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.
The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Patients treated with tofacitinib experienced significantly fewer disease flares compared with placebo.
Several treatments were attempted but failed to manage the patient’s conditions, including proton pump inhibitors, topical steroids, a restricted diet, and infliximab (3 doses) for arthritis.
The FDA has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis.
The patient had been diagnosed with mild-to-moderate ulcerative colitis (UC) a month prior to presentation for which she was prescribed oral mesalamine.
The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting. Combination biologic therapy may…