Results of trial A 392113 of Xeljanz XR raises safety concerns with 10 mg twice daily dose. Pfizer
When Xeljanz XR (tofacitinib extended release) from Pfizer, was approved in 2016 the approval carried warnings of risk of serious infection and advice to monitor lipid levels as the drug was associated with an increase in cholesterol.The FDA required Pfizer to undertake a new cardiovascular risk trial before approval of a 10mg twice daily dose.
The trial A392113 involved patients aged 50 or older with at last one cardiovacsular risk factor.The Rheumatology Drug Safety Monitoring Board noted that patients treated with tofacitinib extended release 10 mg twice daily had a statistically and clinically important difference in occurrence of pulmonary embolism compared with patients in the study treated with a TNF inhibitor and noted an increase in overall mortality in the 10mg twice daily group compared to the tofacitinib 5 mg twice daily and TNF inhibitor treatment arms. The A3921133 trial is continuing and is still blinded, but the design has been modified so that participants will no longer be getting the higher dose.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins