Increased pulmonary embolism and mortality risk with 10mg Xeljanz

21 February 2019

Pfizer (NYSE: PFE) has been forced to move patients off the 10mg twice daily dose of its rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) in a post-marketing requirement study.

Patients have been transitioned to the 5mg twice daily program after the Data Safety Monitoring Board (DSMB) made Pfizer aware of a safety signal regarding the10mg treatment arm, namely that there was a statistically and clinically important difference in the occurrence of pulmonary embolism versus the tumor necrosis factor inhibitor (TNFi) control group.

An increase in overall mortality in the 10mg treatment group was also noted compared to the 5mg and TNFi arms.

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