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.
Infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, ustekinumab recommended over no tx
ACR 2019, News
Researchers compared the risk for serious infections in offspring of mothers with chronic inflammatory diseases who received non-TNFi biologics or tofacitinib during pregnancy vs offspring who were unexposed, but exposed to TNFi in utero.
TNFi recommended over secukinumab, ixekizumab for AS and nonradiographic axial SpA as first biologic