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New Zoster Vaccine Recommended by FDA Panel
Reuters reports that the FDA advisory panel has voted 11-0 in favor of the safety and efficacy and ultimate approval of GlaxoSmithKline’s Shingrix shingles vaccine for use in adults aged 50 and over.
Read ArticleJak Inhibition May Ameliorate Pruritus
Interleukin-4 has been shown to activate sensory neurons involved in pruritus, and that inhibition of IL-4 with Jak inhibition significantly alleviates itching.
Read ArticleNew Recommendations on Biosimilar Use
The introduction of a growing number of biosimilars into the market poses a substantial change in cost of care for patients with inflammatory rheumatologic disorders.
Read ArticleDo Rheumatologists Use ACR/EULAR Guidance on Rheumatoid Arthritis? “Live Vote” Results
The June 2017 RheumNow “Live Vote” surveyed US and non-US rheumatologists and patients about how they diagnose and treat rheumatoid arthritis (RA) and whether they rely on newer diagnostic criteria and management guidelines propagated by the American College of Rheumatology (ACR).
Read Article1 September 2017: The RheumNow Week in Review
This week's report includes new data on IL-1 inhibition and protection from CV events and lung cancer, baricitinib given a reprieve, and features on infections: HBV, shingles and mortality of septic arthritis.
Read ArticleWhat 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.
Read ArticleTurnabout 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.
Read ArticleShingles Vaccine Studies in A&R
The current issue of Arthritis & Rheumatology features an editorial and two novel articles on the herpes zoster vaccine.
Read ArticleCanakinumab 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).
Read ArticleThe 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.
Read ArticleTherapeutic 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.
Read ArticleFDA 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.
Read ArticleThe 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.
Read ArticleArthritis 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.
Read ArticleNo 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).
Read ArticleAugust 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).
Read ArticleNEJM: 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.
Read ArticleDenosumab 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.
Read ArticleBiosimilar 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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