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Pharma/Regulatory

Top 10 Pharma R&D Budgets in 2023

Pharma budgets have undergone significant changes coming out of COVID. This year Merck & Co. has knocked Roche from previous years of leading in research and development (R&D) budgets and investments. In 2023 Merck invested a whopping $30 billion in R&D, nearly 51% of their 2023

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Ides of March (3.15.2024)

Dr. Jack Cush has advice for Caesar and the superstitious, and covers pregnancy, platelets, dialysis and vaccinations in Lupus.





  1. Dutch study of 586 RA pts on bDMARDs found more nonserious infections (NSIE) (77/100PYs) than serious infx (SIE)(1.3/100Pys). Upper respiratory

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MMWR: Vaccination and Multisystem Inflammatory Syndrome in Children

CDC

Multisystem inflammatory syndrome in children (MIS-C) is a rare but serious condition typically occurring 2–6 weeks after SARS-CoV-2 infection and characterized by fever and multiorgan involvement.  The current MMWR report shows that MIS-C case numbers have decreased by 98% since 2021.

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US Trends in RA DMARD Use 2017-2021

A trend analysis of DMARDs shows that only half of rheumatoid arthritis (RA) patients are taking DMARDs, and that the COVID-19 pandemic substantially affected DMARD use. Despite numerous DMARD advances and evolving treatment guidelines since 1990, older therapies are still commonly used and

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Again, a High Mortality with Depression and RA

Last week we reported on a Korean study showing a 66% elevated mortality risk in RA patients (n=38,487) with depression. This week, a new report shows depression in RA increases the mortality risk by more

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9 Facts about Leflunomide

Medscape has published an informative review of leflunomide, drawn from Dr. Eric Ruderman’s recent lecture on the subject at the February RWCS meeting in Maui.



Leflunomide was FDA approved in 1998 for rheumatoid arthritis, roughly around the same time infliximab and etanercept

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JAMA Review of DMARD Use in Rheumatoid Arthritis

JAMA has reviewed the "2022 EULAR Recommendations for the Management of Rheumatoid Arthritis With Synthetic and Biological Disease-Modifying Antirheumatic Drugs". 

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Mixed Long-term Effects of Calcium and Vitamin D in Postmenopausal Women

A follow-up analysis of a randomized clinical trial found that the use of calcium and vitamin D supplements among postmenopausal women was associated with decreased risk for cancer mortality, but increased risk for cardiovascular disease (CVD) mortality. The analysis is published in 

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Depression and RA (3.8.2024)

Dr. Jack Cush reviews the news, journal reports and regulatory approvals from the past week.

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19% Arthritis Prevalence in the USA

According to the National Health Interview Survey (NHIS), in 2022, the prevalence of diagnosed arthritis in adults was 18.9% (women 21.5%, more than men 16.1%). These numbers are down since the CDC's MMWR report of 2019–2021, where is was estimated 21.2% of U.S. adults (53.2 million) had

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Can Mycophenolate be Stopped in Stable SLE?

In patients with clinicall stable systemic lupus erythematosus (SLE) and lupus nephritis, the withdrawal of mycophenolate mofetil was not significantly inferior to mycophenolate maintenance, but MMF withdrawal had numerically more reactivations, while MMF maintenance had more infections.

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Sniffles & Arthritis (3.1.2024)

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. Are these associations with infection, biomarkers and weather real or imaginary? Linked or luck? Causal or casual?  You decide....





  1. No clear link between weather & MSK symptoms

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Many with Psoriatic Arthritis Fail to Achieve Minimal Disease Activity

Despite the availability of numerous advanced therapies for psoriatic arthritis (PsA), there remains a substantial burden and unmet need for improved therapies, according to a newly published Canadian study.

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Excess Cardiovascular Risk in Gout

A UK population cohort study has shown that gout carries an increased risk for a wide variety of cardiovascular disorders.



A matched case–control study examined the electronic health records from the UK Clinical Practice Research Datalink and compared gout (one to five) with controls

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Immunosuppression Increasing (2.23.2024)

Dr. Jack Cush reviews the news and journal reports from the past 2 weeks on RheumNow.com; but begins with a discussion of what constitutes "immunosuppression" and how it applies to our patients.





  1. 2021 NHIS Survey data suggests the prevalence of immunosuppression in the USA

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CD19 CAR T-Cell Therapy in Autoimmune Disease

The NEJM has published the results of CD19 B cell depletion (by CAR-T cell therapy) in autoimmune disease patients, demonstrating it to be feasible, safe, and efficacious.



The rationale to CD19 CAR-T cell transfer is to reset aberrant autoimmunity via deep depletion of B cells with

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ARIAA Trial: Abatacept Delays the Onset of RA

The ARIAA trial tested the utility of IV abatacept in individuals ACPA+ arthralgia patients with subclinical inflammation and showed abatacept to decrease MRI inflammation, clinical symptoms, and risk of future rheumatoid arthritis (RA) development.

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APIPPRA Trial: Abatacept in at-risk rheumatoid arthritis patients

Abatacept has been studied in seropositive clinically suspect arthralgia patients (at risk for rheumatoid arthritis) and shows the potential to delay or prevent the disease. 



Individuals with serum antibodies to citrullinated protein antigens (ACPA), rheumatoid factor, and

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VITAL Info on Autoimmune Disease (2.9.2024)

Dr. Jack Cush reviews the journal reports from the past week on RheumNow.com. Highlights are summarized by three songs: "Stairway to Heaven", "You're No Good", and "How Long (has this been going on)".





  1. Many #RA pts remain on Steroids despite b/tsDMARD use! Study 228 #RA pts

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Racial and Ethnic Determinants of Psoriatic Arthritis

A study from a large metropolitan registry of psoriatic arthritis (PsA) patients showed several racial and/or ethnic groups are underrepresented and demonstrate differences in disease activity.

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Pre-Treatment Testing with Biologics Falls Short

US commercial insurance claim analysis of laboratory screening and monitoring practices in chronic inflammatory skin disease (CISD) patients shows that < 60% received the recommended pretreatment testing when starting systemic immunomodulatory treatment.

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Prevalence of Cardiovascular Disease in Rheumatoid Arthritis

A prospective study of the BioSTAR registry estimates the prevalence of cardiovascular disease in rheumatoid arthritis (RA) to be 4.6%.

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ACR Applauds Prior Authorization Rule

ACR

The American College of Rheumatology (ACR), on behalf of over 9,100 rheumatologists and rheumatology professional team members, applauds the Centers for Medicare and Medicaid Services (CMS) for finalizing its Advancing Interoperability and Improving Prior Authorization Processes for Medicare

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Severe Hypocalcemia Risk with Denosumab and CKD Patients

On 1-19-2024, the Food and Drug Administration (FDA) issued a Drug Safety Communication about the risk of severe hypocalcemia in chronic kidney disease (CKD) patients taking denosumab for osteoporosis, with an accentuated risk in older women who are dialysis-dependent.

This report is an update

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Methotrexate Nodulosis (1.19.2024)

Dr. Jack Cush reviews the news and journal reports from this past week on RheumNow.com. How good (or not) are rheumatologists and what to do about MTX nodulosis?





  1. Network meta-analyses of 153 trials & 8713 patients w/ chronic pain from TMJ disorders; Most effective (

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