Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study.

ABSTRACT:

Background

Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for inflammatory bowel disease.

Aims

This 48-week open-label extension study primarily investigated long-term safety of tofacitinib 5 and 10 mg b.d. and secondarily investigated efficacy as maintenance therapy in patients with Crohn's disease.

Methods

Patients who had completed the phase 2b maintenance study, or withdrawn due to treatment failure, were enrolled. Patients in remission (Crohn's disease activity index <150) at baseline received tofacitinib 5 mg b.d.; all others received 10 mg b.d. A single dose adjustment was allowed after 8 weeks' fixed, open-label treatment.

Results

Sixty-two patients received tofacitinib 5 mg b.d.; 88 received 10 mg b.d. Both gro

SUBMITTER: Panes J 

PROVIDER: S-EPMC6646954 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature