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.
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.
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.
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
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.
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.
The clinical benefits of tofacitinib in combination with methotrexate are sustained over 2 years among patients with rheumatoid arthritis (RA), according to a study published online January 22 in Arthritis & Rheumatology.
ACR/ARHP Annual Meeting 2015
Clinical efficacy of the oral Janus kinase inhibitor tofacitinib at Month 6 was greater than placebo and "appeared similar regardless of methotrexate dose" in patients with rheumatoid arthritis a post-hoc analysis presented at the 2015 ACR/ARHP Annual Meeting has found.
Tofacitinib is superior for patients with inadequate response to TNF inhibitors or conventional DMARDs