A New RA Approval (8.1.2025)

Dr. Jack Cush reviews the news, journal reports and a new treatment for RA from the FDA.

  1. Pregnant Women on TNFi more likely to use throughout gestation, w/ less steroids. 3711 preg on TNFi in 49,925 F (w/ RA, AS, PsA, PsO, IBD) -- 64% had 3 trimester TNFi use. 89% exposed preconception & 68% cont postpartum. TNFi use incr from 55% to 73% (20111-21) https://t.co/DVvbwx6MoW
  2. CARRA registry study of 2,956 JIA pts (activity: 71% inactive/minimal, 25% persistent moderate/high, 2% “improving”, 2% “flaring”). In 12 mos, Only 10% had DMARD escalation & only 15% escalation despite 2 consecutive visits w/ persistent moderate/high disease activity. This is NOT T2T https://t.co/Gviwgfcdrk
  3. Mild cognitive impairment (MCI), (a reversible precursor to dementia) is increased in elderly RA (n=378) and is signif. assoc w/ course of disease (OR 1.07), DAS28 (OR 1.31), high CRP (OR 1.01) & osteoporosis (OR 1.88) as independent risk factors. https://t.co/45DY03sD23
  4. MTX or TNFi use in elderly #RA pts w/in a year of Dx of melanoma was not associated with increased mortality. This included melanoma in situ (48%), localized (47%) and regional (5%) melanoma. Steroid use however was assoc w/ reduced survival. https://t.co/QOXfEf51S1
  5. RA & GOUT? S. Korean study of 34,356 new RA pts vs 103,068 controls. RA had 2.7 X higher risk of gout vs non-RA. Seropos & Seroneg equal incr risk (aHR 2.8 & 2.6), slightly higher in SPRA(aHR 1.07). RA on b/tsDMARDs had lower risk (aHR, 1.93) vs Untreated (aHR, 2.78). https://t.co/P0oqq5bVnq
  6. Plant extracts, C. longa & B. serrata extracts (CBTIL) studied in hand OA in 3 mos, DBRPCT of 162 HOA pts given CBTIL (n83) or PBO (n 79). Also signif were decreased Pt global, acceptable symptom status (PASS), SF-36 pain, SF36 health change (no AE diff) https://t.co/vqhqnEZIsz
  7. "FLAME" - machine learning model developed to predict SLE flares. Data from 28,433 SLE pts (2011-2022) looked at clinical & social determinants of health (SDoH) to predict 3 mo flare risk. AUROC = 0.67; SHAP analysis identified HA, OBS, & pyuria as predictors. Is this the future? https://t.co/6Eqqc9w2oV
  8. Systemic immune-inflammation index (SII), as a potential biomarker -- computed as platelet count × neutrophil count/lymphocyte count. SII has been shown to be useful in RA, PsA, SpA, SLE and vasculitis, reflecting disease activity, drug responses & supplements ESR & CRP levels https://t.co/LuFaYbWiWN
  9. FDA is evaluating the safety of Vyvgart Hytrulo, ((efgartigimod) used to treat AChR Ab positive generalized myasthenia gravis (gMG). But in clinical trials there are reports of "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)” https://t.co/6GBwIJ4ig4
  10. FDA Approves Vagal Nerve Stimulator for RA 
  11. Rituximab is not Superior in EGPA 
  12. HCQ Preserves Renal Function in Lupus Nephritis   

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The author has no conflicts of interest to disclose related to this subject
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