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Sirukumab Turned Down by FDA
On Friday the U.S. Food and Drug Administration announced that will not approve Johnson & Johnson’s rheumatoid arthritis drug sirukumab, stating further data and study would be needed to establish its safety.
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22 September 2017 The RheumNow Week in Review
The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com. This week's report discusses survey results on membranous nephritis and patient perceptions of steroids, nonadherence, celebrity arthritis and IgG4 treatment.
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Rituximab Efficacy in IgG4 Related Disease
PLOS reports greater than 90% efficacy when rituximab (RTX) is used to treat patients with IgG4-related disease (IgG4-RD).
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15 September 2017 The RheumNow Week in Review
The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com. This week's report discusses metabolic syndrome in lupus, bisphosphonate holidays, vasculitis and vascular inflammation, vaccination, and the repeated wonders of Vitamin D.
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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.
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Jak 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.
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New 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.
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Do 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).
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1 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.
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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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