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. 

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.

PLOS reports  greater than 90% efficacy when rituximab (RTX) is used to treat patients with IgG4-related disease (IgG4-RD). 

The NEJM reports that in high risk post-menopausal women, romosozumab for 12 months followed by alendronate resulted in a significantly lower fracture than alendronate alone. 

A French retrospective study of 318 Takayasu's arteritis (TA) patients shows that 50% of patients will relapse and experience a vascular complication ≤10 years from diagnosis. 

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.

Interleukin-4 has been shown to activate sensory neurons involved in pruritus, and that inhibition of IL-4 with Jak inhibition significantly alleviates itching.

Infections and noninfectious pulmonary disease were associated with an increased risk for idiopathic inflammatory myopathies (IIM), a Swedish study found.

 Adult-onset Still's disease (AOSD) is the adult continum of systemic-onset juvenile idiopathic arthritis (SoJIA). Treatment of this febrile polyarticular systemic disorder can be complex, but has been relieved by several specific biologic therapies.

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.  

A large multi-center study of cardiovascular (CV) risk factors in rheumatoid arthritis (RA) has shown, after nearly 6 years follow-up, more CV events in males than females (21% vs. 11%, respectively) and that RA itself accounts for 30% of the attributable CV risk.

Noe and colleagues have reported in the Journal of Investigative Dermatology that by estimating the extent of skin involvement in psoriasis (%BSA) they may assess future mortality risk. 

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.

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.

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. 

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.

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. 

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

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.

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.