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Health Canada Approves Subcutaneous Infliximab Biosimilar
The infliximab biosimilar CT-P13, developed by Celltrion and marketed as Remsima has been approved by HealthCanad for subcutaneous (SC) use in all the indications for infliximab.
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Vagal Nerve Stimulation in Rheumatoid Arthritis
Lancet Rheumatology has reported the results of a proof of concept trial, wherein vagal nerve stimulation was shown to ameliorate RA disease activity. The intervention involved non-invasive stimulation of the auricular branch of the vagus nerve using a wearable vagus nerve stimulation device for up to 30 min per day, delivering pulses of 20 kHz.
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RheumNow Podcast – Rheumatology Burnout (1.29.2021)
Dr. Jack Cush reviews this past week's journal articles and news features on RheumNow.com. Colchicine, vaccine rollout, risk of RA in endometriosis patients, tREACH trial, lupus nephritis news, rheumatology burnout and more.
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Calculating Serious Infection Risk in IMID Patients
Predictive modeling of data derived from the DANBIO registry (of treated IMID patients) revealed a 4 fold increased risk of serious infection (SIE) in those starting biologic DMARD (bDMARD) treatment. From this large dataset, researchers developed a simple prediction model to estimate future infection risk that may inform shared decision-making in individual patients.
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High Placebo Responses in SLE Trials
A systematic review by Urowitz and colleagues examined placebo responses in randomized controlled trials of non-renal, non-neuropsychiatric SLE patients showing unexpectedly high placebo responses; with more than one-third of the placebo-treated SLE patients responding by validated outcome measures.
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Lupus Nephritis Despite Low Level Proteinuria
Kidney International reports on a series of systemic lupus erythematosus (SLE) patients, who despite inactive urinary sediment and low level proteinuria, had a high rate of glomerulonephritis (GN) proven by renal biopsy; moreover, the LN was not predicted by laboratory abnormalities.
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JAK Inhibitor Misses Endpoint in Safety Study. Now What?
Pfizer announced results Wednesday from its FDA-mandated postmarketing safety study of tofacitinib (Xeljanz), and they don't bode well for the drug and possibly others in its class.
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Urate Lowering Therapy During Acute Gout
Acute gout has its well defined protocols, and most state that urate lowering therapy (ULT) should be continued; but does ULT affect outcomes in an acute gout attack?
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Rheumatologists Rank 2nd in Physician Burnout
The 2021 Medscape Survey on Physician burnout ranks rheumatology second, just behind Critical Care medicine.
The survey included over 12,000 physcians from 20 specialties. While 42% of MDs claimed to be burnt-out, Rheumatologists claimed this 50% of the time. The top 3 this year were Critical care (51%), Rheumatology (50%) and infectious disease (49%).
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Protective Effects of Colchicine in Non-Hospitalized COVID-19
A press release from Montreal Heart Institute announced that the COLCORONA clinical trial provided evidence of the protective effect of colchicine; demonstrating a 21% reduced risk of death or hospitalizations in patients with COVID-19 compared to placebo. COLCORONA trial was a contact-less, randomized, double-blind, placebo-controlled study of 4,488 non-hospitalized patients from Canada, the U.S., Europe, South America and South Africa.
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Voclosporin FDA Approved for Lupus Nephritis
On January 22nd, the FDA approved voclosporin (Lupkynis) for use in adults with active lupus nephritis; voclosporin is a calcineurin-inhibitor immunosuppressant indicated for use in combination with a background immunosuppressive therapy. FDA approval was based on data from the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study, which demonstrated the ability of voclosporin to significantly improve LN outcomes after 52 weeks of followup in SLE nephritis patients receiving background standard of care therapies like MMF, and low dose steroids.
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RheumNow Podcast – Don’t Hold the Benlysta, Take the Vaccine (1.22.2021)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com, with more than a dozen items to discuss on this week's podcast.
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NEJM: Early Combo Monoclonal Antibody Therapy in COVID-19
NEJM has published the interim analysis of the REGN-COV2 trial, wherein an antibody cocktail reduced viral loads with less clinical consequences.
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Combo Anti-Spike Protein Antibody for Mild to Moderate COVID-19
JAMA has published the BLAZE-1 study, showing significant SARS-CoV-2 viral load reduction at day 11 and less COVID-19 progression when combination anti-spike monoclonal antibody therapy (bamlanivimab and etesevimab) was given to mild to moderate, non-hospitalized COVID-19 patients.
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Low Risk of TB with Secukinumab
JAMA Dermatology has reported on a longitudinal cohort study of 12,319 secukinumab (SEC) treated patients (psoriasis, psoriatic arthritis, or ankylosing spondylitis); no new cases of active tuberculosis (TB) and very few cases of latent tuberculosis infection (LTBI) were f
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