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Therapeutic Update: 5 Questions on Sirukumab FDA Hearing
Drs. Cush and Gibofsky answer 5 questions about the August 2, 2017 FDA Arthritis Advisory Committee meeting that reviewed the NDA for sirukumab use in rheumatoid arthritis. The panel voted against (1-12) the approval of sirukumab.
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MSK Ultrasound Now Standard for Rheumatology Training
In the United States, musculoskeletal ultrasound (MSUS) in rheumatology has grown significantly in the last few decades. Ten years ago, more than half of rheumatology fellows had training or exposure to MSUS. A current survey of training programs shows that 94% provide MSUS training.
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H1N1 Vaccination Triggers TLR Activation and Autoantibody Production in DMARD-naïve pSS
Increased morbidity and mortality from infectious causes in patients with autoimmune disorders has led to the overall consensus that vaccination of such patients is important and should be widely promoted in clinical practice.
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FDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis
On Thursday, August 3, the FDA Arthritis Advisory Committee (AAC) met to consider tofacitinib for use in patients with psoriatic arthritis. The panel voted 10-1 in favor of approval.
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The RheumNow Week in Review – 4 August 2017
Dr. Jack Cush reviews new FDA decisions on sirukumab and tofacitinib as well as other news items from the past week on RheumNow.com.
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Arthritis Advisory Panel Votes Down Sirukumab
On Wednesday, August 2, the FDA convened the Arthritis Advisory Committee (AAC) to evaluate the safety and efficacy of Janssen’s anti-IL-6 monoclonal antibody, sirukumab.
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Lupus Hospitalizations are Common
Patients with systemic lupus erythematosus (SLE) incur substantial morbidity and complications that may lead to hospitalizations and increased cost of lupus care. Researchers from the University Health Network in Toronto have published a review of SLE hospitalizations showing thta while comm
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One-Third of Americans Took Opioids in 2015
In the wake of the well-publicized "opioid epidemic", researchers report in the Annals of Internal Medicine (online July 31) that more than one third of U.S.
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CDC: Outbreak of Arthrocentesis Related Septic Arthritis Cases in New Jersey
In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an single outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products. The intraarticular injections were done using fluoroscopic visualization. The CDC has reported the results of its investigation.
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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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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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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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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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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.
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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