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Pharma/Regulatory

Legal (Not So) Merry-Go-Round of Alendronate Atypical Fractures

Dr. Gregory Curfman, MD (Executive editor of JAMA) writes on the chronological legal progress of a lawsuit stemming from rare instances of atypical femoral fractures associated with bisphosphonate (alendronate) use. While alendronate was FDA approved in 1995 for the prevention and

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Small-molecule Drugs to Treat Systemic Lupus Erythematosus

A metanalysis of randomized controlled trials (RCTs) on treatments of systemic lupus erythematosus (SLE), confirm the efficacy of several targeted small-molecule drugs. 

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Systemic Inflammation and Mortality in RA-ILD

Analysis of the German RABBIT registry shows that systemic inflammation, more so than disease activity, strongly influences all-cause mortality in patients with rheumatoid arthritis and prevalent interstitial lung disease (RA-ILD).

RA-ILD patients from the biologics register Rheumatoid

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ARCTIC Rewind: Can You Taper DMARDs with Remission?

In an open-label, randomized, non-inferiority trial, rheumatoid arthritis patients in remission were subject to tapering of disease-modifying antirheumatic drugs (DMARDs), and while maintenance of remission was seen in some, many DMARD tapering patients did flare and were unable to maintain

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Predicting CKD Outcomes in Lupus Nephritis

An observational cohort study suggests that proteinuria levels in lupus nephritis (LN) patients did not predict their histologic class.

A multicentre observational study of patients with biopsy-proven LN; either proliferative (PLN) or membranous (MLN) lupus nephritis were compared regarding

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Self Acupressure in Knee Osteoarthritis

A clinical trial has shown that self-administered acupressure (SAA) is effective in relieving knee osteoarthritis (KOA) patients.

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What a racket! Pharmacy benefit managers make billions collecting fees from payers & rebates from Pharma. 2022, these 3 (CVS Caremark, Express Scripts, OptumRx) control 79% of PBM market.Why is Congress dragging their feet here? Overview read from Reuters https://t.co/m5AnMFtEhf https://t.co/m5EwfcNMdo
Dr. John Cush @RheumNow( View Tweet )

Canary in a Coal Mine (4.19.2024)

Dr. Jack Cush reviews regulatory reports, news and novel journal articles - this week focusing on Sjogren's, ILD, Gout and Uveitis.

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SGLT2 Inhibitors Lowers Gout Risks in Type 2 Diabetes

A population-based cohort has demonstrated that sodium-glucose cotransporter-2 inhibitors (SGLT2i) use in gout patients is superior to sulfonylurea therapy in lowering the risk of incident gout and recurrent flares among patients with type 2 diabetes (T2D). 

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Lupus Accelerating Breakthroughs Consortium Partners with FDA

EurekAlert!

The Lupus Research Alliance (LRA), founder and administrator of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), announced today at the Consortium’s first anniversary meeting an expanded partnership with the U.S. Food and Drug Administration (FDA) with the inclusion of the Center

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World Congress on OP, OA & MSK Disorders

EurekAlert!

Bone and musculoskeletal disease researchers and physicians from around the world will meet today in London, UK for the opening of the largest scientific event in the field, the World Congress on Osteoporosis, Osteoarthritis and

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JAMA: SLE Review

Drs. Caroline Siegel and Lisa Sammaritano (from HSS in NYC) have published an impressive overview of systemic lupus erythematosus (SLE) in JAMA. This timely, well-written review covers the many complexities of this multi-organ disorder that affects nearly 3.4 million people worldwide.

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Serious Infections in Takayasu arteritis

The large vessel vasculitis, Takayasu arteritis (TAK), carries a significant morbid risk and a cohort analysis shows these patients are also at high risk of serious infection with resultant higher risk of death.

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Mortality in Psoriatic Arthritis

The Annals of Rheumatic Disease reports that mortality risk in psoriatic arthritis (PsA) is about 10% higher than in the general population, primarily from excess comorbidity and with increased risks in women, with longer disease durations.

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Polycyclic Aromatic Hydrocarbons Increase Lupus Risk

A case-controlled study shows environmental exposure to polycyclic aromatic hydrocarbons (PAH) may increase the risk of developing systemic lupus erythematosus (SLE). 

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CBD Products Disappointing for Pain

EurekAlert!

There is no evidence that CBD products reduce chronic pain, and taking them is a waste of money and potentially harmful to health, according to new research led by the University of Bath in the UK.

CBD (short for cannabidiol) is one of many chemicals found naturally in the cannabis

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13 Risk Factors for RA-associated Interstitial Lung Disease

Interstitial lung disease (ILD) is the most widespread and fatal pulmonary complication of rheumatoid arthritis (RA). A recent metanalysis shows the pooled prevalence of RA-ILD was approximately 18.7%. 

This systematic review included 56 studies with 11,851 RA-ILD patients. The

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Systemic Score Predicts Still's Disease Severe Complications

A multinational study of adults with Still's disease  found that calculating their systemic score at baseline significantly predicted the patients risk for life-threatening outcomes (MAS or death).

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ACR Supports FY 2024 Budget

ACR

The American College of Rheumatology (ACR) today expressed strong support for several key measures included in the Fiscal Year (FY) 2024 budget. The budget allocates crucial funding to the Department of Defense’s Congressionally Directed Medical Research Program (CDMRP) for research on

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Window of Opportunity in Psoriatic Arthritis

A Dutch Early Psoriatic Arthritis cohort study shows that psoriatic arthritis (PsA) patients treated early (referred and diagnosed  within in less than 12 weeks) had the best clinical outcomes. 

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Naysayers & Disrupters (3.22.2024)

Dr. Jack Cush reviews the news and journal reports from the past week - including a few contrary reports on infection, seropositivity and plasmapheresis.

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2023 EULAR Psoriatic Arthritis Recommendations

EULAR has updated its treatment recommendations from the prior 2019 guidelines, since which there have been several newly developed agents. The updated guidance includes 7 overarching principles and 11 recommendations regarding treatment strategy and pharmacological therapies.

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Expert Panel Guidance on Managing Psoriatic Arthritis and Comorbidities

An expert panel has published their consensus guidelines for the management of psoriatic arthritis (PsA) and it's comorbidities in the journal Rheumatology. 

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Top 10 Pharma R&D Budgets in 2023 Pharma budgets have undergone significant changes since COVID. This year Merck & Co. has knocked Roche from previous years of leading in R&D budgets and investments. https://t.co/xx0eKgXaiQ https://t.co/tMrFlatoMk
Dr. John Cush @RheumNow( View Tweet )

Infection and Rituximab-linked Immunoglobulin Deficiency

A minority of immune-mediated inflammatory disease (IMID) patients treated with rituximab (RTX) are expected to develop and depressed immunoglobulin (Ig) levels.  A recent cohort analysis suggests that RTX-induced Ig deficiency was not associated with an increased risk of severe

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