EMR Messaging Woes (4.11.2025)
Dr. Jack Cush reviews the news, journal reports and regulatory approvals from this past week on RheumNow.com
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FDA reports higher rate of allergic/hypersensitivity type reactions w/ certainlots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) ; these have voluntarily withdrawn by the manufacturers https://t.co/N73Cc8rfAS https://t.co/OTROyomvv8
Dr. John Cush @RheumNow( View Tweet )
Pregnancy-Related Deaths in the US
A CDC cross-sectional national study showed an increase in pregnancy-related deaths in the US from 2018 to 2022, with highest rates among American Indian, Alaska Native women, and non-Hispanic Black women.
https://t.co/H1s649GyiL https://t.co/MXnrQrAcrT
Dr. John Cush @RheumNow( View Tweet )
Summary of the updated BSR Axial Spondyloarthritis for biological and targeted synthetic DMARD guidelines 2025 @RheumatologyUK #axialspondyloarthritis
Full paper available at:
https://t.co/LytDiHjawi https://t.co/iaHzD1BQRe
Links:
Antoni Chan MD (Prof) @synovialjoints( View Tweet )
In our latest episode, @deodhara takes us behind the scenes of his research on IV secukinumab in #AxSpA. Discover key findings from the INVIGORATE-1 study, how it’s shaping treatment options, & what’s next in AxSpA research. LISTEN NOW → https://t.co/2IBixQSdpO @ACR_Journals https://t.co/HzcJw0pzWI
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American College of Rheumatology @ACRheum( View Tweet )
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/1RC8bMSZJ3
Dr. John Cush @RheumNow( View Tweet )
MMWR: While PRE-overdose opioid prescribing is a risk marker for fatal overdose from opioids alone, stimulants alone, or both; PRE-overdose stimulant prescribing might not be a risk marker for fatal overdose attributable to stimulants. https://t.co/ReVbpligeT https://t.co/PnjeqaCySX
Dr. John Cush @RheumNow( View Tweet )
Inebilizumab, an anti-CD19+ (B cell)mAb was tested in myasthenia gravis in phase 3, 238 pt trial and shows to signif. improv function and reduce disease severity in acetylcholine recpt Ab+ or muscle-specific kinase Ab+ myasthenia gravis pts. https://t.co/vBBjf8AUug https://t.co/cUbK4PJEvf
Dr. John Cush @RheumNow( View Tweet )
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/tQ9PSOTtyx
Dr. John Cush @RheumNow( View Tweet )
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
Dr. John Cush @RheumNow( View Tweet )
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
Dr. John Cush @RheumNow( View Tweet )
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 )
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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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 )
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 antiinflammatory properties and reduced systemic
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). The authors provide guidance on the optimal timing for prophylaxis use and withdrawal.
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