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
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.
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
Tofacitinib, an oral inhibitor of Janus kinase 1, 2, and 3, can reduce disease severity and induce remission better than a placebo in patients with moderately to severely active ulcerative colitis.
Drugs in the Pipeline
Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).
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.
Drugs in the Pipeline
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.
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.