Trial Tracker
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
ACR/ARHP Annual Meeting 2013
Changing directly from adalimumab to tofacitinib sustained clinical response and improved ACR response rates in patients with rheumatoid arthritis, an open-label extension study presented at the 2013 ACR/ARHP Annual Meeting has found.
News
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.
News
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
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.
ACR/ARHP 2018 Annual Meeting
Although the incidence rate of venous thromboembolism was numerically higher in patients treated with tofacitinib vs TNF inhibitors, the risk was not statistically significant.
News
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.
Drugs in the Pipeline, News
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Trial Tracker
Sandborn, WJ et al. "Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis." DOI: 10.1056/NEJMoa1606910
News
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
