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DSB Reports & Updates – July 2015
FDA Scours the Internet for Safety Signals. A Bloomberg News report shows how the FDA is using Google or Yahoo keyword searches to identify new safety signals or drug interactions, often more than a year before they were brought to light by the FDA based on prior methodologies de
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The Use of Non-TNF Biologic Treatments in Uveitis Reviewed
A systematic review of treatments used in autoimmune chronic uveitis after failure of DMARDs and at least one TNF inhibitor identified few patients (12 children and 34 adults), and few trials examining rituximab (3), abatacept (3), tocilizumab (3), and 1 each with alemtuzumab and anakin
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Guselkumab Tops Adalimumab in Psoriasis Trial
NEJM reports a 52 week, phase II trial in 293 adult patients with moderate-to-severe psoriasis (>10 BSA) who were randomized to receive either placebo, adalimumab or guselkumab - a novel IL-23 inhibitor.
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Neurologic Events with TNF Inhibitor Therapy
Demyelinating disorders are an uncommon complication of TNF inhibition and have been described with all TNF inhibitors but also with other biologics.
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Adalimumab Drug Levels Predict Efficacy
In a prospective study of 311 rheumatoid arthritis patients starting either adalimumab (ADA) or etanercept, investigators sought to correlate drug levels and/or anti-drug antibodies with clinical outcomes (citation source http://url.ie/z237).
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TNF inhibitors in Early Axial SpA Spares NSAID Use
In a 2 year follow-up of the DESIR cohort of patients with early inflammatory back pain (627 patients), TNF inhibitor use was associated with a significantly greater decrease in the median NSAID intake (from 54.9 to 1.9 in TNFi pts versus from 41.9 to 22.3 in non-TNFi pts, p0.05).
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Ustekinumab Efficacy in Psoriatic Arthritis: 2 Year SUMMIT Trial Results
615 adults with active PsA were randomized to ustekinumab (45mg group or 90mg group) or placebo with crossover at 24 weeks.
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Utility of Drug Levels and Anti-Drug Antibodies When Starting TNF inhibitors
A prospective cohort of 331 patients tested for anti-adalimumab (n=160) and anti-etanercept (n-171) antibodies after initiation of their TNF inhibitor therapy.
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Adherence to ETN/MTX is Greater Than Triple DMARD Therapy
Rheumatoid management hinges on choosing your best therapies first.
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Australia Allows Pharmacy Substitution with Biosimilars Without Notice
Biosimilars are copies of the biologic medicines used to treat inflammatory and immunologic conditions such as rheumatoid arthritis, multiple sclerosis and cancer- potentially at lower costs.
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NICE Judges Apremilast Less Cost Effective than TNF Inhibitors
The National Institute for Heath and Care Excellence has turned down Otezla for coverage under the U.K. healthcare system for psoriatic arthritis.
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Frequency of Infliximab Infusion Reactions
A Canadian registry shows that in community-based infusion clinics, infusion reactions to IFX are uncommon and mild to moderate in nature.
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DSB: EULAR 2015 Safety Reports
Biologic Use Curtails Sepsis Events. An analysis of the German biologics register, RABBIT, examined the effect of current biologic therapy on future risk of sepsis (#OP0161).
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The Risk of Uveitis in AS Treated with TNF Blockers
Claims data analysis of 2115 ankylosing spondylitis patients without uveitis who started TNF inhibitor therapy revealed that the median time to the onset of uveitis was longest for those taking adalimumab (243 days), followed by etanercept (182 days) and infliximab (144 days). 
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Expanding Global Biosimilar Market
Between 2010 and 2013, $95 billion in branded pharmaceutical patents will have expired, leading to significantly higher sales opportunities for those manufacturing generics and biosimilars.
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The EULAR 2015 Report- Friday
These abstracts and presentations were presented 12 June at the EULAR 2015 annual meeting.
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The EULAR 2015 Report - Wednesday
EULAR 2015 started the afternoon of Wednesday June 10th.
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Nonadherence to Self-Injected Biologics is High
Researchers from the University of Manchester investigated self-reported adherence to biologic treatment in RA and found that 41% of patients were non-adherent to adalimumab therapy at least once, and 23% were nonadherent overall. http://bit.ly/1KA2
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Amgen & Abbvie Increase the Price of TNF Inhibitors
The manufacturers of the 2 best selling TNF inhibitors, Enbrel and Humira, have announced a 9.9% price increase of May 1st. The current average price of Enbrel is $42,000 per annum.
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A Microneedle Pill as an Alternative to Injectable Drug
Carl Schoellhammerhas just won the Lemelson-MIT National Collegiate Student Prize for his invention - the microneedle pill.
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