Tofacitinib as Induction and Maintenance Therapy in Japanese Patients with Active Ulcerative Colitis.

ABSTRACT:

Background

Tofacitinib is an oral, small molecule Janus kinase inhibitor approved in Japan for the treatment of ulcerative colitis (UC). 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.

Objectives

We conducted post hoc analyses of tofacitinib treatment in Japanese patients with moderate-to-severe UC in two global phase III studies.

Methods

In OCTAVE Induction 1 (NCT01465763), 62 patients were randomized to placebo or tofacitinib 10 mg twice daily (b.i.d.). 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. Efficacy endpoints included: remission (primary end

SUBMITTER: Suzuki Y 

PROVIDER: S-EPMC6873059 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature