The RheumNow Week in Review – FDA Showdown for Baricitinib (4.27.18)

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Dr. Jack Cush reviews the news and FDA proceedings from the past week on RheumNow.com.

FDA Arthritis Panel Split on the Efficacy and Safety of Baricitinib in RA

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On Monday, April 23rd the FDA convened the Arthritis Advisory Committee (AAC) to evaluate Lilly’s resubmitted NDA for the approval of the JAK inhibitor baricitinib for use in rheumatoid arthritis (RA).

FDA Review: Take Two for Baricitinib

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FDA staff remain worried about the safety of baricitinib, an oral JAK inhibitor intended for treatment of rheumatoid arthritis, according to briefing documents prepared for an advisory committee meeting on Monday.

Will Aspirin Cotherapy Undermine Celecoxib’s Safety Effects?

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The PRECISION study took 11 years and 24,081 patients (90% OA; 10% RA).

The RheumNow Week in Review – Vitamin D Snark Report (4.20.18)

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Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com.  A second life for Syk kinase, Vitamin D talk, VTE, regulatory hearings and the Lupus clinic edge.

USPSTF Recommendations on Vitamin D, Calcium Supplementation to Prevent Fractures

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The U.S. Preventive Services Task Force (USPSTF) concludes current scientific evidence is insufficient regarding the use of vitamin D and calcium, alone or in combination, to prevent fractures in men and premenopausal women. The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium to prevent fractures in postmenopausal women. Current scientific evidence is insufficient regarding the use of vitamin D and calcium at doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium in postmenopausal women.

EMA to Review Methotrexate Overdose and Dosing Errors

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A recent meeting (April 9-12) of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) considered the problem of dosing errors with methotrexate (MTX), citing "continued reports of overdose." 

MMWR: Cannabis Use in the Colorado Workers

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MMWR reports that eight states, including Colorado, have legalized recreational marijuana for use by adults and that a study of use in Colorado has shown that nearly 15% of Colorado adult workers have used marijuana in the past 30 days.

Mayo and UAB Awarded $1 million Grant for Patient Research

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CreakyJoints and Pfizer have selected the Mayo Clinic and the University of Alabama at Birmingham (UAB) to each receive a $500K research award (funded by Pfizer Independent Grants) for Learning & Change.

"Breakthrough" Drug Designation by the FDA

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The current issue of the NEJM reviews the Food and Drug Administration (FDA) “breakthrough therapy” designation that was introduced in 2012 to expedite testing and approval of medications that were intended to treat serious or life-threatening conditions.  This status is granted when prelimi

Lancet Tackles the Global Challenge of Low Back Pain

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Lancet has several reports on low back pain (LBP) as a major problem worldwide, largely because of the aging population.

Low back pain is the leading cause of disability worldwide.

Cannabis Laws Lessen the Opioid Crisis

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Three reports from JAMA Internal Medicine demonstrate favorable trends with less opioid use when cannabis became legal.

Unmet Needs in Calcium Pyrophosphate Deposition Disease

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Abhishek et al have written on the results of an international survey of crystal arthritis experts and identified the unmet needs  regarding calcium pyrophosphate crystal deposition (CPPD) - research, classification, diagnosis and management.

Medicare Drug Prices Jump Ten Times the Inflation Rate

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CNN reports that a new congressional analysis of Medicare drug pricing shows the prices of the 20 most commonly prescribed brand-name drugs have risen nearly 10 times the annual rate of inflation in the past five years.

Anakinra May Attenuate Stroke Outcomes

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The journal Stroke has published a trial wherein the use of subcutaneous IL-1Ra (anakinra) was shown to reduce the peripheral inflammatory response in those with an acute ischemic stroke.

The RheumNow Week in Review - 23 March 2018

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Dr. Jack Cush reviews the highlights from the news, journals and major meetings. New announcements and approval from the FDA; novel associations between ANCA vasculitis and thyroid disease; flare rates after arthroplasty; and pregnancy outcomes for men and women.

mTOR Inhibition with Sirolimus Effective in Lupus

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Lancet reports that 12 months of sirolimus treatment is associated with improvement in lupus disease activity presumeably by correction of pro-inflammatory T-cell activity.

Novel Approach to Knee Osteoarthritis Pain

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Geniculate artery embolization was found to dampen knee pain arising from osteoarthritis, according to interim study results presented at the 2018 annual meeting of the Society of Interventional Radiology.

Time to Rethink Gout as a Chronic Disease

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The current issue of JAMA has a perspective article on Gout’s bad rap as dietary disease rather than the complex, chronic inflammatory disorder that is ineffectively treated in many.