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FDA Public Review of CBD Oil
The US Food and Drug Administration convened a public hearing and specialty panel on May 31st to review the potential use, safety and effectiveness of cannabidiol (CBD) products that do not contain THC.
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Proinflammatory Diets May Increase CRP and RA Onset
Despite the lack of good evidence, there has been great speculation about the role of diet in causing or alleviating inflammation. Now there's new research suggesting that proinflammatory diets can increase serum C-reactive protein levels and also the risk of rheumatoid arthritis onset.
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Might IL-17 Inhibition Be Effective in RA?
Interleukin 17 (IL-17) inhibitors are highly effective and FDA approved for use in psoriasis, psoriatic arthritis and ankylosing spondylitis. However, many of the initial trials were done in rheumatoid arthritis (RA) where it was projected to be effective, but was not. A recent metanalysis examines how effective IL-17 inhibition was in two RA populations: biologic-naïve or tumor necrosis factor inhibitor inadequate responders (TNF-IR).
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Despite Gout Numbers and Flares, Allopurinol is Underutilized
A population-based survey from South Australia shows that gout flares are common in the community and have a significant effect on health-related quality of life (HRQoL), yet there is significant undertreatment of gout, even in those on current allopurinol.
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RheumNow Podcast – Rituximab Monitoring (5.31.19)
Dr. Jack Cush presents the news and best of rheumatology and medicine from the past week on RheumNow.com
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Lupus Disease Control with Rituximab
Rituximab (Rituxan) may be an option for maintenance therapy in patients with difficult-to-treat systemic lupus erythematosus (SLE), European researchers reported.
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Upadacitinib Monotherapy in MTX-IR Rheumatoid Arthritis
Upadacitinib (UPA) is an oral, selective JAK1-selective inhibitor being developed for use in rheumatoid arthritis patients; Lancet has reported the SELECT-MONOTHERAPY trial showing that UPA is safe and effective in RA patients with an inadequate response to methotrexate (MTX).
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Predictors of Serious Infections with Rituximab
The risk of serious infectious events (SIE) with rituximab (RTX) is similar to that seen in other biologics (e.g., RA: 2% or 4.3/100PY), but with prolonged use the risk may change. Recent research says that low IgG levels, RTX induced neutropenia, prior SIE and comorbidities can significantly augment this risk.
A retrospective longitudinal single center study of 700 rheumatic and musculoskeletal diseases (RMDs) treated monitored serum immunoglobulins (at baseline and 4–6 months after each cycle), clinical outcomes and SIE over time.
RheumNow Podcast – Medical Selfies (5.24.19)
Dr. Jack Cush Reviews the news and journal articles from the past week on RheumNow.com
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Nintedanib May Benefit Systemic Sclerosis Related Interstitial Lung Disease
The NEJM reports a randomized placebo controlled trial of nintedanib, a tyrosine kinase inhibitor, in systemic sclerosis patients with interstitial lung disease (ILD) resulted in less pulmonary decline, but had no effect on other features of systemic sclerosis.
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Steroids, Not Biologics, Drive Arthroplasty Infections in RA
Medicare and Truven MarketScan administrative data study (2006 through 2015) of rheumatoid arthritis (RA) undergoing arthroplasty found that while that the risks of perioperative infection was similar across biologics, the infection risk with glucocorticoid use, especially at
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EMA Restricts Tofacitinib Dosing
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued recommendations limiting the use of Xeljanz (tofacitinib) 10 mg twice daily in patients with ulcerative colitis in the EU.
The new recommendations are temporary while PRAC undertakes a review of all available evidence on the safety and efficacy of tofacitinib. The review follows warnings of an increased risk of pulmonary embolism (PE) and death from the U.S. Food and Drug Administration based on Pfizer's large post-marketing safety study (in high risk rheumatoid arthritis patients with one or more underlying cardiovascular risk factors) wherein those receiving in tofacitinib 10 mg twice daily in study A3921133 had more PE and mortalities than comparator groups (tofacitinib 5 mg bid or adalimumab).
Opioids, SSRIs and Steroids Increase Fracture Risk in RA
Analysis of a large US observational rheumatoid arthritis (RA) patients finds that opioids, SSRIs and glucocorticoids were associated with increased risk of fracture in RA, whereas statins and TNFi had a decreased vertebral fracture risk.
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RheumNow Podcast – Richer or Poorer (5.17.19)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com
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Coexistent Gout Increases Risk in Rheumatoid Arthritis
It his often said that gout and rheumatoid arthritis (RA) cannot coexist and where confusion exists, a good history and testing for serum urate (SUA) and rheumatoid factor (RF) can usually clarify the dominant disorders. A recent study shows that hyperuricemia and gout are uncommon in RA, but when present shows an increased risk of comorbidities and cardiovascular (CV) mortality.
Risk Score Predicts Thrombosis Recurrence in APS
A combination risk score helped predict recurrent thrombosis -- particularly arterial -- among patients with antiphospholipid syndrome (APS), an international study found.
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FDA Final Guidance on Interchangeability with Biosimilars
The FDA has published an industry guidance document to define interchangeability as regards to biosimilar use in the United States under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).
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Less Structural Damage with T2T in Gout
A two‐year randomized clinical trial has demonstrated that allopurinol dose escalation to a target serum urate (SU) results in less bone erosion, structural damage and urate crystal deposition in patients with gout.
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Methotrexate Use Not Linked to Interstitial Lung Disease in RA
People with rheumatoid arthritis have a significant risk of developing interstitial lung disease (RA-ILD), yet there is often a question as to whether methotrexate (MTX) exposure can cause or worsen ILD. A controlled cohort study suggests that MTX use is not associated with an increased ris
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Generic Price Fixing Alleged by State Prosecutors
The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars.
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