Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.

ABSTRACT: Background:Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib is approved for rheumatoid arthritis and psoriatic arthritis, where it has been shown to increase herpes zoster (HZ) risk. We evaluated HZ risk among UC patients using tofacitinib. Methods:HZ cases were identified in tofacitinib phase II/III/ongoing, open-label, long-term extension (OLE) UC trials. We calculated HZ incidence rates (IRs) per 100 patient-years of tofacitinib exposure within phase III maintenance (Maintenance Cohort) and phase II/III/OLE (Overall Cohort) studies, stratified by baseline demographics and other factors. HZ risk factors were evaluated in the Overall Cohort using Cox proportional hazard models. Results:Overall, 65 (5.6%) pati

SUBMITTER: Winthrop KL 

PROVIDER: S-EPMC6140434 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature