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Dr. Woodcock Gives Senate FDA Update on Biosimilars
Biologics have been a great advance in therapeutics, but at great cost. Although biologics account for less than 1% of all prescriptions in the USA, they account for 28% percent of the cost of prescribed medications.
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Biosimilar SB4 Performs Equally to Etanercept
Biosimilars are rapidly growing. Many of these will have their first introduction to countries outside of the USA. There is concern whether biosimilars will provide identical pharmacodynamics, biological function, efficacy and toxicity to reference products, both in the short and long term.
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PLLR - The Pregnancy & Lactation Labeling Rule Explained
A recent article from Healio.com reviewed the FDA’s Pregnancy and Lactation Labeling Rule (PLLR) that became effective June 30th.
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Future 2 Trial Shows Secukinumab Efficacy in Psoriatic Arthritis
Secukinumab (Cosentyx) is an anti-IL-17 monoclonal antibody currently approved for use in moderate to severe psoriasis. It has also been studied in psoriatic arthritis (PsA) and shown to be safe and effective.
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DAS28-CRP or DAS28-ESR: Are they Biosimilar?
The disease activity score (DAS28) has been developed as a dynamic assessment tool and a therapeutic response measure for use in clinical trials and practice.
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New Drugs, New Hope for Pulmonary Fibrosis
The Wall Street Journal reports that new drug development offers hope for people with idiopathic pulmonary fibrosis, a rare, progressive fibrosing lung disorder that affects nearly 200,000 Americans, mostly middle-aged and older adults.
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Gouty Tomatoes, Alveolar Hemorrhage and Famous RA Faces: August 2015 Top Social Media News
In August, RheumNow published 76 tweets covering novel news, research and teaching points gleaned from the medical literature, regulatory reports and internet sources. We had a reach (impressions) of 60,800, with 45 mentions, and 2049 visits to RheumNow.com.
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A Controlled Trial of Yoga Benefits Arthritis Patients
Yoga and stretching appear to be important forms of exercise for patients with fibromyalgia, but their utility has seldom been explored in patients with rheumatoid or osteoarthritis.
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Can Fibromyalgia in Children be Treated Without Medication?
The hallmarks of fibromyalgia -- widespread pain, poor sleep, effort intolerance, fatigue -- are difficult to manage and usually require medication and a multi-modal approach.
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Monitoring of Novel Therapies in Rheumatology
The rheumatology therapeutic landscape has changed almost yearly in the last 15 years, with the introduction of at least 16 biologic or novel agents for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), spondyloarthritis (SpA), juvenile arthritis,
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Adalimumab FDA Approved for Hidradenitis Suppurativa
Abbvie announced on 9/10/15 that adalimumab (Humira) has been FDA approved for the treatment of moderate to severe hidradenitis suppurativa (HS) and is now the first and only FDA-approved therapy for adults with HS.
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JIA Pathogenesis Related to Neutrophils and Epigenetics
Neutrophils are pivotal players in the innate immune response, but are seldom linked to the pathogenesis of inflammatory arthritis, including juvenile idiopathic inflammatory arthritis (JIA).
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Education of the Fibromyalgia Patient
This week's Daily Download is the fibromyalgia “packet” we give to our patients once they have been diagnosed with fibromyalgia.
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Drug Safety Reports & FDA Updates – August 2015
Safety reports from literature include long-term safety of rituximab, rituximab-induced neutropenia, tabalumab (Anti-BAFF Mab) results from the ILLUMINATE trial, colchicine toxicity increased in CKD patients, FDA updates and drug labeling changes, and more.
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Serious Infections Increased in Etanercept-Treated Juvenile Arthritis Patients
UK researchers set out to study medically significant infections (MSI) in juvenile idiopathic arthritis patients enrolled in the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study (BSPAR-ETN).
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More Knee Replacements at Younger Ages
The National Hospital Discharge Survey shows that between 2000 and 2010, more than 5.2 million total knee replacements were performed in the United States. By 2010, the operation had become the leading inpatient surgery performed on adults aged 45 and over.
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SCOT Study Shows NSAID Safety
Since the 2005 FDA hearing that resulted in the removal of Vioxx and Bextra from the US market, the safety of nonselective NSAIDs (nsNSAIDs) and selective Cox-2 inhibitors (e.g., celecoxib) has been repeatedly questioned, often without new or substantive data.
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Hospitalized Infections are Higher with the Second Biologic
Using Medicare claims data on 189,326 RA patients, researchers at the University of Alabama at Birmingham examined the rates of hospitalized infections in previously biologic-treated RA patients and compared rates in cohorts starting new treatment with etanercept, adalimumab, certolizum
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Romosozumab Surpasses Teraparitide in the STRUCTURE Study
The experimental bone drug, romosozumab, has succeeded in meeting its primary endpoint by showing it was significantly more effective than teriparatide in a 12-month study assessing total hip bone density in postmenopausal women with osteoporosis.
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Advances in Uveitis Associated with Juvenile Arthritis
Uveitis is a common association of juvenile idiopathic arthritis (JIA) that has previously been characterized by poor visual prognosis with limited options for effective treatment.
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