Tofacitinib fails to meet co-primary endpoint in post-marketing safety study in rheumatoid arthritis (RA)

In patients >50yrs with RA and one additional CV risk factor, the criteria for non-inferiority of tofacitinib (combined doses) compared to a TNF inhibitor for major adverse cardiovascular events (HR 1.33; 95% CI 0.91-1.94) and malignancies (1.48; 1.04-2.09) were not met.

SPS commentary:

The required post-marketing study (ORAL Surveillance) was specifically designed to assess the risk of cardiovascular events and malignancies. Pfizer is working with regulatory agencies to review the full results and analyses as they become available.

Biospace Inc.