Shots:

• The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg- bid and 10mg- bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor
• The primary analyses include 135 subjects with MACE and 164 subjects with malignancies. The results demonstrated the study failed to meet its co-primary endpoints i.e. non-inferiority of tofacitinib compared to TNFi in regard to MACE and malignancies (NMSC)
• Pfizer is working with the US FDA and other regulatory agencies to review the full results and analyses as they become available.

 ­ Ref: Pfizer | Image: Pfizer