NME: New Molecular Entities (8.28.2026) Save

Dr. Jack Cush reviews the news and journal articles from this past week on RheumNow.com

1. Aortic inflammation (Aortopathies) occurs in autoimmune rheumatic diseases (ARD) including Takayasus, #GCA, SLE, RA, AS, SSc, relapsing polychondritis, Cogan’s syndr, Behçet’s, & IgG4-related disease). Dx imaging options: CTA, MRI, & PET/CT. Underlying path may be granulomatous, https://t.co/lKBhEnTcKB
2. Spyre Therapeutics topline results of its anti-TL1A Ab (SPY072) in RA (n 133) sub-study: Phase 2 SKYWAY 12wk trial showed 2 doses SPY072 were signif better vs PBO for ACR20 (63% & 58% vs 43%), ACR50 (31% &38% vs 19%), DAS28-CRP reductions (-1.5 & -1.9 vs -1.3). TL1A inhib are the hot new Rx. https://t.co/S6gapB21uq
3. Ivarmacitinib (AKA SHR-0302) is a JAK1 inhib approved in China. Phase II/III RCT (NCT04481139) in active #AS Rx w/ ivarmacitinib 4 mg (n 187) or placebo (n 186) showing IVRMA @wk 12 IVRMA had signif better ASAS20 response(49% vs 29%) & ASAS40 (32% vs 18%). Also superior:  total back pain VAS, night pain VAS, ASDAS; w/ cont efficacy thru wk 24 https://t.co/ilVtrQgHxR
4. Phase 1/2 COMPARE trial of CD19 CAR-T Rx in 6 ACPA+ RA pts w/ severe refractory Dz; after lymphodepletion, given mivocabtagene autoleucel (miv-cel), followed < 52wks. All had CRS, No ICANSs or serious AEs. All had CD19 cell depletion & Decr in AutoAbs. Efficacy: 3/6 had ACR70 & https://t.co/qfSdq2g0rk
5. CAR-T Reality Check! The hype is outrunning the evidence, which now lives in a handy dashboard created and presented by Dr. Mike Putman @EBRheum. There are almost as many studies as there are CAR-T treated patients. Few numbers, limited F/U - Yet everyone is gaga about CAR-T. https://t.co/aCtA8il2fD
6. VA study of 4108 RA-ILD (2006-21). PRED use was 65-77%, A& 1st line Rx (MMF, AZA, RTX, CTX) incr after ILD, use was low (1.2-12%). MTX decr (47 to 30%), but LEF, TNFi, ABA incr. Predictors of ILD Rx: FVC, CCP+, ILD Dx after 2012. https://t.co/GT3Vwo11w1
7. 402 RA pts w. symptomatic Extra-articular manifestations (eg, neuropathy, KCS) had significant impairment in quality of life and work productivity, independent of disease activity. They had lower HAQ (0.92 vs 0.68) & more Absenteeism https://t.co/1FH9gyxoxK
8. JAK inhibitor Drug Market size (worldwide) was valued at $ 5.51 Billion in 2024 & is estimated to reach $ 19.81 Billion by 2033, exhibiting a Compound Annual Growth Rate of 13.66% from 2026-2033. https://t.co/1Krd1TeKv1
9. e-cigarette use assoc w/ a 1.5-fold incr risk of RA & SLE. All of Us Research prg matched 15,909 e-cig users vs nonusers. 66 new RA or SLE among current e-cig (IR 1.43/1,000PYs) vs nonusers (0.93/1,000PYs; IRR 1.54); applies to past or current smokers https://t.co/xYRezwQFYC
10. 39 studies compared Juvenile systemic sclerosis (jSSc) & adult SSc. 935 jSSc vs 15,451 aSSc pts; jSSc had more diffuse cutaneous dz (70% vs 41%), more overlap myositis (33% vs. 5%), arthritis (33% vs 18%), digital ulcers (51% vs 20%), less renal crisis (0% vs 6%) & lower mortality jSSc (7.7% vs. 20.4%) https://t.co/vflarmwSyv
11. Effect of apremilast on entheseal bone damage in at risk psoriasis patients - 20 long-standing PsO pts (freq nai,scalp dz) (b/tsDMARD-naive) Rx w/ OL apremilast 30 bid x 6 mos. Enthesitis (MRI or HR-pQCT) stable, PsAMRIS stable; no new erosions, but PASI (11-->5) & TJC signif improved (3.2-->0.8)  https://t.co/xfQGcW0yz7
12. Does exercise affect inflammatory biomarkers? Metanalysis of 61 studies shows mostly low certainty evidence of inflammation-modulating effects of exercise. In most chronic diseases, exercise showed anti-inflammatory trends w/ reductions in CRP, IL-6, TNF-α https://t.co/EP74b3mVAT
13. Japanese study of 101 864 children shows fertility treatments (ovulation induction, intrauterine insemination, invitro fertilization) increases the risk of Kawasaki Dz. Incidence rates per 100K PYs - 274 for spont conception vs 391 for assisted conception (adj HR 1.42; 1.18-1.70) https://buff.ly/pRpNiMv
14. Registry Data Shows Liver Risk With Avacopan A new study may add fuel to the fire already burning around avacopan (Tavneos), approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), which the FDA wants drugmaker Amgen to pull from https://t.co/nHF6RVpq2Z
15. Retrospective Medicare comparison 450 paired #PMR cohorts Rx w/ IL-6 inhib or csDMARDs. At 1 yr, IL-6i pts (vs csDMARD) had signif more GC D/C (adj HR 1.28) or minimal GC use (<3mg/d) (aHR 1.28). Hosp. infxn 2X higher in IL-6i (12.2 vs 5.7 per 100 PY) in year 1, but not year 2 https://t.co/G4eIusHDPa
16. Secukinumab in Polymyalgia Rheumatica
17. Brepocitinib Skin Outcomes in Patients With Dermatomyositis
18. Insights into Sjögren’s Disease - A Rheum Survey