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What Can 30 Years of Rheumatic Disease Research Tell Us About the Future?
As a practicing rheumatologist for more than 30 years, I can recall a time – just a couple of decades ago – when waiting rooms were full of patients in wheelchairs, debilitated and in pain from rheumatoid arthritis (RA) and other related conditions.
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Turnabout for Baricitinib
Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. Food and Drug Administration in late August 2017, Lilly will resubmit a revised New Drug Application for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data.
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Shingles Vaccine Studies in A&R
The current issue of Arthritis & Rheumatology features an editorial and two novel articles on the herpes zoster vaccine.
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Canakinumab Reduces CV Outcomes in High Risk Patients
The results of a randomized, double-blind trial have shown that canakinumab (CAN), an interleukin-1β inhibitor, given as 150 mg every 3 months, resulted in a significantly lower rate of recurrent cardiovascular events (in high-risk CV patients), independent of lipid-level lowering. The results of the CANTOS studywere simultaneously published in NEJM, Lancet and were presented at the European Society of Cardiology meeting in Barcelona.
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Another Adalimumab Biosimilar Approved
On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).
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The RheumNow Week in Review – 18 August 2017
The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com.
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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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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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No Increase in Malformations with Etanercept Use During Pregnancy
While there are several reports detailing uncontrolled, observational results of biologic use during pregnancy, most are hampered by low numbers, incomplete data and too small a sample to make reliable judgements regarding the teratogenicity. A company sponsored claims data analysis has shown that etanercept exposure during pregnancy was not associated with an increase in major congenital malformations (MCMs).
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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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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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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.
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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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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