Xel 3 food backgrounds trial#

6a,6b The trial met its primary endpoint showing that in patients with pcJIA who achieved a juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response at the end of the run-in phase, the occurrence of disease flare in patients treated with tofacitinib (31 percent n/N=27/88) was statistically significantly (p=0.0007) lower than patients treated with placebo (55 percent n/N=47/85) at week 44. The study evaluated the efficacy and safety of tofacitinib taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily based on the subject’s body weight (<40 kg for the oral solution) and/or patient preference. This approval was based on data from a Phase 3 study including two phases: an 18-week open-label, run-in phase (including 225 patients), followed by a 26-week double-blind, placebo-controlled, randomized, withdrawal phase (including 173 patients) for a total duration of 44 weeks. The FDA approval of Xeljanz for pcJIA is positive news for this community as it provides a new advanced treatment option in an oral formulation.” 2a,2b,3a,4a,5a,5b,5c

These can be quite burdensome to both children with pcJIA and their caretakers. “Although there arealready several advanced treatments available, tofacitinib will be an appealing new option given it does not require injectionsor infusions. Hermine Brunner, Director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and Scientific Director of the Pediatric Rheumatology Collaborative Study Group. “Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant jointpain and limit participation in child appropriate activities,” said Dr.

Xel 3 food backgrounds