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. 

Pediatric Consensus on Comorbidity Assessments

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Comorbidity is a serious consequence or confounder in patients with inflammatory diseases. This has been well described in both psoriatic and rheumatoid disease.

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).

Biosimilar Pricing Wars Have Begun

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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).

Rheumatologists and Patients Concerns over Biosimilars - RheumNow “Live Vote” Results

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The RheumNow “Live Vote” on the use, uptake and safety of biosimilars contrasts rheumatologist and patient views. Despite FDA approval and looming introduction, there is considerable concern, knowledge gaps and hesitancy regarding their uptake in the US. The survey's primary question demonstrates that less than one-third of US rheumatologists are prepared to adopt biosimilars when they are available.

Inflammatory and Autoimmune Diseases are Not Rare in HIV Patients

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HIV infection and AIDs has been associated with numerous complications, presumably resulting from impaired immunity from infection.  Sporadic cases and small cohorts of patients with rheumatic and autoimmune syndromes have been described but epidemiology data on the prevalence is scarce.

Obesity Impairs TNF Inhibitor Responses in Axial Spondyloarthritis

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Investigators with the Swiss Clinical Quality Management (SCQM) program have studied the effects of obesity on patients with axial spondyloarthritis (axSpA) and, specifically, their response to tumor necrosis factor inhibitors (TNFi).

FDA Approves Tremfya (guselkumab) for Plaque Psoriasis

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The U.S. Food and Drug Administration (FDA) has approved the IL-23 inhibitor, Tremfya (guselkumab), for patients with moderate to severe plaque psoriasis.

Statins Improve Survival in Ankylosing Spondylitis

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Systemic inflammation (from underling inflammatory polyarthritis) clearly accelerates atherosclerosis with a resultant increase risk of cardiovascular disease.

Orencia Approved for Use in Psoriatic Arthritis

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The FDA has approved both IV and SC ORENCIA (abatacept) for the treatment of adults with active Psoriatic Arthritis.

IV Golimumab in Psoriatic Arthritis

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Based on recent clinical trials, the makers of golimumab have petitioned the FDA for new indications in PsA and AS. Trials for PsA (GO-VIBRANT) and AS (GO-ALIVE) were presented at last weeks EULAR 2017 meeting in Madrid, Spain.

Tildrakizumab, an IL-23 Inhibitor, is Successful in Plaque Psoriasis

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Therapeutic options for cutaneous psoriasis (and psoriatic arthritis as well) are rapidly expanding.  Lancet has published the impressive results of two phase III trials of tildrakizumab, a IgG1 antibody against interleukin 23 p19, in patients with active chronic plaque psoriasis.

ACR/AAHKS Guidelines on Perioperative Management

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The American College of Rheumatology has partnered with the American Association of Hip and Knee Surgeons to develop consensus-based guidelines for perioperative management of antirheumatic therapies for patients with rheumatic diseases who plan to undergo total joint replacement.

EULAR 2017 – Day 4 Highlights

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Saturday was a day of big posters and special seminars at EULAR in Madrid.  In the morning, I passed on an interesting session on nailfold capillaroscopy led by Dr. M Cutolo and went to a JIA outcomes session.

EULAR 2017 – Day 3 Highlights

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Friday was a mega-day in Madrid as this day all the late-breaking abstracts were presented, in addition to the bulk of high-impact podium presentations in several areas.

Here are the major presentations from several clinical areas.

EULAR 2017 – Day 2 Highlights

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The heat was on at EULAR 2017 for busy presenters and attendees navigating the 104F degree temperatures at the indoor/outdoor IFEMA Convention center in Madrid.

Day 2 (Thursday) were big days for gout, drug safety, psoriatic arthritis and spondyloarthritis.