Pharma/Regulatory

FDA has approved nerandomilast (Jascayd) for the treatment of progressive pulmonary fibrosis (PPF) in adults, based on the results of the phase 3 FIBRONEER trial. Nerandomilast is PDE4 inhibitor,, in Oct 2026 it was approved for use in diopathic pulmonary fibrosis (IPF) https://t.co/WVrGj7q7hB
Dr. John Cush @RheumNow( View Tweet )
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Disease Activity Criteria for Adult-Onset Still's Disease: EULAR Points to Consider

Jack Cush, MD

EULAR has published a "points to consider" (PtCs) guidance on the development of criteria for the assessment of the disease activity in adult-onset Still’s disease (AOSD).

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EULAR.Docs.APP

Role of the Nurse in the Care and Management of Rheumatic Diseases - EULAR Review

Jack Cush, MD

In 2023, a EULAR subcommittee set out to assess the roles of nurses and Advanced Practice Nurses (APN) in the care of arthritis as outlined in published EULAR guidelines. The scope of APN practices was first proposed in 2012 and revised in 2018. EULAR updated its recommendations for the role

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In US, Tofacitinib loses patent exclusivity & goes generic in 2026. Worldwide Tofa sales in 2024 were $3.08 billion (55% use in RA; N. America 1st w/ ~38% of market). Tofa sales projected to rise to $5.7 bill in 2029 https://t.co/nKPaQdglYw https://t.co/DdMymmk8go

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Dr. John Cush @RheumNow( View Tweet )
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Optimizing Hydroxychloroquine Blood Levels in Lupus

Jack Cush, MD

A large observational cohort study suggests that monitoring hydroxychloroquine (HCQ) blood levels is effective in systemic lupus erythematosus (SLE) patients with a target therapeutic range (for HCQ level monitoring) of 750-1150 ng/ml.

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Survey of physician assistants finds 56% use AI daily (19% AI extensively). 87% PAs say they need to learn more about AI, 83% desire formal, employer-led AI training. 89% believe AI will dramatically changes PA practice, but only 32% have clear workplace guidelines on AI usage https://t.co/yGqZRC3mNt
Dr. John Cush @RheumNow( View Tweet )
JAMA reports that by end of 2025, half (52-56%) of USA nonfederal acute care hospitals will use generative AI and predictive AI. Teaching hospitals and EPIC EHR are early adopters, while For-profit and government hospitals were less likely to currently adopt AI. https://t.co/iJib0YjnW3
Dr. John Cush @RheumNow( View Tweet )
Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in EU/UK & Gazyva in US) in combination with mycophenolate mofetil for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. https://t.co/usUidNVMNY
Dr. John Cush @RheumNow( View Tweet )
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Reefer Madness (12.12.2025)

Jack Cush, MD

Dr. Jack Cush reviews the news, journal and regulatory reports from this past week on RheumNow.com.  B cell drugs in SLE and ITP, biomarkers in GCA & PSS and great videos by APPs.

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2025 Adult Rheumatology Fellowship Match is Strong (Again)

ACR

The American College of Rheumatology (ACR) announced today that 2025 Medicine and Pediatric Specialties Match results show rheumatology fellowship positions continuing to fill at high rates. The Match uses a computerized process to pair applicant and program preferences, determining where

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FDA has issued its final guidance on: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers https://t.co/69sbgoWnSW https://t.co/kpTgdPOkka

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Dr. John Cush @RheumNow( View Tweet )
FDA has issued its final guidance on: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers https://t.co/bjiV4S0Fur https://t.co/dDyJqhV5VF

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Dr. John Cush @RheumNow( View Tweet )
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Medical Cannabis for Pain Management

Jack Cush, MD

Recent research and publications have underscored the use, efficacy, safety and limitations to the use of cannabis for arthritis and pain patients.

Chronic pain affects more than one in five American adults, yet practitioners are limited in treatment alternatives. Even if we exclude the

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British Society of Rheumatology Guideline for Monitoring DMARDs The British Society of Rheumatology has published an update to their previous 2017 BSR/BHPR guideline regarding the use and monitoring of DMARDs (disease-modifying anti-rheumatic drugs) used to treat systemic https://t.co/7KNf6cIjfo
Dr. John Cush @RheumNow( View Tweet )
purpura

B Cell Targeting in Idiopathic Thrombocytopenic Purpura

EurekAlert!

