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Big Fat FDA Pink Slip (9.19.2025)
Dr. Jack Cush reviews the news and journal reports from this week on RheumNow.com. Today we cover GLP-1 agonists, acupuncture, what JAKs won’t do & an FDA Pink Slip.
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Equal Safety of JAK Inhibitors and TNF Inhibitors
JAMA has published a systematic review and meta-analysis of head-to-head studies showing there was no meaningful difference in safety events observed when taking either JAK inhibitor (JAKi) vs TNF antagonist (TNFi) therapies for the treatment of immune-mediated
STOP-RA: Hydroxychloroquine Fails in ACPA+ Arthralgia
Deane et al has published the results of the STOP-RA trial, demonstrating that 12 months of hydroxychloroquine (HCQ) did not prevent the development of clinical RA at 36 months.
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Single-center retrospective study 49 pts w/ primary angiitis CNS (PACNS) stratified by vessel size. Vessel size dx by imaging & neuroradiologists. Small vessel involv(n 9) was significantly assoc w/ +Biopsies, CTX use, functional decline & more relapses. https://t.co/DF6DknoPxY https://t.co/puc6nvEAut
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Guselkumab (Tremfya) 1st IL-23 inhibitor to be FDA approved for subcutaneous induction in adults with ulcerative colitis https://t.co/KaZVzyomeY
Dr. John Cush RheumNow ( View Tweet)
Join us Sept 23 @ 7PM ET for the next Rheum to Breathe Journal Club!
We’ll dive into two pivotal ILD studies:
📄 FIBRONEER (Nerandomilast in PPF) – NEJM 2025
📄 RECITAL (Rituximab vs Cyclophosphamide in CTD-ILD) – Lancet
Panelists: Dr. Toby Maher, Dr. Shervin Assassi
Moderator: https://t.co/BebFhDJ1mM
Dr. John Cush RheumNow ( View Tweet)
STOP-RA: Hydroxychloroquine Fails in ACPA+ Arthralgia
Deane et al has published the results of the STOP-RA trial, demonstrating that 12 months of hydroxychloroquine (HCQ) did not prevent the development of clinical RA at 36 months.
https://t.co/wsnc9uZi1P https://t.co/MwZJAQs7Rt
Dr. John Cush RheumNow ( View Tweet)
Call to Update the Classification Criteria in Idiopathic Inflammatory Myopathies (IMM), Why?
- EULAR/ACR myositis criteria dont cover specific myositis subtypes
- Polymyositis is rare
- antisynthetase & necrotizing myopathy & Jo1 Dz not well represented
- Need to include MSA, https://t.co/P9CEXmEOxl
Dr. John Cush RheumNow ( View Tweet)
SMART study - Single vs. Split Dose Methotrexate in RA
Split dose weekly, oral methotrexate (MTX) was shown to be superior to single dose MTX in treating active rheumatoid arthritis (RA) patients.
https://t.co/K0C63GgHvn https://t.co/FTJ11fpKnB
Dr. John Cush RheumNow ( View Tweet)
This is a pivotal trial. 187 pt w/ incomplete lupus (ANA+ plus 1-2 criteria, but not qualifying as SLE) shows that HCQ does not prevent progression to SLE! Congrats to these researchers lead by Nancy Olsen et al. https://t.co/NnrA8ohiGX
Dr. John Cush RheumNow ( View Tweet)
August 29, 2025, FDA has terminated the Arthritis Advisory Committee, citing infrequent meetings & that the effort and expense of maintaining the committee “is no longer justified.”
The committee last met on 5/6/21 to review avacopan - that was subsequently approved. REALLY? https://t.co/w3Z6TszeWZ
Dr. John Cush RheumNow ( View Tweet)
When Myositis Hits the Lungs: What Every Rheumatologist Should Know About ILD
When idiopathic inflammatory myopathies (IIM) affect the lungs, the consequences can be serious. Interstitial lung disease (ILD) is not only common in IIM, but also one of the leading causes of death, https://t.co/qRoTr3r84x
Dr. John Cush RheumNow ( View Tweet)
🆕 ILD (Part II): advanced insights
🫁 Multidisciplinary management
💊 Treatment strategies
📊 Prognosis & monitoring
🧑⚕️ What rheums should know next
⬇️ Download & learn more: https://t.co/dmhULfqiMj
Created by
@MithuRheum | For our Rheum to Breathe: ILD Campaign https://t.co/ivvDjxkCvt
Dr. John Cush RheumNow ( View Tweet)
August 29, 2025, FDA has terminated the Arthritis Advisory Committee, citing infrequent meetings & that the effort and expense of maintaining the committee “is no longer justified.”
The committee last met on 5/6/21 to review avacopan - that was subsequently approved. REALLY? https://t.co/w3Z6TszeWZ
Dr. John Cush RheumNow ( View Tweet)
Nitazenes — a class of highly potent synthetic opioids — are rapidly emerging as a major contributor to the overdose crisis; they are over 20 times more potent than fentanyl. Nitazenes are an illegal Schedule I drug that are rapidly spreading in the illicit drug market
Dr. John Cush RheumNow ( View Tweet)
Target trial emulation looked at CV (MACE) events in 18,120 propensity score–matched adults with gout starting allopurinol who were given NSAIDs or colchicine for prophylaxis. MACE & CV death were signif. higher w/ NSAIDs vs Colchicine (HRs of 1.56 and 2.50), respectively. https://t.co/0T8slmPBng
Dr. John Cush RheumNow ( View Tweet)
What are the Pros and Cons of autologous CAR T cell therapy?
Summary slide from Georg Schett who also mentioned the exciting in vivo CAR approach using nanoparticules in myeloma, something to stay tuned for
@RheumNow #APLAR25 https://t.co/kWjrx6N9Dv
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Aurelie Najm AurelieRheumo ( View Tweet)
Different B cells depletion strategies in SARDs highlighted by Georg Schett
From low and short lived depletion achieved w/ drugs to sustained deep tissular depletion with CAR T cells leading to potential immune reset
@RheumNow #APLAR25 https://t.co/t35lrzEomF
Aurelie Najm AurelieRheumo ( View Tweet)
Paradigm shift in CTD PAH
-Early triple therapy in patients with intermediate and high risk
-Sotatercept,
a blocker of activin-Smad2/3 signaling
have increased survival importantly
Data presented by Dr Khanna
@RheumNow #APLAR25 https://t.co/Z4yA6DwtOb
Links:
Aurelie Najm AurelieRheumo ( View Tweet)
TNR: Future Treatment of ILD
This Tuesday Night Rheumatology webinar reviewed ACR and EULAR guidelines on interstitial lung disease, with a focus on ‘where are we now and where are we going?’ in regards to treatment strategies and emerging therapies in ILD care. https://t.co/F1fJhWgR5O
Dr. John Cush RheumNow ( View Tweet)
