Pharma/Regulatory

ARD's Impact Factor The 2024 Impact Factor for ARD is 20.6 – an increase from 20.3 in 2023. This retains the journal’s position as second of 58 titles in the rheumatology category and confirms its status as the top-ranking journal for the publication of original research in both https://t.co/dtMTejkhcc
Dr. John Cush @RheumNow( View Tweet )
TONIX pharm presented two phase 3 RCTs at #EULAR2025 demonstrating efficacy of sublingual cylcobenzaprine at bedtime in w/ significant reductions in Fibromyalgia pain scores. TNX-102 SL could be the 1st new FM drug to be FDA approved in >15 yrs. PDUFA (decision) date is 8.15.25. https://t.co/XNd8uYLQsJ
Dr. John Cush @RheumNow( View Tweet )
Upcoming Lupus Nephritis Pipeline 1. Gazyva (obinutuzumab) – due for FDA/EMA decision 2. Saphnelo IV (anifrolumab) – now in Phase III (new indication for LN 3. Ianalumab SC (Dual-action B-cell inhibitor) – now in Phase III https://t.co/mTInV8JXzq https://t.co/jEv2uvhkqK

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Dr. John Cush @RheumNow( View Tweet )
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ICYMI: Axial Involvement in Psoriatic Arthritis

Jack Cush, MD

Analysis of a Greek Psoriatic Arthritis (PsA) cohort shows that nearly one quarter of patients have axial involvement, and among them, ∼30% have isolated spinal axPsA and nr-axSpA, respectively.

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JAK Inhibitors: The Latest from the JAK-pot Study Dr. David Liew reports on abstract POS0150 - Evolution of Janus Kinase Inhibitors (JAKi) Prescriptions Since 2015 In An International Collaboration of Rheumatoid Arthritis Registers (The 'JAK-pot' Study): Effect of Regulatory https://t.co/KiOZuphQTx
Dr. John Cush @RheumNow( View Tweet )
Full read overview of MDA-5 Dermatomyositis (DM) - pathogenesis, findings, & Rx. MDA-5 DM is a rare, aggressive amyopathic form with distinctive skin findings & rapidly progressive interstitial lung dz. Rx includes Hi dose steroids, calcineurin inhib & IV CTX (maybe JAKi, MMF)

Dr. John Cush @RheumNow( View Tweet )

Trends and Innovations from Barcelona (6.20.2025) Dr. Jack Cush reviews highlights, trends and novel studies from EULAR 2025 in Barcelona from last week. https://t.co/iEiQI8GACt https://t.co/X27CuZb5wH

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Dr. John Cush @RheumNow( View Tweet )
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PCR: Prevalence, Cost, & Risk (6.27.2025)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from last week on RheumNow.com

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TONIX pharm presented two phase 3 RCTs at #EULAR2025 demonstrating efficacy of sublingual cylcobenzaprine at bedtime in w/ significant reductions in Fibromyalgia pain scores. TNX-102 SL could be the 1st new FM drug to be FDA approved in >15 yrs. PDUFA (decision) date is 8.15.25. https://t.co/B5tMq147L4
Dr. John Cush @RheumNow( View Tweet )
Upcoming Lupus Nephritis Pipeline 1. Gazyva (obinutuzumab) – due for FDA/EMA decision 2. Saphnelo IV (anifrolumab) – now in Phase III (new indication for LN 3. Ianalumab SC (Dual-action B-cell inhibitor) – now in Phase III https://t.co/mTInV8JXzq https://t.co/3qg1FWzZRI

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Dr. John Cush @RheumNow( View Tweet )
Increasing costs of biologics. X-sectional study of 76 781 psoriasis pts on biologics (TNFi, IL12/23, IL-17i, IL-23i) saw annual treatment cost increase from $21 236 in 2007 to $47 125 in 2021. AVG cost could have been 44% lower if lowest-cost Rx in same class was used https://t.co/IOaK75zsgg
Dr. John Cush @RheumNow( View Tweet )
By March 2025, the FDA has approved 71 biosimilars (15 interchangeable). The US & EU biosimilars markets spent $22.58 billion in 2024 & is projected to increase by 25% to $171.79 billion by 2033 https://t.co/fsqGTzWuhC https://t.co/ZLYSIwRqI4

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Dr. John Cush @RheumNow( View Tweet )
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Remission in Axial Spondyloarthritis Unrelated to Gut Inflammation

MedPage Today

Most patients with early, active axial spondyloarthritis (axSpA) who quickly received a tumor necrosis factor (TNF) inhibitor experienced remission, and it didn't matter whether or not they had intestinal inflammation at baseline, a small single-arm study found.

