Drug Safety

Remdesivir FDA Approved for Hospitalized COVID-19

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The FDA has approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

FDA approved its 1st drug to treat COVID-19 -

Clinical Trial Boom or Bust in Severe COVID-19

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A number of recently published clinical trials are further defining the efficacy and outcomes of tocilizumab or remdesivir in treating SARs-CoV-2 infection.

Remdesivir

TNF Inhibitors or non-TNF Biologics - First Best Choice?

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Prospective observational findings from the CORRONA registry of rheumatoid arthritis (RA) patients compared clinical outcomes between initial aggressive therapy using either a tumour necrosis factor inhibitor (TNFi) or a non-TNFi (biological disease-modifying antirheumatic drugs (bDMARDs) and

FDA Warning on NSAIDs in Pregnancy

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The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications around 20 weeks or later in their

RheumNow Podcast – Good Time Charlie…. (10.16.20)

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Dr. Jack Cush sings the news and journal reports from the past week on RheumNow.com.

Abatacept vs. Upadacitinib in Biologic Refractory Rheumatoid Arthritis

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NEJM reports the results of the SELECT-Choice trial, a head to head study of upadacitinib (UPA) and abatacept (ABA) in biologic refractory rheumatoid arthritis (RA); 12 weeks results showed UPA was significantly more clinically effective than ABA using a DAS28-CRP remission, but ABA had fewer

ICI Arthritis Tied to Cancer Progression

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Cancer patients treated with immune checkpoint inhibitors (ICI) who develop severe arthritis may be at risk for progression of the malignancy, a single-center study suggested.

Almost 90% of patients treated with ICI develop immune-related adverse events, which can include pulmonary,

Tofacitinib and Thromboembolic Risk

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Mease and colleagues have reviewed the tofacitinib drug development and clinical trial data, finding the risk of venous (VTE) and arterial thromboembolism (ATE) to be low and augmented in patients with baseline cardiovascular abd VTE risk factors and those taking higher doses of tofacitinib (

Thrombotic Risk in Rheumatoid Arthritis Linked to Disease Activity

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A large RA cohort study from the Swedish Rheumatology Quality Register shows a higher risk of venous thromboembolism (VTE) in rheumatoid arthritis (RA)  and that risk is linked to RA disease activity. 

Hydroxychloroquine Shows No Benefit in Hospitalized COVID-19 Patients

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The NEJM reports on a controlled clinical trial showing patients hospitalized with Covid-19 given hydroxychloroquine (HCQ) do not have a lower incidence of death compared to those receiving routine care.

A total of 4716 patients who were hospitalized with Covid-19 were randomly to

RheumNow Podcast – Bad Disease & Bad Outcomes (10.9.20)

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Dr. Jack Cush Reviews the news and journal articles from the past week on RheumNow.com.

Biologics Beneficial in Eosinophilic Vasculitis

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Two biologic therapies showed promise in the treatment of refractory or relapsing eosinophilic granulomatosis with polyangiitis (EGPA) in a retrospective European study.

Among 63 patients who were treated with rituximab (Rituxan), remission or partial responses at 1 year were observed

Sustained Remission Off Therapy Unlikely in GPA

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A French Vasculitis Study Group analysis of their granulomatosis with polyangiitis (GPA) reveals that after 10 years, only 7% of GPA patients achieved sustained remission off therapy (SROT) and have never relapsed.

IL-1 Inhibition Alters Arthroplasty Rates

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A subanalysis of the CANTOS trial suggests that inhibition of interleukin-1β (IL-1β) can reduce rates of incident hip or knee replacement (THR/TKR) surgeries.

Fractures from Delays in Denosumab Reinfusions

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Denosumab is effective in osteoporosis when used on schedue, but research suggests that discontinuation leads to rapid reversal of effect; a new observational study has shown that delays in denosumab administration of more than 16 weeks results in an increased vertebral fracture risk,

Systemic Steroids Reduce Mortality in COVID-19

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JAMA Internal Medicine reports an analysis of COVID-19 clinical trials showing that critically ill patients with COVID-19 treated with systemic corticosteroids have an overall lower mortality rate.