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FDA Issues Draft Guidance on Biosimilar Interchangeability
Interchangeability, or the substitution of a biosimilar for its innovator biologic, is on the horizon. Will the prescriber chose the biosimilar in place of the originator? Or will this allow pharmacists or healthcare plans to substitute a biosimilar, without intervention from a healthcare provider?
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The RheumNow Week in Review – 20 January 2017
Dr. Jack Cush reviews highlights from the past week on RheumNow.
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The RheumNow Week in Review – 13 January 2017
Dr. Jack Cush reviews highlights from this past week on RheumNow.com:
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TREG Innovators Win the Crafoord Prize
The 2017 Crafoord Prize from the Royal Swedish Academy of Sciences has been awarded to a Japanese scientists and two American scientists for their discovery and research on T regulatory cells (TRegs).
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Less Education Yields Higher Cardiovascular Risk
Similar to the findings in rheumatoid arthritis, lower levels of education can have predictable negative consequences. And the reasons for more heart attacks with lower educational levels is not entirely clear.
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The RheumNow Week in Review – 6 January 2017
Dr. Jack Cush reviews highlights from the first week of 2017 on RheumNow.com.
Happy New Year!
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PPI Safety Issues
There are more than 11 million proton pump inhibitor (PPI) prescriptions written each year in the United States. While these agents have dramatically changed the management and outcome of upper gastrointestinal (GI) erosive and inflammatory disorders, their use has not been without safety concerns.
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A Low Risk of Inflammatory Bowel Disease with IL-17 Inhibition
Colitis onset or worsening inflammatory bowel disease has been reported with either of the new IL-17 inhibitors, ixekizumab (IXE) and secukinumab (SEC). Large database studies show these to be rare.
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CHMP Recommend Baricitinib for Approval in Europe
Eli Lilly and Company announced last friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of baricitinib for the treatment of adults with moderate to severely active rheumatoid arthritis (R
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A Link Between Periodontal Disease and Rheumatoid Arthritis
Research from Johns Hopkins reports that rheumatoid arthritis (RA) patients with periodontitis exhibited patterns of autoantigen hypercitrullination similar to that seen in RA. Results published in Science Translational Medicine showed that Aggregatibacter actinomycetemcomitans can produce hypercitrullination of patient neutrophils, indicating its possible role in triggering RA. (Citation source: http://buff.ly/2hZTBG8)
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Risk of GI Perforations on Biologics
Gastrointestinal perforation is a rare but serious complication that RA patients may be at particular risk for.
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RheumNow Week in Review – 16 December 2016
Dr. Jack Cush reviews highlights from this week on RheumNow.com
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EULAR 2016 Recommendations on Early Arthritis
Combe and leading European rheumatologist have published an update to the 2007 European League Against Rheumatism (EULAR) recommendations for management of early arthritis.
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Rituximab May Reduce Mortality Risk in Rheumatoid Lung Disease
While it is known that rheumatoid arthritis (RA) patients with interstitial lung involvement is associated with severe seropositive disease and is associated with an increased mortality.
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Nonsignificant CV Risk with Actemra vs Enbrel
WASHINGTON -- Rheumatoid arthritis is a recognized risk factor for heart attacks and stroke, but a study comparing two leading biologics found only a non-significant increase in relative risk for patients treated with toclizimab (Actemra) vs etanercept (Enbrel), researchers reported here.
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Key Lessons from the TNF Inhibitor Head-to-Head EXXELERATE Study
The EXXELERATE study is featured prominently in Lancet this week. In some ways, this represents a landmark negative trial that rheumatologists should review and be aware of.
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Is ABT-494 the Next JAK Inhibitor?
Tofacitinib may well be joined by a new once daily JAK inhibitor, baricitinib in the next few months.
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The RheumNow Week in Review – 2 December 2016
Dr. Cush highlights reports from this week on RheumNow.com.
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