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An Epidural Letdown (4.4.2025)
Dr. Jack Cush reviews the news and journal reports from this past week on RheumNow.com.
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EMA has approved upadacitinib (Rinvoq) for use in the EU to treat adult patients with giant cell arteritis (GCA) - approval is based on data from the Phase 3 SELECT-GCA trial demonstrating sustained remission and key secondary endpoints https://t.co/Y2tyZPC9Et https://t.co/SHPz2Q94Vs
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Korean insurance claims study (2008–2021) 183,212 psoriasis & PsA pts, found Biologic Rx assoc w/ lower risk of new-onset & recurrent MACEs vs phototherapy (adj HR, 0.45 & 0.34). Nonbiologic systemic Rx lowered MACE risk (v photoRx) only in pts w/ prior Hx MACE (0.79) https://t.co/08wNm1AbpC
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Does DMARD Rx affect neurocognitive function in older pts? bDMARDs targeting TNF-α & IL-6 may mitigate neuroinflammation & preserve cognitive function. But, cognitive impact of csDMARDs (MTX) is complex, w/ conflicting reports on its role in vascular dementia. https://t.co/6uMmOOdRoF
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EMA has approved upadacitinib (Rinvoq) for use in the EU to treat adult patients with giant cell arteritis (GCA) - approval is based on data from the Phase 3 SELECT-GCA trial demonstrating sustained remission and key secondary endpoints https://t.co/ycPNuB8C8y https://t.co/MCJNltn8Lj
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Topline results from Phase 3b APEX study, comparing guselkumab to placebo in biologic naive #PsA pts - showed significant improvement by ACR20 and significantly less Xray progression of structural damage (vs PB) at Week 24 https://t.co/YkUspqd92h https://t.co/cmAUWaScri
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FDA announced approval of Inebilizumab (Uplizna; Amgen), 1st approved Rx for IgG4-related disease (targets CD19+ B cells). IG4-related Dz is estimated to affect 20,000 in the USA. List price is $140,248.50 per dose, After two initial loading doses it is given q 6 mos. https://t.co/aD9yBVJukQ
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Vamorolone: a New Steroid on the Horizon?
Vamorolone is a potentially new alternative to traditional glucocorticoids for use in inflammatory diseases. It is a dissociated steroidal compound with reduced side effects, and in an animal model of inflammation has shown effective https://t.co/zHDyJbU23q
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Upadacitinib for Giant-Cell Arteritis - A Phase 3 Trial
The NEJM has published a randomized controlled trial in giant-cell arteritis (GCA) patients, demonstrating significant efficacy and safety of upadacitinib (UPA), given as 15 mg daily, as compared to placebo. https://t.co/Njmg2PKAbq
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1st Line Biologics vs. csDMARDs in Adult Still's Disease
A German multicentre, retrospective study assessed the first-line efficacy of biologics and conventional synthetic DMARD therapy in patients with adult-onset Still's disease (AOSD) and found biologic agents were https://t.co/NaxACbmyxl
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Topline results from Phase 3b APEX study, comparing guselkumab to placebo in biologic naive #PsA pts - showed significant improvement by ACR20 and significantly less Xray progression of structural damage (vs PB) at Week 24 https://t.co/0Ra8eUeBOi https://t.co/0dwOSxjVxs
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FDA announced approval of Inebilizumab (Uplizna; Amgen), 1st approved Rx for IgG4-related disease (targets CD19+ B cells). IG4-related Dz is estimated to affect 20,000 in the USA. List price is $140,248.50 per dose, After two initial loading doses it is given q 6 mos. https://t.co/zHD2Yv3PjI
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Systematic review 21 studies showed potential of RTX with IVIg in autoimmune Dz - 10 studies on pemphigus (85 pts) - all Positive outcomes except 1 paraneoplastic pemphigus. Infections (eg, P. jirovecii pneumonia) seen in 3. 11 studies (24 pts) Rx'd neuropathies, CND lupus& https://t.co/o0RRUBIqmS
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Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act (by Dr. Sara Yim, FDA)
- BPCIA enacted March 23, 2010
- created pathway for biosimilar approvals
- Now ~70 FDA approved biosimilars; 18 in 2024
https://t.co/dhST5vAJyT https://t.co/BWefr7k9hh
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An estimated 118,000 people throughout the world have EGPA. Steroids & immunosuppressants have been the mainstay; but for managing EGPA. Mepolizumab (2015) & Benralizumab (2024) are FDA approved for EGPA. The latter (Fasenra) approval based on the MANDARA trial https://t.co/84W4sOig9d
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To promote broader avail. of biosimilars in EU, EMA has proposed a new path for new biosimilars, omitting comparative clinical trial data, as long as biosimilar shows structural & functional comparability, w/ pharmacokinetic & interaction data (relative to reference product) https://t.co/24aTCuDwdO
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EMA approved a record 28 biosimilars in 2024 for cancer, osteoporosis, macular degeneration, and immune-related diseases like plaque psoriasis, ulcerative colitis, and Crohn’s disease https://t.co/NNzKRalLvF https://t.co/nfX082a7ON
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Vamorolone, a promising alternative to traditional glucocorticoids for inflammatory diseases.
◦ #Vamorolone is a dissociated steroid compound with reduced side effects.
◦ Unlike conventional #glucocorticoids, vamorolone lacks the hydroxyl or ketone groups and is resistant to https://t.co/yvDWqcbXbn
Alberto Giraldo alb_giraldo ( View Tweet)
Phase 3 RCT shows that SC Abatacept was not effective in treating Active Idiopathic Inflammatory Myopathy: 148 (double-blind) & 133 (OL) pts Rx for 24wks with similar improvement 56% ABA vs 42.5% PBO (P = 0.083); NS at 52 wks & w/ dermatomyositis. https://t.co/InlHJSmiKn https://t.co/mtFQWp3vlb
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Fresenius Receives FDA Approval for their Denosumab Biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) based on reference products: Prolia (denosumab) and Xgeva (denosumab) respectively. US launch mid-2025 https://t.co/0i5ZMJSxnp https://t.co/zeQ7QhmA0n
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