Results of the ORAL Surveillance study showed a higher risk for major adverse CV events and venous thromboembolism with tofacitinib vs TNFis.
The data were compared with the 2018 ACG and 2020 AGA guidelines for UC and the 2019 ACG and 2021 AGA guidelines for CD.
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
Drugs in the Pipeline
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.
Safety Alerts and Recalls
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.