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.
Your search for tofacitinib returned 10 results
Incidences of major adverse cardiovascular events, cancers higher with tofacitinib versus TNF inhibitor; criteria for noninferiority not met
Results of the ORAL Surveillance study showed a higher risk for major adverse CV events and venous thromboembolism with tofacitinib vs TNFis.
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
No reduction in ADRD risk seen for treatment with tofacitinib, tocilizumab, TNF inhibitors versus abatacept
JAK inhibitor baricitinib strongly recommended for the treatment of severe or critical COVID-19
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.
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.
The data were compared with the 2018 ACG and 2020 AGA guidelines for UC and the 2019 ACG and 2021 AGA guidelines for CD.
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