New Zoster Vaccine Recommended by FDA Panel

Save

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.

New Recommendations on Biosimilar Use

Save

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.  

Increasing Deaths and Breaking Bad with Fentanyl

Save

Opioid overdose deaths quadrupled from 1999 to 2015 and accounted for 63% of drug overdose deaths in the United States in 2015. During 2010–2015, heroin overdose deaths quadrupled from 3,036 to 12,989, with heroin and illicitly manufactured fentanyl (IMF) as likely contributors to this trend.

DSB Reports & Updates – August 2017

Save

This Drug Safety Bulletin address FDA delay of baricitinib, etanercept effective at room temperature, Consumer Reports features on drug safety, no association between Alzheimer's and PPIs, AHRQ review of opioid drug safety, FDA safety abeling changes, drug shortages and more. 

Canakinumab Patients have Lower Risk of Lung Cancer

Save

The CANTOS trial has shown that interleukin 1β inhibition by Canakinumab (CAN) resulted not only in a reduction of cardiovascular deaths but also significantly decreased the incidence and death from lung cancer.

Turnabout for Baricitinib

Save

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. 

Shingles Vaccine Studies in A&R

Save

The current issue of Arthritis & Rheumatology features an editorial and two novel articles on the herpes zoster vaccine.

Canakinumab Reduces CV Outcomes in High Risk Patients

Save

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.

Another Adalimumab Biosimilar Approved

Save

On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).

Adalimumab Biosimilars Adding Up

Save

Reuters reports that yet another adalimumab biosimilar has been approved by European Union regulators.

The new drug is named Imraldi, and is manufactured by Samsung Bioepis, a company who has several biosimilars approved or in development for worldwide use.

It's Rheumatoid Arthritis, not the TNF inhibitor, that Drives Lymphoma Risk

Save

Evidence from multiple studies suggests there is an increased risk of lymphoma in rheumatoid arthritis (RA) that is believed to be linked to the cumulative activity of the disease.  

Therapeutic Update: 5 Questions on FDA Hearing for Tofacitinib in PsA

Save

In this Therapeutic Update, Drs. Mease, Gibofsky and Cush answer five questions regarding the August 3rd FDA Arthritis Advisory Committee meeting that reviewed the potential approval of tofacitinib (Xeljanz) in patients with active psoriatic arthritis. The panel was nearly unanimous (10-1) in favor of the efficacy and safety profile of of tofacitinib, and similarly voted 10-1 to approve this drug for use in PsA. Final decisions on these recommendations from the AAC panel will be made at a later date by the FDA. 

Pegloticase Infusion Reactions Largely Seen in Non-Responders

Save

The introduction of intravenous pegloticase (PEG) in 2010 was felt by many to be a major advance in the treatment of patients with severe, refractory tophaceous gout.  But for some, concerns over infusion reactions and safety have limited its use.

No Evidence to Support Use of Gabapentinoids in Low Back Pain

Save

Management of chronic low back pain (CLBP) is often complex, requiring multiple modalities and meds to control pain. An analysis of studies shows that Gabapentinoids, including pregabalin and gabapentin, have little to no benefits but significant risk of adverse effects.

Marijuana Has Little Effect on Most Types of Pain

Save

Cannabis has become a regulated product, and many states have made it available with the intent of treating a variety of medical disorders, including chronic pain. A metanalysis published in Annals of Internal Medicine has shown that while cannabis may help neuropathic pain, it is not proven to benefit other types of chronic pain.

The RheumNow Week in Review – 11 August 2017

Save

The RheumNow Week in Review caps the week's news every Friday. Dr Jack Cush reviews the news, journal reports and important events from the past week in rheumatology.

Therapeutic Update: 5 Questions on Sirukumab FDA Hearing

Save

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.

FDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis

Save

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.

The RheumNow Week in Review – 4 August 2017

Save

Dr. Jack Cush reviews new FDA decisions on sirukumab and tofacitinib as well as other news items from the past week on RheumNow.com. 

Arthritis Advisory Panel Votes Down Sirukumab

Save

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.