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August 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths
On August 2, the US Food and Drug Administration (FDA) will convene a hearing of the Arthritis Advisory Committee (AAC) to review the safety of the novel IL-6 inhibitor, sirukumab, being developed by Janssen (Johnson & Johnson).
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NEJM: Actemra Effective in Giant Cell Arteritis
On May 22, Genentech received FDA approval for the use of subcutaneous (sc) tocilizumab (TCZ) in patients with giant cell arteritis (GCA) – also known as temporal arteritis.
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The RheumNow Week in Review – 28 July 2017
Dr. Jack Cush reviews the news and articles from the past week on RheumNow.com:
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Denosumab Increases Trabecular Bone
Bone mineral density (BMD) measurement vie DEXA scan commonly used to assess bone density and fracture risk in postmenopausal osteoporosis provides us with approximate assessment of bone health while lacking sensitivity in vertebral fracture risk prediction.
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Biosimilar Pricing Wars Have Begun
Despite the approval of four anti-TNF biosimilars in 12 months, their introduction into the U.S. market has been slow and - until now - with paultry discounts compared to their introduction throughout Europe, where discounts averaged 50% and were as high as 70% (compared to the price of Remicade).
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Increased Pulmonary Embolism Risk in Lupus Patients
Systemic lupus erythematosus (SLE) poses numerous vascular risks, many of which are thought to be autoantibody mediated.
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Tubulointerstitial Damage in Lupus Predicts ESRD Progression
The presence of tubulointerstitial damage (TID) may provide a potential window for early intervention in lupus nephritis (LN) to ward off end-stage renal disease (ESRD), according to a data analysis.
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Baricitinib Derailed by FDA Review
Eli Lilly and Co disclosed today that upon further discussions with the US Food and Drug Administration (FDA) there would be a delay in further regulatory decisions regarding baricitinib, a JAK inhibitor, that is being developed for use in rheumatoid arthritis (RA).
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Benlysta FDA Approved for Sub-Q Use in Lupus
The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for use in active, autoantibody‑positive Systemic Lupus Erythematosus (SLE) patients.
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Rheumatologists and Patients Concerns over Biosimilars - RheumNow “Live Vote” Results
The RheumNow “Live Vote” on the use, uptake and safety of biosimilars contrasts rheumatologist and patient views. Despite FDA approval and looming introduction, there is considerable concern, knowledge gaps and hesitancy regarding their uptake in the US. The survey's primary question demonstrates that less than one-third of US rheumatologists are prepared to adopt biosimilars when they are available.
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Inflammatory and Autoimmune Diseases are Not Rare in HIV Patients
HIV infection and AIDs has been associated with numerous complications, presumably resulting from impaired immunity from infection. Sporadic cases and small cohorts of patients with rheumatic and autoimmune syndromes have been described but epidemiology data on the prevalence is scarce.
Read ArticleThe RheumNow Week in Review – 21 July 2017
Dr. Jack Cush reviews the news from the past week on RheumNow.com:
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Adverse Maternal and Fetal Outcomes in Lupus - and Pre-Lupus Too
A population-based claim study from Sweden has shown that lupus and pre-lupus patients are at risk for adverse maternal and fetal outcomes.
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Obesity Impairs TNF Inhibitor Responses in Axial Spondyloarthritis
Investigators with the Swiss Clinical Quality Management (SCQM) program have studied the effects of obesity on patients with axial spondyloarthritis (axSpA) and, specifically, their response to tumor necrosis factor inhibitors (TNFi).
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CDC: Pneumococcal Vaccination in Adults
Streptococcus pneumonia is a leading cause of morbidity and mortality in adults; including patients with autoimmune diseases who are at particular risk.
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Acute Coronary Syndrome Increased in Early Rheumatoid Arthritis
It does not come as a surprise to anyone anymore that Acute Coronary Syndrome (ACS) is one of the major causes of morbidity and preterm mortality in RA. What we don’t know is what measures need to be taken to modify the risk and how effective such measures are.
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Cumulative Genetic Hit Hypothesis for Lupus
A recent report in Nature Communications has studied multiple nationalities has shown a "disentangled complex HLA multigenic effect" underlying the genetic basis of systemic lupus erythematosus (SLE).
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Curbside Consults - July 2017
Curbside Consults are cases submitted by our rheumatology colleagues as challenging therapeutic or safety issues. Answers are based on experience, with added evidence from the medical literature and published guidelines. Here are four new cases.
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Long-Term Additive Cardiovascular Benefit of Plaquenil and Aspirin in Lupus
Systemic lupus erythematosus (SLE) is associated with an increased risk of cardiovascular disease (CVD). The cardioprotective benefits of aspirin (ASA) are well known and the ancillary CV and diabetogenic effects of hydroxychloroquine (HCQ) have also been shown.
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FDA Approves Tremfya (guselkumab) for Plaque Psoriasis
The U.S. Food and Drug Administration (FDA) has approved the IL-23 inhibitor, Tremfya (guselkumab), for patients with moderate to severe plaque psoriasis.
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