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New Avacopan Analysis Sent to FDA

MedPage Today

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 in a bid to keep the embattled drug for severe anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis on the market.

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Tips for safe use of allopurinol

These are tips and hopefully the patients are abstaining from moderate alcohol and are not tipsy! Here are 5 tips that may not be totally obvious.

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"The best medicine I know for rheumatism is to thank the Lord that it ain't the gout." — Josh Billings (Henry Wheeler Shaw)

Dr. John Cush @RheumNow (  View Tweet)

Evidence-Based Dietary Recommendations for Gout Gout, historically referred to as the “disease of kings,” was once associated with a lifestyle of excess. Today, it is more appropriate to refer to gout as a “disease of commoners,” as it is the most common inflammatory arthritis https://t.co/uIrSeOjxJZ
Dr. John Cush @RheumNow (  View Tweet)
3 Rx are FDA approved for hidradenitis supprativa (secukinumab, adalimumab, bimekizumab). New JAK1i Povorcitinib in STOP-HS1 and STOP-HS2 ph 3 PCTs (608/619 pts). Povo showed HiSCR50 ~42% vs PBO 29% @wk12. AE: acne, pharyngitis https://t.co/n3FJUOjNuo https://t.co/9YAmPqW44z
Dr. John Cush @RheumNow (  View Tweet)
Interferon-α as an Immunologic Driver of Sjögren's Disease Using data from a Sjogren's registry, researchers have shown that IFNα drives Sjögren's disease, and can be elevated a decade before diagnosis. This study assessed the role of type 1 interferon (IFNα) in its onset and https://t.co/0BDDvR5cUB
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Genetic Risk Loci in Fibromyalgia

Researchers examined genetic data drawn from 11 different worldwide cohorts, that included from more than 2.5 million adults, of which 55,000 had been diagnosed with fibromyalgia. They identified DNA sequence variants in 26 regions of the genome that affect the risk of developing fibromyalgia. Many of the genes implicated in these regions are involved in brain and nerve function. This is the largest fibromyalgia GWAS to date.

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Uricase-Targeted Therapies in Gout

In most mammals, uricase catalyzes the oxidation of uric acid to allantoin, a highly soluble compound easily excreted by the kidneys. But humans lack functional uricase, leaving xanthine oxidase inhibitors (allopurinol/febuxostat) as first-line urate-lowering therapy (ULT). Uricase-based biologics are reserved for uncontrolled/refractory gout patients with gouty flares, active synovitis, and/or non-resolving tophi despite optimized oral

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Persistence of education and monitoring is crucial to optimal gout management Optimal gout care is dependent on having a well-informed health care provider who recognizes and follows the ACR gout management recommendations. It is important that the misconceptions and myths held https://t.co/wDvgwUg2P1
Dr. John Cush @RheumNow (  View Tweet)
Pragmatism in Gout: How therapeutic choices can have multiple benefits Drugs prescribed to calm flares or lower uric acid are designed with one primary goal in mind, yet many also produce meaningful effects beyond the joints. Some of those secondary effects are unwelcome; such https://t.co/QvXAwFM7LJ
Dr. John Cush @RheumNow (  View Tweet)
Retrospective study of 2187 RA pts initiating menopausal hormone Tx (MHT) vs 8,205 unexposed controls. VTE incidence higher among MHT users (6.49 vs 3.3/1000PY). MHT use was associated with a 92% signif increased risk of VTE in RA (adj HR: 1.92), mostly DVT risk (aHR: 2.26)

Dr. John Cush @RheumNow (  View Tweet)

Future therapies (in development) for gout - the goal is durable crystal depletion. Created by: Dr. Aravind Palraj @rheumat_aravind for RheumNow. https://t.co/rzP8usVZnT https://t.co/ZDuVWqT2TA
Dr. John Cush @RheumNow (  View Tweet)
Psoriasis = Myocardial Dysfunction (unrelated to Cardiometabolic Risk Factors) 1010 PsO pts vs controls w/o skin dz, assessed clinically & by ECHO. PSO pts (even w/ controlled dz) had signif more myocardial dysfunction (17% vs 6%). Higher BMI & DM independently assoc w/ https://t.co/MjcRmgyCWX
Dr. John Cush @RheumNow (  View Tweet)

The Wider Implications of Dactylitis

Dactylitis, AKA the "sausage digit", is a hallmark of psoriatic arthritis (PsA), but as Possemato and colleagues point out, it is fundamentally a clinical sign, and not a diagnosis. This review article discusses the wider implications of dactylitis in rheumatology and medicine underscores the diagnostic and prognostic significance of this manifestation.

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STOP-HZ trial - 30 #RA pts going on tofacitinib given Shingrix (RZV) on day 1 & wk 8 & started Tofa on d1 or wk8. @wk 12 VZV responses incr in both (2.66 & 2.91 fold incr). @wk 4, d1 Tofa had fewer ≥1.5-fold VZV vs wk8 (44.8% vs 80%); BUT can you wait 8wks to start JAKi? https://t.co/tH0zPgBbHQ
Dr. John Cush @RheumNow (  View Tweet)
Calcium Pyrophosphate Deposition Dz new terminology from 2026 G-CAN consensus. Preferred: - acute CPP crystal arthritis - Chronic CPP crystal arthritis - Chronic CPP crystal arthritis - OA w/ CPP - Chondrocalcinosis (xray) * Pseudogout is obsolete https://t.co/L95N2ObHr3 https://t.co/ST7RkJa8BR
Dr. John Cush @RheumNow (  View Tweet)
An AI model trained from routine electronic health record data of 3.7 million individuals predicted cancer 1 year before clinical onset, no less promoted accuracy in detection, staging, treatment response, and prognosis https://t.co/ORrpJ2vIcR https://t.co/ymJWRAYOSw
Eric Topol @EricTopol (  View Tweet)
UTSW observational study of labs (n 14,199) changes w/ MTX use in 2,439 pts (13% RA, 11% PsO/PsA, 15% inflam arthritis) - found no difference in labs q3 vs q6 mos. No signif correlation betw monitoring intervals & changes in ALT, AST,WBC, HCT, MCV, PLT, FIB-4. Small https://t.co/gKwA7juexG
Dr. John Cush @RheumNow (  View Tweet)
RHEUMS! FINAL GOUT SURVEY ON NEW THERAPIES>> Which biologic is FDA-approved for gout? Answer here>> https://t.co/MWSnCZEDdR

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