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EMA has published a concept paper about the need for guidance to inform the development of systemic sclerosis (SSc) treatments. They have identified study designs & endpoints; exploratory and confirmatory trials, and assessments of safety and efficacy. See draft here: https://t.co/WADBrw2uXe

Dr. John Cush @RheumNow( View Tweet )
A new mechanism of action in SARD-ILD Nerandomilast, an inhibitor of phosphodiesterase 4B, orally administered, is a new mechanism of action to treat lung fibrotic diseases. FIBRONEER-ILD, the Phase 3 RCT of Nerandomilast in patients with progressive pulmonary fibrosis, was https://t.co/goikCwJa2x
Dr. John Cush @RheumNow( View Tweet )
FDA has approved a SC autoinjector of Benlysta (BEL) for use in pediatric lupus nephritis & pts > 5rs of age for SLE and active LN. BEL SC dosing for Pediatric SLE: 200 mg qwk (>40 kg) or 200 mg EOW (q2wk) if 15-40 kg. https://t.co/xrMJUgdSWv https://t.co/UJ2LZ3dU5p

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Dr. John Cush @RheumNow( View Tweet )
Full read overview of MDA-5 Dermatomyositis (DM) - pathogenesis, findings, & Rx. MDA-5 DM is a rare, aggressive amyopathic form with distinctive skin findings & rapidly progressive interstitial lung dz. Rx includes Hi dose steroids, calcineurin inhib & IV CTX (maybe JAKi, MMF)

Dr. John Cush @RheumNow( View Tweet )

Deucravacitinib's Place in the PsA Treatment Algorithm? Dr. Eric Ruderman offers his perspective on where deucravacitinib will fit in the treatment algorithm and trials presented at the EULAR 2025 meeting in Barcelona, Spain. https://t.co/6Ozrvr5IMt https://t.co/w7FJs4wir9

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Dr. John Cush @RheumNow( View Tweet )
Which CAR T Cell is Mighty? Dr. Yuz Yusof talks with Dr. Chris Wincup about CAR T data being presented at the EULAR 2025 meeting in Barcelona, Spain. https://t.co/MkRoqlvdub https://t.co/R0dtllmo7Q

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Dr. John Cush @RheumNow( View Tweet )
Psoriatic Arthritis: Hit hard and Early Two studies found no significant benefit of early biologics over standard methotrexate treatment, but they did not focus on poor prognosis cases. The SPEED trial, funded by the NIHR, aimed to compare disease activity in 192 PsA patients https://t.co/Vte0RSyszN
Dr. John Cush @RheumNow( View Tweet )
EULAR Points to consider for the definition of D2M and TR #Psoriatic_Arthritis Presented by Dr Helena Marzo-Ortega at #EULAR2025 @RheumNow https://t.co/3LsJvSiXJV

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Nelly ZIADE 🍀 @Nellziade( View Tweet )
#EULAR2025 Abstr#OP0041 FcRn-inhibition is showing consistency in #Sjogren. Last year it was Nipocalimab. This proof-of-concept study showed efgartigimod met its primary endpoint, the CRESS response. No difference in ESSPRI. Phase 3 UNITY is underway @RheumNow https://t.co/jw1i4FqkIh

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Md Yuzaiful Md Yusof @Yuz6Yusof( View Tweet )
#WIN in systemic sclerosis (SSc): -Ongoing trials now targeting multiple pathways. -CONQUEST platform may reshape research in Ssc and other autoimmune diseases. -Revised CRISS could replace single organ endpoints for approval. #EULAR2025 @RheumNow https://t.co/kxSeFb5lAU

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Adela Castro @AdelaCastro222( View Tweet )
APEX study showed significant inhibition of structural damage progression with both dosing regimens (Q4W and Q8W) of GUS (IL-23i) in biologic-naïve pts with active PsA. Abstract #LB0010 #EULAR2025 @RheumNow https://t.co/QxYAPGB67v

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Adela Castro @AdelaCastro222( View Tweet )
Management of AAV: 1.High dose GC f/b reduced dose taper ‼️caution in pts w/severe renal dz and RTX induction. 2. RTX effective for induction and maintenance, best for relapses. 3.PLEX: in RPGN pts if accesible ⚠️ risk for infection. 4.Avacopan: for faster GC weaning. No https://t.co/kfZ4gM38KG

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Adela Castro @AdelaCastro222( View Tweet )

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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