In Japan, the prevalence of UC is 0.16–1.95 cases per 100,000 person-years. UC can have a considerable impact upon patients’ quality of life and imposes a significant health burden, requiring optimum disease management to improve clinical outcomes. Ulcerative colitis (UC) is a chronic inflammatory disease of the gastrointestinal tract, characterized by alternating periods of disease activity and remission. Conclusions: Although patient numbers were small, tofacitinib demonstrated numerically greater efficacy versus placebo among Japanese patients in OCTAVE Induction 1 and OCTAVE Sustain, with a safety profile consistent with that of the global study population.
The occurrence of AEs or serious AEs in Japanese patients was generally similar to that in the global study population, with no new or unexpected safety risks observed. At week 52 of OCTAVE Sustain, 31.3% and 66.7% of patients receiving tofacitinib 5 and 10 mg b.i.d., respectively, achieved remission (placebo, 9.1%). Results: At week 8 of OCTAVE Induction 1, 22.4% of patients achieved remission with tofacitinib (placebo, 7.7%). Adverse events (AEs) and clinical laboratory parameters were recorded. Efficacy endpoints included: remission (primary endpoint total Mayo score ≤2 no individual subscore >1 rectal bleeding subscore 0) mucosal healing (Mayo endoscopic subscore ≤1) clinical response (≥30% and ≥3-point decrease from induction study baseline total Mayo score decrease in rectal bleeding subscore ≥1 or absolute subscore ≤1). In OCTAVE Sustain (NCT01458574), 39 patients with clinical response in OCTAVE Induction 1 were re-randomized to placebo, tofacitinib 5 mg, or 10 mg b.i.d. Methods: In OCTAVE Induction 1 (NCT01465763), 62 patients were randomized to placebo or tofacitinib 10 mg twice daily (b.i.d.). Objectives: We conducted post hoc analyses of tofacitinib treatment in Japanese patients with moderate-to-severe UC in two global phase III studies.
Differences in the safety profile of tofacitinib in Japanese patients versus the global population, such as a higher risk of herpes zoster, have been reported. Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor approved in Japan for the treatment of ulcerative colitis (UC).