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 74 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.
News
Tofacitinib Improves Rheumatoid Arthritis Treatment Response
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
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.
News
Tofacitinib Superior to Placebo for Rheumatoid Arthritis
For patients with rheumatoid arthritis, a novel oral Janus kinase inhibitor, tofacitinib, is associated with reduced symptoms when used as monotherapy or in addition to background methotrexate.
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 Effective for Moderate-to-Severe Ulcerative Colitis
A total of 18.5% patients taking tofacitinib experienced a remission of their condition in 8 weeks compared to just 8.2% of patients receiving placebo.
Drug News
Top-Line Results for Tofacitinib in Psoriatic Arthritis Announced
Pfizer announced top-line results from its first Phase 3 study, OPAL Broaden, evaluating the efficacy and safety of tofacitinib for the treatment of active psoriatic arthritis (PsA) in adults who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.
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…
Drug News
Tofacitinib vs. Methotrexate for Rheumatoid Arthritis
Tofacitinib is superior to methotrexate in treating rheumatoid arthritis, but increased side effects were seen with tofacitinib, including development of herpes zoster.
