The RheumNow Week in Review - 6 October 2017

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The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com. In this week's report, Dr. Jack Cush discusses when to hold the biologic, lymphoma risk with tofacitinib, early clues to the diagnosis of RA, biologic use in pregnancy, what's killing psoriasis patients and the 2016 top 5, best selling drugs in rheumatology.

Amgen-Abbvie Settle Humira Biosimilar Patent Dispute

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Amgen's biosimilar version of adalimumab (Humira) was FDA-approved in September 2016 and given the trade name Amjevita (generic: adalimumab-atto). This new TNF inhibitor biosimilar has not yet been to market because of legal wranglings over patent issues by Abbvie's Humira.

29 September 2017 The RheumNow Week in Review

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The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com. This week's report discusses regulatory actions by NICE and FDA, higher death rates in RA and psoriasis, increased risk of RA with Asthma, rising numbers for OA, RA, and STDs.

No Cancer Risk With Biologic Use

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A polulation-based study from Sweden has shown that treatment with tocilizumab, abatacept, rituximab, or tumor necrosis factor (TNFi) inhibitors does not affect the risk of malignant neoplasms among patients with rheumatoid arthritis. Specifically, use of a first or second TNFi or biologic DMARDs (bDMARD) does confer a different cancer risk when compared to conventional DMARDS in biologic–naive RA patients.

FDA Panel Backs New Zoster Subunit Vaccine

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GlaxoSmithKline has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously in support of the efficacy, safety and approval of its herpes zoster subunit (HZ/su) vaccine (called Shingrix) for the prevention of herpes zoster (shingles) in adults ages 50 and over.

New Recommendations on Biosimilar Use

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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.  

Shingles Vaccine Studies in A&R

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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

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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

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

Adalimumab Biosimilars Adding Up

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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.

Non-Tuberculous Mycobacterial Infections - Diagnosis and Management for the Rheumatologist

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Non-Tuberculous Mycobacterial infections are among the most frequently reported opportunistic infections in the setting of biologic therapy. While there are hundreds of NTM species, only a minority are clinically relevant. In this review, I'll address important NTM diagnosis and management issues relevant to patients receiving biologic therapy.

IV Golimumab Shines in Psoriatic Arthritis

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Golimumab (GOL) is one of five marketed TNF inhibitors (TNFi) that is FDA approved for use in psoriatic arthritis (PsA).

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

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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.  

The RheumNow Week in Review – 18 August 2017

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The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com.

Uveitis Events Reduced with Select TNF Inhibitors

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Uveitis may occur in up to 40% of spondyloarthritis patients. Metanalyses have shown that treatment with tumour necrosis factor-α inhibitor may reduce the rates of anterior uveitis. A multicenter study from Sweden and Norway has confirmed that amongst TNFi, adalimumab and infliximab offer better protection against AU than etanercept.

Therapeutic Update: 5 Questions on Sirukumab FDA Hearing

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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

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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

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

No Increase in Malformations with Etanercept Use During Pregnancy

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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).

The RheumNow Week in Review – 28 July 2017

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Dr. Jack Cush reviews the news and articles from the past week on RheumNow.com: