News
Xeljanz/Xeljanz XR Approved for Active Ankylosing Spondylitis
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 43 results
News
Xeljanz Gets FDA Committee Nod for Ulcerative Colitis Indication
The GIDAC recommendations are provided to the FDA but they are not binding. The FDA has set a target PDUFA action date of June 2018.
Safety Alerts and Recalls
Boxed Warning Added to Tofacitinib Prescribing Information
The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen. The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…
Drugs in the Pipeline, News
Tofacitinib Ext-Rel Monotherapy Effective for Moderate to Severe RA After Methotrexate Withdrawal
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Drugs in the Pipeline
Tofacitinib Effective in Phase 3 Psoriasis Retreatment Study
Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
News
Tofacitinib vs TNFi for RA: Safety Study Results Announced
The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Drugs in the Pipeline
Tofacitinib Demonstrates Efficacy for Potential UC Indication
Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).
Drugs in the Pipeline
Xeljanz Demonstrates Efficacy in Chronic Plaque Psoriasis
Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
News
Arthritis Drug May Help Eczema Patients, Too
A drug used to treat rheumatoid arthritis (RA) was effective in patients with moderate to severe eczema, according to a study conducted by researchers from Yale School of Medicine.
Drugs in the Pipeline
Phase 3 Trial Update of Tofacitinib for Rheumatoid Arthritis
Pfizer announced top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib in the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).
