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FDA Final Guidance on Interchangeability with Biosimilars
The FDA has published an industry guidance document to define interchangeability as regards to biosimilar use in the United States under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).
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Dermatology Guidelines for Psoriatic Comorbidities
The JAAD has published joint guidelines from the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) on the approach, management and dermatolgist roles for select comorbid conditions.
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RheumNow Podcast - Death and Surgery (2-22-19)
Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com:
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Lupus Microbiome May Drive Disease Activity
Silverman and colleagues have published their study of the fecal microbiome of systemic lupus erythematosus (SLE) patients and found roughly five times more gut bacteria known as Ruminococcus gnavus, and that these abnormalities in microbiota can correlate with measures of disease severity i
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Safety Warnings for Higher Dose Tofacitinib
Pfizer has issued a press release regarding the safety of tofacitinib, citing higher rates of pulmonary embolism and death associated with the use of higher dose tofacitinib 10mg bid in rheumatoid arthritis (RA) patients treated in a long-term safety trial.
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RheumNow Podcast - Scurvy and Mechanics (2-1-19)
Dr. Jack Cush reviews new journal articles, news reports, and more from the past week on RheumNow.com.
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Low IBD Risk with Secukinumab
The interleukin-23 (IL-23)/IL-17 axis plays an important role in inflammation and infection. Some of these chronic immune-mediated inflammatory disorders include PsO, PsA, AS, and IBD. Patients with PsO, PsA, and AS have up to a four-fold risk of developing IBD versus the general population.
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Hepatic Safety of Urate Lowering Therapies in Gout
Lee and a group of Korean investigators have analyzed the comparative safety of allopurinol and febuxostat in a small cohort of gout patients with fatty liver disease (FLD) and found febuxostat had a lower risk for hepatotoxicity (defined as AST or ALT at least 3× the upper limit of normal)
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RheumNow Weekly Podcast – 3 Wiseguy Rheumatologists (11.9.18)
Dr Jack Cush reviews the News and Journal reports from the past week on RheumNow.com. Be sure to check out our upcoming meeting in March 2019 - RheumNow Live.
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Low Short-Term Risks of NSAIDs in High Risk Patients
JAMA has published a large Canadian claims-based study showing that nonsteroidal anti-inflammatory drug (NSAID) use in patients with hypertension, heart failure, or chronic kidney disease was not associated with a significant safety risk - but this only looked at short-term outcomes (7-3
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NSAIDs OK for Certain High-Risk Groups?
Some patients typically contraindicated for prescription nonsteroidal anti-inflammatory drug (NSAID) use may be able to take them with no increased risk of harm, according to a large observational study.
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An Association between GCA and IBD ?
A population based analysis from Israel suggests that giant cell arteritis (GCA) patients may be at increased risk for inflammatory bowel diseases (IBD) mainly target.
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Out of Pocket Costs for Biosimilars - No Savings So Far
JAMA has published an analysis showing that under Medicare Part D, RA biosimilar infliximab-dyyb was only moderately less expensive (18% less) than the biologic infliximab and, owing to differences in gap discounts, the out of pocket costs for the biosimilar was nearly $1700 more than infliximab
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Liver Disease Increased in Psoriasis
An observational case-control study has shown that psoriasis is associated with an increased prevalence of nonalcoholic fatty liver disease (NAFLD).
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EULAR 2018 - Day 4 Report
The EULAR 2018 wound down on Saturday with fewer oral presentations but many posters. In my last report I put together a collection of impressions and some thematic highlights not covered in previous reports.
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Vedolizumab Implicated in Exacerbations of SpA in IBD Patients
Beloved by gastroenterologist for treatment of inflammatory bowel disease (IBD), α4β7 integrin receptor vedolizumab (VDZ) has probably caught attention of many rheumatologist since the time it entered the market; largely for what it won't do for inflammatory arthritis.
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The Microbiome and Lupus Connection Reviewed
In the current issue of the New England Journal of Medicine, Drs. James Rosenbaum and Gregg Silverstein review the pathogenesis of systemic lupus erythematosus (SLE) from the viewpoint of a dysbiolsis.
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The RheumNow Week in Review – Good News for GPA, CZP, Tofa but not ERA (6.1.18)
Dr. Jack Cush reviews this weeks reports from RheumNow.com, including the risk of autoimmunity with vaccination, early RA outcomes, new FDA approvals for certolizumab and tofacitinib and the risk of death from infection with biologics.
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High anti-TNF Failure Rates with Obesity
A meta-analysis has suggested that obesity is an under-reported predictor of inferior response to tumor necrosis factor blockade (anti-TNF) in a range of inflammatory immune-mediated inflammatory diseases (IMIDs), with the results showing a 60% risk of impaired response to anti-TNF across several
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Increased Comorbidity Burden in Lupus African Americans
Researchers from Vanderbilt University Medical Center used electronic health records (EHR) to perform a phenome-wide study comparing African American (AA-SLE) and Caucasian (C-SLE) with systemic lupus erythematosus (SLE) and found more comorbidities in AA-SLE, especially renal, cardiovascular, an
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