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FDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis
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.
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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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Romosuzumab Outperforms Teriparatide in Post-Bisphosphonate Osteoporosis
The STRUCTURE trial results have been reported in Lancet and have shown that after 12 months of therapy, romosozumab (ROMO) had superior gains in bone mineral density (BMD) compared to teriparatide (TER) in women with postmenopausal osteoporosis who have previously taken bisphosphonate therapy.
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Lupus Hospitalizations are Common
Patients with systemic lupus erythematosus (SLE) incur substantial morbidity and complications that may lead to hospitalizations and increased cost of lupus care. Researchers from the University Health Network in Toronto have published a review of SLE hospitalizations showing thta while comm
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One-Third of Americans Took Opioids in 2015
In the wake of the well-publicized "opioid epidemic", researchers report in the Annals of Internal Medicine (online July 31) that more than one third of U.S.
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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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NEJM: Actemra Effective in Giant Cell Arteritis
On May 22, Genentech received FDA approval for the use of subcutaneous (sc) tocilizumab (TCZ) in patients with giant cell arteritis (GCA) – also known as temporal arteritis.
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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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Denosumab Increases Trabecular Bone
Bone mineral density (BMD) measurement vie DEXA scan commonly used to assess bone density and fracture risk in postmenopausal osteoporosis provides us with approximate assessment of bone health while lacking sensitivity in vertebral fracture risk prediction.
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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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Increased Pulmonary Embolism Risk in Lupus Patients
Systemic lupus erythematosus (SLE) poses numerous vascular risks, many of which are thought to be autoantibody mediated.
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Tubulointerstitial Damage in Lupus Predicts ESRD Progression
The presence of tubulointerstitial damage (TID) may provide a potential window for early intervention in lupus nephritis (LN) to ward off end-stage renal disease (ESRD), according to a data analysis.
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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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Benlysta FDA Approved for Sub-Q Use in Lupus
The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for use in active, autoantibody‑positive Systemic Lupus Erythematosus (SLE) patients.
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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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