Pharma/Regulatory

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APEX Study: Inhibition of structural damage progression with Guselkumab in Psoriatic Arthritis

Jack Cush, MD

Guselkumab, a human IL-23 inhibitor, was evaluated in patients with active psoriatic arthritis (PsA) and shown to have both clinical and radiographic benefits at weeks 24 and 48.

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Japanese ANSWER cohort (3623 RA pts on bDMARDs or JAKi) included looked at T2T in 118 RA pregnancies. 93% had full-term deliveries; 85% w/ remission or LDA maintained throughout preg. 35/118 cont' bDMARDs during preg & had signif lower DAS28-CRP vs those D/C (n 24) (P = 0.007). https://t.co/uG8m7RzSiU
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Australian Vaccine study (2019 - 2021) - w/in 12 mos of b/tsDMARD initiation 73% (11,225/15,460) recv influenza vaccination. High-dose Flu vax used in 28% in 60–69 yo, but > 80% older than 70yo. Only 9.7% recv pneumococcal & 2.4% zoster Zostavax or Shingrix) vax w/in 6 months of https://t.co/xoGTWMUi1L
Dr. John Cush @RheumNow( View Tweet )
USA,States,map

Rheumatology Supply and Demand (2009 - 2024)

Jack Cush, MD

A retrospective review of US rheumatology manpower and training between 2009 and 2024 shows that US rheumatology training has become competitive with an increasing surplus of applicants compared to available training positions, which have also increased over time.

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Treating During Pregnancy (11.14.2025) | RheumNow https://t.co/sTv7O6YcnA https://t.co/KT0qGFJu0O

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Dr. John Cush @RheumNow( View Tweet )
Postmenopausal women on estrogen hormone therapy (HT) had a modest incr risk (HR 1.33; 1.32-1.35; P < .001). of a new autoimmune Dz over next 5-10 yrs (vs those not on HT) TriNetX study of 889,413 HT vs 2,6 mill (not HT) - 6.7% vs 5.3% developed autoimmune dz at 5 yrs. https://t.co/fsi32XIzLe
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GLP-1 Receptor Agonists in PsA: Mortality and MACE Dr. Antoni Chan reports on abstract 0849 (Mortality and Major Adverse Cardiac Events (MACE) with GLP-1 Receptor Agonists in Psoriatic Arthritis), presented at #ACR25. https://t.co/XNyt3UIjgp https://t.co/RUnZCjXF9T

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Dr. John Cush @RheumNow( View Tweet )
Tocilizumab Beats Methotrexate in GCA Dr. Mike Putman reports on abstract 0891 (MEthotrexate versus TOcilizumab for treatment of Giant cell Arteritis (METOGiA trial): a multicenter, randomized, controlled trial), presented at the #ACR25. https://t.co/IeCWZGupqR https://t.co/SCF1guorMs

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Dr. John Cush @RheumNow( View Tweet )
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Treating During Pregnancy (11.14.2025)

Jack Cush, MD

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

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Why I love the late breaking abstracts https://t.co/jCSfNOoFeT https://t.co/uZWSm9SQAI

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Dr. John Cush @RheumNow( View Tweet )
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DAHLIAS study - Nipocalimab in Sjögren's Disease

Jack Cush, MD

Nipocalimab, a neonatal Fc receptor blocker that reduces circulating IgG and autoantibodies, was shown to be effective in a phase 2 trial in patients with severe Sjögren's disease.

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Genentech announced positive results from the phase III DBRPCT ALLEGORY trial showin safety & efficacy of obinutuzumab in ~300 SLE pts on SOC. Results have yet to be presented publicly. https://t.co/4hoT9dBtPq

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Tapering in SELECT GCA: Steroids are the Problem Dr. Mike Putman reports on abstract 0895 (Impact of Glucocorticoid Tapering in Giant Cell Arteritis: Analysis From the SELECT-GCA Trial) presented at #ACR25. https://t.co/80Bl49uImB https://t.co/GjlHHjPW2u

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Dr. John Cush @RheumNow( View Tweet )
IL-23 Blockade Goes Oral A new player is entering the IL-23 arena — and it’s a tablet! Icotrokinra (ICO), a first-in-class peptide that binds and blocks the IL-23R, is showing encouraging efficacy and safety across a range of psoriasis (PSO) and psoriatic disease (PsD) studies. https://t.co/MyqCjilYGL
Dr. John Cush @RheumNow( View Tweet )
ACR, guidance, guidelines

