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Pharma/Regulatory

Primary CNS angiitis - an uncommon vasculitis affecting brain, spinal cord, or leptomeninges, typically B/L, but here are 48 pts w/ unilateral PACNS. Dx is made by imaging, wall imaging (VWI), perfusion, spectroscopy. Histology shows small-to med vessel lymphocytic vasculitis https://t.co/xtD7wBT1J2
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ILD Begins (8.29.2025)

Dr. Jack Cush reviews the news and journal reports from RheumNow.com. This week news on vaccines, safety of acetaminophen and more.

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Long-term Lab Monitoring in RA is Inefficient

Annals of Internal Medicine has published a retrospective study of long-term routine laboratory toxicity monitoring (lt-RLTM) in patients receiving disease-modifying antirheumatic drug (DMARD) therapy showing that most very abnormal laboratory finding occur early in therapy (first 6 months) or

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While the live-attenuated vaccine, Ixchiq, was pulled for safety concerns, there is another chikungunya vax still on the marked - a virus-like particle vaccine, Vimkunya. Travelers or the elderly at higher risk of chikungunya exposure should consider getting vaccinated

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Wait! FDA approved the Chikungunya Virus Vaccine 2 yrs ago, but just pulled the vaccine, Ixchiq, citing serious safety concerns (specifically CBER reports of >20 serious adverse events, including 21 hospitalizations, 3 deaths, w/ 1 fatality directly linked to vaccine-derived https://t.co/k5wBtsGVIs
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Methotrexate intolerance in rheumatoid arthritis

Methotrexate (MTX) is the most commonly used DMARD in rheumatoid arthritis (RA); however, there is significant intolerance to this drug among adult RA patients - especially at doses above 15 mg per week. 

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Celltrions tocilizumab biosimilar, tocilizumab-anoh (Avtozma, CT-P47), had similar efficacy when switching from reference tocilizumab (Actemra; Genentech) in a study of 444 RA patients x 52 wks. https://t.co/7aAyuUkZJ9 https://t.co/kJUrRkhstb
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Cardiovascular Sequelae in Adults After Kawasaki Disease A long-term cohort study of children diagnosed with Kawasaki disease (KD) shows evidence of future adult cardiovascular complications and hospitalizations. These severe cardiovascular events clustered during the young KD https://t.co/zbo64gAV1H
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AbbVie announces positive topline results from a 2nd Phase 3 UP-AA Trial evaluating Upadacitinib in Alopecia Areata (AA) - w/ 45% and 55% of severe AA pts rx w/ UPA 15 mg and 30 mg, achieving a SALT score ≤ 201 (80% or more scalp hair coverage) at week 24 https://t.co/8p1FvJx0s0
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Rapid rituximab infusions are safe & efficient. Metanalysis of 7 RCTs, 538 pts w/ autoimmune/rheumatic dz, showed infusions(RTX 1000 mg) of 90-120 min (w/ premedication) had low risk (3-15%) of mild (Grades 1, 2) infusion Rxns; only 6 Grade 3 Rxns https://t.co/uVKuhhc80F https://t.co/NIMMhgIRzH
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FDA has granted Soligenix "Orphan Drug Designation" to study dusquetide in the treatment of Behçet's dz, based on an 8 patient proof of concept Phase 2a trial. Not yet FDA approved, dusquetide is a short peptide innate defense regulator (IDR). Behcets affects 18K in USA and https://t.co/RzzVuQ6bAB
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Telitacicept, a BLyS (BAFF)/APRIL dual-target fusion drug, announced it has met the primary endpoint in its Phase III clinical trial in treating primary Sjögren's syndrome (pSS) in China. Primary endpoint was the change in ESSDAI score at Week 24. https://t.co/afOgpGLdV1 https://t.co/9EKbbrCgTL
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Sjögren's Graduates (8.22.2025)

Dr. Jack Cush reviews the news, journal reports, FDA approvals, drug safety, and more from this week.

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It's now called Sjögren Disease!

Sjögren syndrome is now Sjögren disease, according to recommendations stemming from the 2023 International Rome consensus for the nomenclature of Sjögren disease.

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The global autoimmune disease treatment market was valued at $7 billion USD in 2024 and is expected to rise to ~$11 billion by 2030 and reach $12.6 billion by 2032 https://t.co/C5IQ0hUvQE https://t.co/RjbMo5cCOl
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Safety of Combination Targeted Therapies in Psoriatic Arthritis

MedPage Today

Treating psoriatic arthritis (PsA) patients with more than one targeted therapy appears to be just fine, with no increased risk of serious infections, insurance claims data indicate.

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Rheums Speak: Future of Rheumatoid Arthritis

The third survey in this series addressed clinician views on future trends (AI), future therapies and lessons learned.

This survey captured 233 responses from rheumatologists (91), most (61%) from the USA. US respondents were from the Southeast (17.5%), Southwest (11.4%), Mid-Atlantic (

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TNF Inhibitors in Takayasu's Arteritis A large, retrospective, multicenter study demonstrated the efficacy of intravenous infliximab and subcutaneous adalimumab in patients with Takayasu arteritis. https://t.co/lJbvaYnylO https://t.co/uRBruhW2Fd
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Uncertainty with immunosuppressive for idiopathic inflammatory myopathies

A current Cochrane review suggests a continued unmet need regarding the status and utility of targeted immunosuppressant and immunomodulatory treatments for the idiopathic inflammatory myopathies (IIM). Overall there has been little progress since the previous Cochrane review (2012) that found

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FDA Approves 1st new Fibromyalgia drug in 15 yrs - Tonmya (cyclobenzaprine HCl sublingual) as treatment of fibromyalgia in adults. Based on 2 phase 3 trials and 1400+ pts. Dose 2.8 mg tabs 1-2 SL qhs (peak concentration 4.3 hours; t1/2 life = 36 hrs, longer w/ elderly, liver dz) https://t.co/8DVRet5sjU
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Advances in Still's disease Rx: - using IL-1 or IL-6 inhibitors 1st line - New FDA approval of emapalumab (IFNg) for MAS - unclear if biologics can cause lung probs in Stills https://t.co/zSqTcOSVGE https://t.co/8GhoamkV4N
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Inefficiencies of ANA Testing The Journal of Rheumatology has published an analysis of antinuclear antibody (ANA) multiplex testing showing its nonspecific utility and poor rate of return in identifying ANA-associated autoimmune rheumatic disease (ARDs). https://t.co/85B70egGBw
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Wondering what rheumatoid arthritis experts think about the future of treatment? Dr. Jack Cush moderates a special Tuesday Nite Rheumatology session, live at 7 PM ET on August 26th, where experts will dive into a nationwide survey on the evolution of biologics and DMARDs. Hear https://t.co/afYRarqjvj
Dr. John Cush @RheumNow( View Tweet )
Biologic Switching in Psoriasis A systematic review and meta-analysis found that biologic switching was effective in a significant number of psoriasis patients; but there may be a price to pay. https://t.co/QEv5jx9AIo https://t.co/06keUfXwRT
Dr. John Cush @RheumNow( View Tweet )

Teaching You How to Think… (8.15.2025)

Dr. Jack Cush reviews the news, journal reports and press clippings from the past week on RheumNow. Positive results in a Sjogren's trial, to PT or not to PT, and  aphorisms to live by.

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