Tofacitinib 5mg, 10mg; tabs.
Tofacitinib 11mg, 22mg; ext-rel tabs.
Tofacitinib 1mg/mL; grape flavor; contains sucralose, xylitol.
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.
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.
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
Sandborn, WJ et al. "Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis." DOI: 10.1056/NEJMoa1606910
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.
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.