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DSB Reports and Updates - September 2016
Updates and journal articles on opioids, drug induced sarcoidosis, cancer and cancer recurrence risks with TNF inhibitors and biologics, and FDA labeling changes.
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Adalimumab Lowers Risk of Uveitis Flares in Visual I Study
Rheumatologists may encounter patients with intermediate, posterior and pan-uveitis as part of certain rheumatic diseases such as Behcet’s, but more frequently may be called on to co-manage these patients with steroid sparing agents.
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Shingles Plus Autoimmune Disease Hikes Stroke Risk
Patients with autoimmune inflammatory diseases who develop herpes zoster are at increased risk of stroke for the subsequent 3 months, with risks diminishing thereafter, analysis of Medicare data showed.
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AMA Policy on Freebies and Meals Clarified
A recent JAMA Internal Medicine report on pharmaceutical-sponsored meals disclosed that a $20 meal provided by a drug company could yields 2-5 times more prescriptions. (Citation source http://buff.ly/2cd58i0)
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Cost of Osteoporosis Care in the USA
The 2010 NHANES study suggests that the overall prevalence of osteoporosis (OP) in the USA is ~10% or 10.2 million older adults (> 50 yrs) had osteoporosis.
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Another Biosimilar Approval - Etanercep-szzs by Novartis
Yesterday the U.S. Food and Drug Administration approved a new biosimilar, Erelzi, (etanercept-szzs), for the same multipile indications as the originator Enbrel, including rheumatoid arthritis, plaque psoriasis, Erelzi, will be generically labelled as etanercept-szzs.
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FDA Approves Updated Denosumab Warnings
In 2015, the Food and Drug Administration (FDA) updated the warnings of all marked bisphosphonates to include the risk of osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFF).
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RheumNow Week in Review – 26 August 2016
Dr. Jack Cush reviews news and journal reports from the past week on RheumNow.com.
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Prior Cancer Patients May Safely Receive TNF Inhibitors or Rituximab
Current guidelines regarding the use of biologics in patients who have previously had a malignancy are based more on opinion than evidence.
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Remicade Patent Infringements Denied: Opens Door for New Biosimilars
A U.S. court has affirmed its decision that the patent for Johnson & Johnson's drug Remicade is invalid. This new ruling favors the intent of Celltrion and Pfizer, who are seeking to bring their biosimilar versions of infliximab to market in the near future.
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Consensus Recommendations for Juvenile Dermatomyositis
SHARE (Single Hub and Access point for pediatric Rheumatology in Europe) is a group established in 2012 to develop and optimize diagnostic and management regimens in Europe for children and young adults with rheumatic diseases.
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No Added Lymphoma Risk with TNF Inhibitor Use
Warnings of cancer, especially lymphoma, have accompanied the development and promotion of tumor necrosis factor inhbitors (TNFi) in the treatment of RA and other inflammatory disorders.
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EULAR: Guidance for Managing Lupus Pregnancy
The European League Against Rheumatism (EULAR) has published comprehensive recommendations on reproductive health and family planning for women with systemic lupus erythematosus and/or antiphospholipid syndrome – conditions that largely affect women of childbearing age.
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EULAR Updates Gout Guidelines
A EULAR task force of 24 individuals (including 15 rheumatologists) have updated their previous 2006 guidelines for gout. The current update, which includes 11 recommendations, is based on a systematic literature review and a Delphi consensus approach to recommendations.
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RheumNow Week in Review – 5 August 2016
Highlights from this week on RheumNow.com include:
1. Having #RA in addition to solid cancer (breast, lung, prostate, colon) increases mortality rates by 40-50% in elders https://t.co/aitjusmOai
2. The global market for rheumatoid arthritis therapies was $19.9 billion in 2015, expected to reach $21.3B by 2020 https://t.co/d2Sh5C8y9f
3. Half of doctors never heard of MACRA:Medicare Access & CHIP Reauthorization Act. Starts on Jan 1st! https://t.co/eYgWBWCw6y Blog:https://t.co/sRKZSOFyNV
And more!
Biosimilars are Bioequivalent to Original TNF Inhibitors
Chingcuanco and coinvestigators have reported on their comparative analysis of biosimilars and their originator TNF inhibitors in the current issue of Annals of Internal Medicine. (Citation source: http://buff.ly/2arTd1q)
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Long-Term Safety of Adalimumab Reviewed
Burmester and colleagues have published their review of the long-term outcomes and safety issues with the TNF inhibitor, adalimumab (ADA). The analysis included 15,132 patients exposed to adalimumab in global RA clinical trials.
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Will Patent Extensions Delay Biosimilar Arrivals?
In the last 6 months, the FDA Arthritis Advisory Committee has recommended three biosimilars (CT-P13, GP-2015, ABP-501) for approval, with one achieving FDA approval Inflectra/CT-P13) and the other two pending a probable approval in the months to come.
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ORBIT Study Shows Rituximab is Non-Inferior to TNF Inhibitors in Biologic Naive Patients
Porter and colleagues have reported that both rituximab (RTX) and tumour necrosis factor inhibitors (TNFi) are equally and highly effective in early, active, biologic-naive rheumatoid arthritis patients.
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RheumNow Week in Review – 15 July 2016
Dr. Jack Cush reviews highlights from this week's rheumatology news on RheumNow.com.
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