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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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Vamorolone: a New Steroid on the Horizon?
Vamorolone is a potentially new alternative to traditional glucocorticoids for use in inflammatory diseases.
Steroids, Prophylaxis and Pneumocystis Pneumonia
A case-control study has shown that glucocorticoids and tapering glucocorticoids are risk factors for the development of Pneumocystis jirovecii pneumonia (PJP).
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.
Diagnostic delays and Undertreatment of Psoriatic Arthritis
EurekAlert!
New research from the University of Bath in the UK reveals delayed diagnosis and undertreatment of psoriatic arthritis often results in irreversible damage to joints.
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EMA's EudraVigilance (safety) database study of 10,319 MTX reports (age: 62 yrs, 73% F). Adverse rxns (ADR): 365 kidney & 1,082 liver related. MTX renal ADRs were older, w/ comeds (NSAIDs, Tylenol, metamizole, steroids). More deaths w/ renal ADRs than liver(21% vs 6%); mostly w/ https://t.co/sZYZla0q1X
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
French REGATE registry study examined RA pts (n 1496) & Safety of tocilizumab (exposure 3991 PYs). 63 (4.2%) developed 75 cancers (35 solid, 11 Heme, 3 melanomas, 26 NMSC). CA incidence rate (excluding NMSC) was 7.5 /1000 PY. Independ Risk factors for solid CA = age (HR=1.05), https://t.co/3q8HIPa6qf
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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/7sY1sX9B3O https://t.co/EislRI5WAy
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
📢 Federal funding for lupus research and the Lupus Research Program within the Department of Defense hang in the balance as Congress debates spending priorities.
🔬 Investing in lupus research – and all medical research – is one of the wisest investments we can make. That’s why https://t.co/OgWo5z0fMB
Lupus Research LupusResearch ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
Congrates to Arthritis Research & Therapy on their 25th anniversay - 25 years of research and therapy in arthritis. Started 25 yrs ago by Drs. Peter Lipsky and Ravinder Maini https://t.co/4GFj9qktzr https://t.co/bUz0Ms0y6M
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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
Dr. John Cush RheumNow ( View Tweet)
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/EeSuBiYx5Q
Dr. John Cush RheumNow ( View Tweet)
