FDA Outlines its Guidance for Biosimilars

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The FDA has released its guidance document on biosimilar development, stating that this represents its current thinking and may not be the final document. The document was published last week and will be instrumental in the development of biosimilar products in this country. In the

Time for a New War on Drugs (Their Prices, That Is)

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Adjuvant Herpes Zoster Subunit Vaccine is 97% Effective in Adults

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Drug-Induced Lupus is Rare with TNF inhibitor Therapy

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Real World Biologic Success in Systemic JIA

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A retrospective review of 77 SoJIA patients revealed that 50-70% achieved inactive disease or remission when treated with IL-1 inhibitors (anakinra, canakinumab). Good responses were seen with tocilizumab or abatacept, but only 8% responded to etanercept.

Medicare Spends $2.5 billion on Prescription Nexium in 2013

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Medicare released its list of the most costly medicines presribed in 2013.

May is Lyme Disease Awareness Month

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Lyme disease is a multisystem disease caused by the spirochete Borrelia burgdorferi. The organism is transmitted through the bite of certain species of blacklegged ticks (Ixodes spp.).

DRESS Trial Shows TNFi Dose Reduction is Possible - Without Major Flares

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Can TNF inhibitor therapy be withdrawn in RA patients who are in remission?  The DRESS trial reports the results of randomized trial of 180 RA patients taking either etanercept or adalimumab. Patients were randomly assigned to either usual care (no dose reduction) or a stepwise increase

May is Arthritis Awareness Month

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May is Arthritis Awareness Month. Arthritis affects an estimated 52.5 million U.S. adults, is a common comorbidity among those with multiple chronic conditions, and is a leading cause of disability in the United States.

Diet, Exercise and Glucosamine Fail to Prevent OA in Overweight Females

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An at-risk population of 407 middle-aged overweight women (BMI ≥ 27 kg/m2) without clinical signs of knee osteoarthritis were prospectively studied for 2.5 years and randomized to receive either glucosamine or diet and exercise in a double-blind, placebo-controlled trial.

Calprotectin as a Biomarker in RA

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Calprotectin a major S100 protein, produced by leukocytes is a potential new biomarker for use as it may be more sensitive disease activity changes than conventional acute-phase proteins.

Chronobiology: When Will It's Time Come?

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Morning stiffness is a historic feature of RA and may be related to prolonged inactivity or the chronobiology of rheumatoid inflammation. Chronobiology and chronopharmacology are receiving consideration in investigation and RA trial design. Researchers from Maynooth, Berlin, Vienna and

Daily Aspirin Taken by More Than Half of Older U.S. Adults

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Despite guidelines stating that low dose aspirin is indicated for secondary prevention of MI and stroke, a recent survey shows that over half of US adults take daily low dose aspirin.

Review of Bisphosphonates and Atypical femoral fractures

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The Journal For Nurse Practitioners provides a succinct overview of atypical femoral fractures and bisphosphonates.   These popular agents account for 14 million prescriptions annually in the United States.

Lyme disease: recent advances and perspectives

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Lyme disease remains endemic in many parts of North America and continues as a public health concern. This article reviews endemic and nonedemic areas, the lack of an available Lyme vaccine, immune pathways and what is known about the vector and bug.

HLA-DRB1 Alleles Augment RA Severity and TNF Inhibitor Responses

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The HLA-DRB1 haplotype is a known risk factor for RA.

Preventing Hep B Reactivation Due to Immunosuppressive Drug Treatments

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Reactivation of hepatitis B virus infection can have devastating consequences, especially amongst those patients receiving immunosuppressive therapy.

Preventing Hepatitis B Reactivation Due to Immunosuppressive Drug Treatments

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Reactivation of hepatitis B virus infection can have devastating consequences, especially amongst those patients receiving immunosuppressive therapy.

A different point of view on RA

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Professor Fergus Shanahan, a consultant gastroenterologist and professor of medicine at University College Cork, has an issue with the label “auto-immune” disease being applied to conditions such as RA, lupus, multiple sclerosis, Crohn’s disease, asthma and type 1 diabetes.

FDA Enforces New Drug Safety Labeling for Pregnant Women

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The traditional FDA pregnancy risk categories (A, B, C, D, X) have been scrapped in favor of a new labeling mandate called the pregnancy and lactation labeling rule (PLLR). This change has been under consideration at the FDA for nearly 2 years and was brought about by the belief that the old