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
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.
Drugs in the Pipeline, News
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Sandborn, WJ et al. "Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis." DOI: 10.1056/NEJMoa1606910
The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Safety Alerts and Recalls
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…
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.