Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial.

ABSTRACT:

Background

Health-related quality of life (HRQL) is often diminished in patients with ulcerative colitis.

Aim

To evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis.

Methods

Using maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of patients meeting minimal clinically important difference (MCID) thresholds for changes on these instruments were compared between treatment groups for the overall population and for clinically important subgroups. Concordance b

SUBMITTER: Feagan BG 

PROVIDER: S-EPMC5215718 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature