://t.co/IWm3ZQLBUN
Dr. John Cush @RheumNow( View Tweet )
FDA has announced "Breakthrough Designation" for 3 drugs + 1 test being developed: ** Biogen: litifilimab (targets dendritic cells) for cutaneous lupus ** Novartis: Ianalumab (BAFF blockade) for Sjogrens ** J&J: Nipocaiimab (FcRn) for Sjogrens ** Encarta: pocket Lyme test https://t.co/zODOTWyqP8
Dr. John Cush @RheumNow( View Tweet )
The EMA CHMP has started a review of oral complement C5 inhibitor avacopan (Tavneos) based on serious questions about amendments to the data from the pivotal ADVOCATE study. The drug was approved in 2021 for use in GPA & MPA. https://t.co/a5ggUqk1dG

Dr. John Cush @RheumNow( View Tweet )

DMARD Responses in Localized Scleroderma JAMA Dermatology has published the results of a juvenile localized scleroderma (JLS) trial showing that mycophenolate mofetil (MMF) and methotrexate (MTX) are equally effective in treating JLS, noting low flare rates and possibly better https://t.co/BbIS5rdRYU
Dr. John Cush @RheumNow( View Tweet )

Canada's 2025 Top 10 Funded Rheumatology Projects

Arthritis Society

Arthritis Society Canada (ASC) is Canada’s largest charitable funder of cutting-edge arthritis research, investing more than $240 million in research projects since its founding, and over $7 million invested in 2024-2025. Below are the investigators and projects that were funded in 2025.

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Methotrexate intolerance in rheumatoid arthritis

A current large rheumatoid arthritis (RA) cohort study from Cairo assessed methotrexate (MTX) use and found over half were MTX intolerant and a third of patients were noncompliant with MTX.

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Full read review of the Mechanistic Effects of Methotrexate in the Treatment of Rheumatoid Arthritis. https://t.co/PrMyZ7q3wX download here: https://t.co/aRnmRm770Z https://t.co/5B0mBjzOXQ
Dr. John Cush @RheumNow( View Tweet )
B Cells at the Brink in Sjögren Disease The current issue of Arthritis & Rheumatology reviews the current understanding of the immunopathogenesis of Sjögren disease (SjD) and how this understanding has informed drug development for this systemic autoimmune disorder. https://t.co/p3dn1Ca2ag
Dr. John Cush @RheumNow( View Tweet )
Roche Canada announced that Health Canada has approved obinutuzumab (Gazyva) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. Following four initial doses in the first year, Gazyva can be administered twice yearly https://t.co/P4dCVkoPCH
Dr. John Cush @RheumNow( View Tweet )
Expertise is valued by all, YET, (many consider) change might be risky. (happened w/ Hand-washing, antibiotics, smoking dangers, etc). "Just because the establishment doesn’t like it doesn’t mean it’s not a good idea. " - Seth Godin https://t.co/3vQ4eHa4jr https://t.co/9mIJwD1f7z
Dr. John Cush @RheumNow( View Tweet )
UK NHS has cut use of physician associates over ‘substitute doctor’ fear. The reduction in roles is being blamed by union leaders for an increasing in waiting times and consultants’ workload. Plus 76% of PAs said their scope of practice had been restricted in recent months. GMC https://t.co/i0l4x9UVhZ
Dr. John Cush @RheumNow( View Tweet )

Aortitis in Giant Cell Arteritis Treated with Tocilizumab

The The Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group studied giant cell arteritis with aortitis, comparing the efficacy of intravenous vs. subcutaneously (SC) tocilizumab (TCZ) - demonstrating the superiority of SC TCZ.

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Retractions in Rheumatology

Retraction of rheumatology studies is not uncommon; a recent analysis shows retractions have risen substantially.

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