The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Your search for tofacitinib returned 61 results
In patients with ulcerative colitis (UC), tofacitinib, a Janus kinase inhibitor, was associated with improved short-term efficacy, when compared with vedolizumab, an integrin receptor antagonist. Findings were presented at the Advances in Inflammatory Bowel Disease (AIBD) 2019 meeting in Orlando, Florida.
Treatment with tofacitinib appears to have little impact on extraintestinal manifestations (EIMs) in patients with moderate to severe ulcerative colitis (UC) and might even improve them, according to an analysis of the OCTAVE program. Findings were presented at the 2019 AIBD Annual Meeting in Orlando, Florida.
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…
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
In this post hoc analysis, researchers explored whether anemia was a predictor of radiographic progression in patients with RA who were treated with tofacitinib.
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
Fleischmann, R et al. “Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial.” DOI: http://dx.doi.org/10.1016/S0140-6736(17)31618-5
Xeljanz and Xeljanz XR are Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate.