Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

January 28, 2021 Auto Bot Clinical Trials, Pfizer, Report, results, rheumatoid arthritis, XELJANZ 0

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.

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