The FDA has notified healthcare professionals of a safety alert concerning tofacitinib (Xeljanz), noting that preliminary results from a long-term safety clinical trial show an increased risk of serious heart-related problems and cancer with tofacitinib (compared to adalimumab) when given to
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For a variety of reasons, the use of anti-malarials (chloroquine and hydroxychloroquine) rose dramatically in the pandemic; notable was the lack of proven benefit and the dramatic risk in reported adverse drug reactions (ADRs) associated with these drugs being used to treat SARS-CoV-2.
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.
A longitudinal observational cohort study of psoriatic arthritis (PsA) patients treated with biologic therapy finds relatively low persistence of selected biologic therapy in PsA patients
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.
Analysis of the NHANES (National Health and Nutrition Examination Survey) data suggests that one-third of the risk of developing rheumatoid arthritis (RA) in the USA is attributable smoking, obesity and alcohol intake.
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.
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.
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.
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?
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.
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.
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.
NEJM has published the interim analysis of the REGN-COV2 trial, wherein an antibody cocktail reduced viral loads with less clinical consequences.
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.
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
A Medicare claims analysis of rheumatoid arthritis (RA) patients showed that RA-associated interstitial lung disease (RA-ILD) was seen in nearly 5% of patients and was found to increase mortality risks, including respiratory and cancer mortality not explained by other factors.
The benefits of hydroxychloroquine in lupus are many, but if you were to withdraw HCQ? A recent study of five Canadian cohorts, suggests that certain baseline variables, including age, race, and steroid use, were predictive of flare in patients with SLE who tapered or discontinued treatment with hydroxychloroquine.
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