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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. 

  1. Study of urinary soluble CD163 levels in 214 SLE pts (129 w/ LN), found urinary CD163 highly correlates w/ UPCR, active vs inactive states, predicts Renal Bx histologic activity (AUC 0.962) & renal dz flares & allows prediction of complete, partial and non-responders https://buff.ly/GkKHPye
  2. 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 https://t.co/HI1KBKZiXR
  3. Commercial claims analysis of 8855 adults w/ axSpA and/or PsA, 1771 who had joint replacements. JAK inhibitor use did not significantly reduce joint replacement (OR 0.67; 0.41–1.08), BUT TNFi, Non-TNFi biologics & DMARD users had signif fewer surgeries (OR ~0.65) vs NSAID users https://t.co/vnBnFcPxGw
  4. CDC 2025–26 Updates to Influenza Vaccination. - Most are trivalent inactivated (IIV3s) or vaccines (RIV3), few live virus(LAIV3) - FDA approved FluMist (LAIV3) for self-administration (ages 2-49) - If <18yrs, Flu vax should thimerosal free 2023/24 Flu vax prevented 7900 deaths, 9 million illnesses and 120,000 hospitalizations –there were 470K Flu related hospitalizations in 2023/24  (COVID 2020 20 mill infx, 400K deaths – vaccination lowered deaths by 90%) https://t.co/hjLBGKWNDr
  5. 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
  6. SUA levels & adverse health outcomes? Australian ASPREE trial of 11,878 older participants had baseline SUA measurements. SUA levels had NO ASSOC. w/ all-cause mortality, disability-free survival, CV Dz, MACE, cancer mortality, cognitive decline, or dementia. In females, low SUA assoc w/ increased Fx risk (HR 1.23) https://buff.ly/6G7jYZf
  7. 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
  8. RA-associated interstitial lung disease or bronchiectasis is assoc w/ increased risk of total and cause-specific mortality. retrospective cohort study using the Mass General Brigham Biobank 221 RA-LD cases (151 RA-ILD, 70 RA-BR). RA-LD higher mortality (34 vs 13/1000PY; HR 1.97). Infxn mortality more common in RA-LD (7% vs 3%, P = 0.002) https://buff.ly/XoTBOEO
  9. Dr. Sparks: SARD-ILD and serious infection risk: The elephant in the room
  10. Retrospective study of 201 IPAF (Interstitial pneumonia w/ autoimmune feat.) pts w/ F/U 5.6 yrs. ANA+ 80%, RF+ 25%, CCP+ 14%, 88% Rx w/ IS or antifibrotics. 24% died, 7.5% transplant. Comorbidies were common; mean CCI 3.2; IPAF mortality worsened by  omorbidities. https://buff.ly/ymbdLHC
  11. Definitions for Interstitial Lung Disease: A Consensus from the Fleischner Society https://t.co/gEqmkdJLDh
  12. Dr. Dinesh Khanna  What you need to know about scleroderma-related lung fibrosis
  13. Hospital for Special Surgery (HSS) reports that ear acupuncture applied during hip replacement surgery reduces pain and lessens opioid use over the weeks to follow. https://t.co/lOrwb1DzW5
  14. RCT of 800 adults w/ Chronic LBP, acupuncture (AP) was compared usual care or AP +/- added maintenance found that acupuncture improved pain-related disability at 6 months and 12 months, with no statistically discernible benefit of additional maintenance sessions. https://t.co/suy09fGxxI
  15. STOP-RA: Hydroxychloroquine Fails in ACPA+ Arthralgia
  16. GLP-1 Drugs Reduce Rheumatoid Arthritis Symptoms
  17. GLP-1 drugs cost-effective for knee osteoarthritis and obesity
  18. RheumNow Live Feb 7, 8, 2026 DFW
  19. ACR2025 Chicago, IL  6 weeks away.

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The author has received compensation as an advisor or consultant on this subject
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