BioCentury
ARTICLE | Clinical News

Pfizer reports increase in lung clots, death with high-dose Xeljanz in postmarket study

February 20, 2019 10:49 PM UTC

Pfizer Inc. (NYSE:PFE) disclosed an increase in pulmonary embolisms and deaths among rheumatoid arthritis patients receiving the twice-daily 10 mg dose of Xeljanz tofacitinib in the A3921133 postmarketing CV safety trial. The pharma said Tuesday it is moving patients in the study to twice-daily 5 mg Xeljanz, the FDA-approved dose for RA.

According to the company, an independent DSMB reported a "statistically and clinically important" difference in the occurrence of PE in patients receiving the twice-daily 10 mg dose of Xeljanz compared with patients treated with TNFα inhibitors Humira adalimumab or Enbrel etanercept. The DSMB also found an increase in overall mortality in the high-dose Xeljanz arm compared with the twice-daily 5 mg Xeljanz arm and the TNFα inhibitor arms...