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Pharma/Regulatory

FDA Approves Vagal Nerve Stimulator for RA SetPoint Medical announced the FDA approved the SetPoint System, a neuroimmune modulation treatment for moderate-to-severe rheumatoid arthritis (RA), for patients not well-managed or cannot tolerate—existing RA therapies like https://t.co/MtVny1iBQ4
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2025 BSR Recommendations for ANCA-associated Vasculitis The BSR and BHPR have published a guideline for the management of adults with AAV; specifically three conditions: GPA, MPA, and EGPA. https://t.co/nYpbBK7Ahr https://t.co/J4KcAzA5Xd
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Retrospective study of 63 pts w/ Cryoglobulinemia (essential mixed [EM], CTD-related) vasculitis (CryoVas) in remission post RTX induction. W/ 58 mos F/U Relapse rates were 23%, 42%, 71% (@ 1yr, 2yrs, 5yrs). Relapse risk w/ purpura [HR 2.2] & prior CryoVas flare (HR 1.9). https://t.co/6zGgSN8Wfe
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RA leads to ILD: but ILD does not lead to RA

Rheumatoid arthritis is a common autoimmune disease, and approximately 30%-40% of patients develop pulmonary complications such as idiopathic pulmonary fibrosis (IPF), but the causal relationship between the two has long been unclear.

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Full read overview of Immune Checkpoint Inhibitors and their downside - immune related Adverse Events https://t.co/h1AzFaGVMz https://t.co/s75UdhE1HK
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Pipeline of drugs being developed for Scleroderma by these companies - Bayer, Novartis, GSK, Boehringer Ingelheim, Celgene Corp., Johnson & Johnson, Prometic, Cytori arGentis - either as fusion proteins, peptides, small molecule, mAb, Polymern& Gene therapy https://t.co/dWRcQ1a3GU
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Rheums Speak - RA Treatment Survey

RheumNow's August 2025 “Live Vote” surveys examine Rheumatologist impressions, knowledge and practices over the last 20 years when treating rheumatoid arthritis.

The first survey on RA Treatment (7/28/2025) sheds light on evolving prescribing habits, use of biologics, and key frustrations in RA

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FDA Approves Vagal Nerve Stimulator for RA SetPoint Medical announced the FDA approved the SetPoint System, a neuroimmune modulation treatment for moderate-to-severe rheumatoid arthritis (RA), for patients not well-managed or cannot tolerate—existing RA therapies like https://t.co/McheSz30dl
Dr. John Cush @RheumNow( View Tweet )

A New RA Approval (8.1.2025)

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

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Rituximab is not Superior in EGPA A cohort study of Eosinophilic Granulomatosis With Polyangiitis (EGPA) patients from the French Vasculitis Study Group failed to show superiority of rituximab compared to conventional strategy with glucocorticoids (GS) alone or in combination https://t.co/h4B20Ngamj
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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/KN7ZZ2LWPW
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TriNetX study of E-health record study of ~53k transcatheter aortic valve intervention (TAVI) pts. 705 were on preoperative colchicine - these had signif reduction of post-TAVI heart block and AV/LBBB (RR 0.867 [95% CI, 0.756–0.994]) @ 1 month, but not at 6 months https://t.co/wuwlzE22q2
Dr. John Cush @RheumNow( View Tweet )

FDA Approves Vagal Nerve Stimulator for RA

SetPoint Medical announced that the FDA has approved the company’s SetPoint System, a first-in-class neuroimmune modulation innovation for treatment of moderate-to-severe rheumatoid arthritis (RA) for those who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such

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Options for Refractory axSpA or PsA

MedPage Today

Although most patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) didn't respond adequately to the interleukin-17 (IL-17) inhibitor ixekizumab (Taltz), enough did that it should still be considered in such cases, a Danish registry study indicated.

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Danish childhood vaccination registry study (1997-2020) found among 1,224,176 children w/ vaccination before age 5, w/ aluminum containing vaccines against an DPT, poliovirus, Hib (DTaP-IPV/Hib), PCV, etc found no increased risk of autoimmune dz by 8 yrs of https://t.co/9IR6AmlIT9
Dr. John Cush @RheumNow( View Tweet )

Rituximab is not Superior in EGPA

A cohort study of Eosinophilic Granulomatosis With Polyangiitis (EGPA) patients from the French Vasculitis Study Group failed to show superiority of rituximab compared to conventional strategy with glucocorticoids (GS) alone or in combination with cyclophosphamide.

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RHEUM Survey: Starting a new biologic agent in RA, when do you expect to see a good response? CLICK HERE>> https://t.co/NBXu4cNLVj a.6 weeks b.3 months c.4 months d.6 months e.With adverse events

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CKD & Osteoporosis Rx Revisited (7.25.2025) Dr. Jack Cush reviews the news, journal and FDA updates from this past week on RheumNow. https://t.co/k78DRpWIJS https://t.co/aYKvIhmJN1
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HCQ Preserves Renal Function in Lupus Nephritis

MedPage Today

Lupus nephritis patients on long-term therapy with hydroxychloroquine showed significantly less decline in renal function, compared with patients treated otherwise, a 10-year retrospective study indicated.

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Factors Affecting Biologic Use in Rheumatoid Arthritis

A San Francisco Rheumatoid Arthritis Panel cohort survey between 1999–2011, showed numerous sociodemographic, disease, and health characteristics that influenced the initiation of treatment with biologic agents for rheumatoid arthritis (RA).

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Review of risankizumab efficacy & safety included 545 psoriasis pts showing Mean PASI decreased from 14 to 0.5 at 208Wk. PASI100 achieved in 33% and 74% at 16Wk & 208Wk. Bio-naïve responded faster bio-experienced pts - only 5 pts D/C for adverse events https://t.co/VklLWpD0SF https://t.co/zZfuiFijd4
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Practical management of rheumatic immune-related adverse events with immune checkpoint inhibitors Joint Bone Spine has published a full read review of the management of immune-related adverse events (irAEs) in patients receiving Immune checkpoint inhibitors (ICIs) for cancer. https://t.co/i3FMOCbyNg
Dr. John Cush @RheumNow( View Tweet )

CKD & Osteoporosis Rx Revisited (7.25.2025)

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

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Practical management of rheumatic immune-related adverse events with immune checkpoint inhibitors

Joint Bone Spine has published a full read review of the management of immune-related adverse events (irAEs) in patients receiving Immune checkpoint inhibitors (ICIs) for cancer.
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FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026) https://t.co/kVFAz9ltlr https://t.co/LqdzsXlqER
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