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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
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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.
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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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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
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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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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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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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