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JIA Worsens Quality of Life Long into Adulthood
Adult patients with a history of juvenile idiopathic arthritis (JIA) showed poorer health-related quality of life decades later, compared with individuals who were healthy as children -- even if they were in clinical remission, reported researchers in Norway.
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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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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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Pediatric Consensus on Comorbidity Assessments
Comorbidity is a serious consequence or confounder in patients with inflammatory diseases. This has been well described in both psoriatic and rheumatoid disease.
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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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CDC: Outbreak of Arthrocentesis Related Septic Arthritis Cases in New Jersey
In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an single outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products. The intraarticular injections were done using fluoroscopic visualization. The CDC has reported the results of its investigation.
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August 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths
On August 2, the US Food and Drug Administration (FDA) will convene a hearing of the Arthritis Advisory Committee (AAC) to review the safety of the novel IL-6 inhibitor, sirukumab, being developed by Janssen (Johnson & Johnson).
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The RheumNow Week in Review – 28 July 2017
Dr. Jack Cush reviews the news and articles from the past week on RheumNow.com:
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Biosimilar Pricing Wars Have Begun
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).
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Baricitinib Derailed by FDA Review
Eli Lilly and Co disclosed today that upon further discussions with the US Food and Drug Administration (FDA) there would be a delay in further regulatory decisions regarding baricitinib, a JAK inhibitor, that is being developed for use in rheumatoid arthritis (RA).
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Rheumatologists and Patients Concerns over Biosimilars - RheumNow “Live Vote” Results
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.
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Inflammatory and Autoimmune Diseases are Not Rare in HIV Patients
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.
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Acute Coronary Syndrome Increased in Early Rheumatoid Arthritis
It does not come as a surprise to anyone anymore that Acute Coronary Syndrome (ACS) is one of the major causes of morbidity and preterm mortality in RA. What we don’t know is what measures need to be taken to modify the risk and how effective such measures are.
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Curbside Consults - July 2017
Curbside Consults are cases submitted by our rheumatology colleagues as challenging therapeutic or safety issues. Answers are based on experience, with added evidence from the medical literature and published guidelines. Here are four new cases.
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The RheumNow Week in Review – 14 July 2017
Dr. Jack Cush reviews highlights from the past week on RheumNow.com:
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Withdrawal of TNF Inibitors Fails in Most RA Patients
The 12 month POET study analyzed 817 rheumatoid arthritis (RA) patients who achieved remission or low disease activity (LDAS) for ≥6 months and then randomized 2:1 to stopping or continuing their TNF inhibitor.
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Alendronate Use in Steroid Treated Patients Lowers the Risk of Hip Fracture
Among older patients using medium to high doses of the anti-inflammatory steroid prednisolone, treatment with the osteoporosis drug alendronate was associated with a significantly lower risk of hip fracture, according to a study published by JAMA.
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Linkage Between Gut and Joint Immunity in Rheumatoid Arthritis
Pianta, et al have published their findings in the Journal of Clinical Investigation showing that two novel autoantigens, GNS and FLNA, are highly expressed in synovium and share a sequence homology with gut microbesa; thereby providing a potential link between gut mucosal and joint immunity in rheumatoid arthritis.
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ACR/AAHKS Guidelines on Perioperative Management
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.
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