The New England Journal of Medicine  has published a phase III clinical trial showing that a B cell targeting monoclonal antibody, ianalumab, was effective in more than half of the patients with primary immune

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Low Dose Naltrexone for Fibromyalgia Pain - Use it or Lose it? Medscape recently reviewed off-label use of low dose naltrexone (LDN) in fibromyalgia (FM) and found it is deemed effective by some clinicians and patients, but 1) there is no FDA indication for LDN use in FM and 2) https://t.co/RgRRHU9ZRo
Dr. John Cush @RheumNow( View Tweet )
Legislative Issues Affecting APPs Major interstate “compacts” allow for cross state licensing for physicians. However, compacts for Advanced Practice Registered Nurse (APRN) are fewer and currently on hold - thereby limiting healthcare manpower and patient care. https://t.co/cgzgGXIWka
Dr. John Cush @RheumNow( View Tweet )
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British Society of Rheumatology Guideline for Monitoring DMARDs

Jack Cush, MD

The British Society of Rheumatology has published an update to their previous 2017 BSR/BHPR guideline regarding the use and monitoring of DMARDs (disease-modifying anti-rheumatic drugs) used to treat systemic autoimmune rheumatic diseases (SARDs). 

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TriNetX retrospective cohort study of 1402 propensity matched Systemic Sclerosis pts on vs off SGLT2 inhib (2013-2025) & found SGLT2i significantly lowered all-cause mortality (HR 0.54), stroke (HR 0.64), & hospitalizations (HR 0.76), moreso in SSc without Hx of CHF (HR 0.62) https://t.co/CVkRJegei9
Dr. John Cush @RheumNow( View Tweet )
Changing Loan Limits for Advance Practice Providers The "One Big Beautiful Bill" (OBBB), or H.R. 1, was signed into law in July, calls for significant changes in the funding of healthcare education. This bill that lowers cap limits on education loans applies to graduate (APRN, https://t.co/4fwhAo2WG5
Dr. John Cush @RheumNow( View Tweet )
Legislative Issues Affecting APPs Major interstate “compacts” allow for cross state licensing for physicians. However, compacts for Advanced Practice Registered Nurse (APRN) are fewer and currently on hold - thereby limiting healthcare manpower and patient care. https://t.co/sBYtX03IY7
Dr. John Cush @RheumNow( View Tweet )
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Low Dose Naltrexone for Fibromyalgia Pain - Use it or Lose it?

Jack Cush, MD

Medscape recently reviewed off-label use of low dose naltrexone (LDN) in fibromyalgia (FM) and found it is deemed effective by some clinicians and patients, but 1) there is no FDA indication for LDN use in FM and 2) the data supporting its use is limited.

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WHO recommendations on GLP-1 agonists: 1) conditional recommendation - GLP-1 drugs can be used for for long-term obesity treatment by adults, except pregnant women; 2) GLP-1a use should be paired with a healthy diet and physical activity. Access to these drugs is a problem. https://t.co/jMa7rbJPby
Dr. John Cush @RheumNow( View Tweet )
TriNetX retrospective cohort study of 1402 propensity matched Systemic Sclerosis pts on vs off SGLT2 inhib (2013-2025) & found SGLT2i significantly lowered all-cause mortality (HR 0.54), stroke (HR 0.64), & hospitalizations (HR 0.76), moreso in SSc without Hx of CHF (HR 0.62) https://t.co/t6GVrN6zoQ
Dr. John Cush @RheumNow( View Tweet )
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Consensus Definitions on Difficult to Treat Psoriatic Arthritis

Jack Cush, MD

A substantial number of patients with psoriatic arthritis (PsA), have difficult, persistent and hard-to-treat disease. A GRAPPA task force has developed a consensus terminology for two distinct states: complex-to-manage PsA and treatment-refractory PsA.

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Recent Blogs

Choice Overload (and the Way Out)

Jack Cush, MD
paint,choice,overload,color
I recently overheard a very good practicing rheumatologist complain, “why do I need yet another drug for psoriatic arthritis? I have more treatment choices than I have actual PsA patients who need a new or better drug”. Read Post

Best of 2022: Methotrexate in PsA

Philip Mease, MD
Methotrexate
Until the publication of the SEAM trial, evidence in the medical literature for the efficacy of the most commonly used drug for psoriatic arthritis worldwide, methotrexate, has been lukewarm at best. Yet we all employ it commonly, either as monotherapy or in combination with biologic or targeted synthetic DMARD treatment. It is inexpensive and widely available, and only modestly toxic. Read Post
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