New ACR 2025 Guidelines for Non-Renal Lupus

MedPage Today

Written by Lisa Sammaritano, MD, of the Hospital for Special Surgery in New York City, and a committee of nearly 50 other experts, the new guideline also stipulates that corticosteroids are OK for gaining symptom control in newly diagnosed patients and when flares erupt, but the duration should

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B Cell Depletion: Check the Lymph Node Dr. Akhil Sood reports on abstract 2695 (B-cell depletion and lymphoid follicle disruption upon different B-cell depleting agents) presented at #ACR25. https://t.co/bvZMGWNzfe https://t.co/dB6iQlgoYx

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Dr. John Cush @RheumNow( View Tweet )
Stopping therapy in GCA At #ACR25 we saw the SELECT-GCA extension data presented in the first plenary session, looking at the second year after the 52 week original study, comparing upadacitinib versus placebo in GCA. In this second year, patients in remission on upadacitinib https://t.co/GaYNWr3Sjq
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Belimumab Before or After Immunosuppressant Dr. Yuz Yusof reports on abstract 0803 presented at #ACR25 https://t.co/BVFhDDfTvW https://t.co/F9ZvGXIqVn

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Using AI and LLMs in Qualitative Data Dr. Bella Mehta discusses abstract 0794 (Using AI to Analyze Multilingual Qualitative Data in Lupus Pregnancy Research: A Proof of Concept with Large Language Models) presented at #ACR25 https://t.co/HFBuNxdZOF https://t.co/gKAXURq8xR

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Nerandomilast for ILD Dr. Mike Putman reports on abstract 1662 (Efficacy and Safety of Nerandomilast in Patients with Autoimmune Disease-Related Progressive Pulmonary Fibrosis: Subgroup Analysis of the FIBRONEER-ILD trial). #ACR25 https://t.co/J0e4SbVgFE https://t.co/dlOM700yVQ

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Dr. John Cush @RheumNow( View Tweet )
Are we putting the CAR-T before the horse? CAR T-cells have been a revolutionary development in rheumatology. We have seen a population of patients with severe refractory autoimmune conditions almost overnight presented with the prospect of not just improvement, but of a cure. https://t.co/niPU5cAojP
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Marketscan claims study of 62,813 IMID women w/ 70,529 pregnancies & 69,412 births, 4,485 (7.1%) were exposed to at least one TNFi during pregnancy & 3,559 postpartum. TNFi use NOT assoc w/ SIE risk during Preg (HR 1.39; 0.95-2.05) or postpartum (HR 1.22; https://t.co/NsxOLpT0ds
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B Cell Depletion: Check the Lymph Node Dr. Akhil Sood reports on abstract 2695 (B-cell depletion and lymphoid follicle disruption upon different B-cell depleting agents) presented at #ACR25. https://t.co/BjgIC3Kng0 https://t.co/flfyLZYW8q

Links:

Dr. John Cush @RheumNow( View Tweet )
Psoriatic Arthritis: Which biologic agent is the best first choice? A growing arsenal of therapeutic targets in psoriatic arthritis (PsA) has enhanced the landscape of treatment in patients with this disease. https://t.co/pRMyPCvMrN https://t.co/nOgnf5F3Pw

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Dr. John Cush @RheumNow( View Tweet )
Topline results of ALLEGORY study (Genentech) - 300 pt. phase 3 DBRPCT obinuntuzumab vs PBO in active SLE w/ SRI-4 primary outcome at wk 52. The anti-CD20, B-cell depleter, Rx met all efficacy endpoints primary and all key secondary endpoints. Gazyva was FDA approved last wk https://t.co/Wd6EFEjvGP
Dr. John Cush @RheumNow( View Tweet )

Recent Blogs

Choice Overload (and the Way Out)

Jack Cush, MD
paint,choice,overload,color
I recently overheard a very good practicing rheumatologist complain, “why do I need yet another drug for psoriatic arthritis? I have more treatment choices than I have actual PsA patients who need a new or better drug”. Read Post

Best of 2022: Methotrexate in PsA

Philip Mease, MD
Methotrexate
Until the publication of the SEAM trial, evidence in the medical literature for the efficacy of the most commonly used drug for psoriatic arthritis worldwide, methotrexate, has been lukewarm at best. Yet we all employ it commonly, either as monotherapy or in combination with biologic or targeted synthetic DMARD treatment. It is inexpensive and widely available, and only modestly toxic. Read Post
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