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Cardiac and Cancer Signals Tofacitinib Safety Alert from FDA

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

Adverse Events with Anti-malarials during the COVID Pandemic

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.

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.

Low Persistence of Biologics in Psoriatic Arthritis

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

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.

One-Third Rheumatoid Risk from Lifestyle

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.

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.

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.

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.

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.

JAK Inhibitor Misses Endpoint in Safety Study. Now What?

MedPage Today

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.

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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