Patients treated with JAK inhibitors for rheumatoid arthritis may be less likely to have low disease activity if they are obese compared with those who are overweight.
Your search for tofacitinib returned 61 results
The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.
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.
The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.
In this post hoc analysis, researchers explored whether anemia was a predictor of radiographic progression in patients with RA who were treated with tofacitinib.
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
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
Xeljanz and Xeljanz XR are Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate.
An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.
Sandborn, WJ et al. “Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis.” DOI: 10.1056/NEJMoa1606910