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Pharma/Regulatory

FDA Approves Brepocitinib to Treat Dermatomyositis

The FDA and Priovant recently annouced approval of brepocitinib (Lisraya), a JAK1/TYK2 inhibitor, for the indication of adults with dermatomyositis (DM). This is the first oral (once daily) agent approved for DM.

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CAR-T Reality Check! The hype is outrunning the evidence, which now lives in a handy dashboard created and presented by Dr. Mike Putman @EBRheum. There are almost as many studies as there are CAR-T treated patients. Few numbers, limited F/U - Yet everyone is gaga about CAR-T. https://t.co/6tLLJDVI8x
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NME: New Molecular Entities (8.28.2026)

Dr. Jack Cush reviews the news and journal articles from this past week on RheumNow.com. Take this week's RheumIQ and test your knowledge!

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Phase 1/2 COMPARE trial of CD19 CAR-T Rx in 6 ACPA+ RA pts w/ severe refractory Dz; after lymphodepletion, given mivocabtagene autoleucel (miv-cel), followed < 52wks. All had CRS, No ICANSs or serious AEs. All had CD19 cell depletion & Decr in AutoAbs. Efficacy: 3/6 had ACR70 & https://t.co/qfSdq2g0rk
Dr. John Cush @RheumNow( View Tweet )

Secukinumab in Polymyalgia Rheumatica

Polymyalgia rheumatica (PMR) is a common disorder of the elderly that responds well to glucocorticoids (GC), but is plagued by an inability to wean off of GCs.
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Insights into Sjögren’s Disease - A Rheum Survey

RheumNow recentlty surveyed rheumatologists about Sjogren’s disease (SjD) - how they approach diagnosis, treatment, and unique challenges; all important as new advances in SjD evolves.

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Brepocitinib Skin Outcomes in Patients With Dermatomyositis

A secondary analysis of the VALOR trial has shown that the TYK2/JAK1 inhibitor brepocitinib was effective at cutaneous disease activity outcomes, delivering rapid, clinically meaningful, and remission-level control of cutaneous dermatomyositis (DM).

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CAR-T Reality Check! The hype is outrunning the evidence, which now lives in a handy dashboard created and presented by Dr. Mike Putman @EBRheum. There are almost as many studies as there are CAR-T treated patients. Few numbers, limited F/U - Yet everyone is gaga about CAR-T. https://t.co/aCtA8il2fD
Dr. John Cush @RheumNow( View Tweet )
Registry Data Shows Liver Risk With Avacopan A new study may add fuel to the fire already burning around avacopan (Tavneos), approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), which the FDA wants drugmaker Amgen to pull from https://t.co/nHF6RVpq2Z
Dr. John Cush @RheumNow( View Tweet )

Age-specific Incidence of Systemic Lupus Erythematosus

Epidemiologic estimates on systemic lupus erythematosus (SLE) diagnosis are limited. The Centers for Disease Control and Prevention (CDC) National Lupus Registry network of population-based SLE registries has assessed and reported age-specific incidence of SLE

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JAK inhibitor Drug Market size (worldwide) was valued at $ 5.51 Billion in 2024 & is estimated to reach $ 19.81 Billion by 2033, exhibiting a Compound Annual Growth Rate of 13.66% from 2026-2033. https://t.co/1Krd1TeKv1 https://t.co/k0hx7iXTvn
Dr. John Cush @RheumNow( View Tweet )

Registry Data Shows Liver Risk With Avacopan

MedPage Today

A new study may add fuel to the fire already burning around avacopan (Tavneos), approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), which the FDA wants drugmaker Amgen to pull from the U.S. market.

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EU Finalizes Tavneos Withdrawal - The European Commission has officially revoked the marketing authorization for Tavneos (avacopan), finalizing a process that began with regulators flagging the drug's pivotal trial data as "incorrect and misleading." The EC issued its legally https://t.co/jgysiV1hyX

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Doubting RS3PE (8.14.2026) Dr. Jack Cush reviews the news and journal articles this week where RheumNow featured info on cancer, deadly viruses, AI rules, poetry and good moons rising. https://t.co/gmcrjb5bDu https://t.co/LiLl7XcZQS
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Review of CAR-T 29 trials in systemic sclerosis (SSc): 27/29 target CD19 (other CD20, BCMA), 20/29 autologous. Only 2 RCTs; 1 w/ RTX comparator. Most included CREST. Schetts largest series had 6 dcSSc w/ skin/lung improvements. Need fewer & larger multicenter RCTs https://t.co/Me28HbaFhR
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Efgartigimod Efficacy in Idiopathic Inflammatory Myopathy

Today Argenx announced the results of their Phase 3 "ALKIVIA" study; demonstrating efficacy and safety of subcutaneous efgartigimod for Idiopathic Inflammatory Myopathy (IIM, AKA inflammatory myositis).

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JAMA has updated its guidance for the acceptable use of AI in authoring a Medical Publication. Despite growing AI use, very low rates of disclosure of AI use have been reported. This is about what is permitted & not permitted & what needs to be disclosed. https://t.co/zti0OnvBV0 https://t.co/6VHiEPGxUf
Dr. John Cush @RheumNow( View Tweet )
Updated Guidance for Artificial Intelligence Use in Medical Publications JAMA has updated its guidance for the acceptable use of artificial intelligence (AI) in authoring a medical publication. Despite growing AI use, very low rates of disclosure of AI use have been reported. https://t.co/irid5koIjo
Dr. John Cush @RheumNow( View Tweet )

ZEUS Trial: IL-6 Inhibition Fails to Cut Cardiovascular Events

The phase 3 ZEUS trial (published in JAMA Dec. 2025)  tested the IL-6 ligand inhibitor ziltivekimab in over 6,000 patients with atherosclerotic cardiovascular disease, chronic kidney disease, and elevated hsCRP—a population enriched for an inflammatory driver of risk.

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2026 BSR Pain Guideline: What Rheumatologists Need to Know

The British Society for Rheumatology has issued its first guideline dedicated solely to pain in inflammatory arthritis (IA)—covering RA, PsA, axial SpA and JIA.

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Updated Guidance for Artificial Intelligence Use in Medical Publications

JAMA has updated its guidance for the acceptable use of artificial intelligence (AI) in authoring a medical publication. Despite growing AI use, very low rates of disclosure of AI use have been reported. This update provides specific information about what is permitted and not permitted, and

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JAMA has updated its guidance for the acceptable use of AI in authoring a Medical Publication. Despite growing AI use, very low rates of disclosure of AI use have been reported. This is about what is permitted & not permitted & what needs to be disclosed. https://t.co/zti0OnvBV0 https://t.co/Y1C3MfJ27c
Dr. John Cush @RheumNow( View Tweet )

What's New in Lyme Disease

JAMA has published an overview of new considerations on Lyme disease, focusing on Diagnostics, Vaccines, and Prevention.

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POETYK PsA-1: Deucravacitinib in Biologic-Naïve PsA

POETYK PsA-1 trial tested the disease modifying efficacy of deucravacitinib, a tyrosine kinase 2 (TYK2) inhibitor, in psoriatic arthritis (PsA) patients and was shown to be superior vs to placebo for clinical responses, patient-reported outcomes, and structural damage inhibition in PsA.

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New Avacopan Analysis Sent to FDA After data manipulation allegations, the FDA has been calling for the vasculitis drug to be pulled from the market since January. Amgen has submitted a third-party review of avacopan's (Tavneos) pivotal trial data and other analyses to the FDA https://t.co/zBg4pFBfSP
Dr. John Cush @RheumNow( View Tweet )
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