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 between clinical remission and remission defined using IBDQ scores was examined. RESULTS: Compared with placebo-treated patients, vedolizumab-treated patients had greater improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients than placebo-treated patients met MCID thresholds for all the instruments. Vedolizumab-treated patients with lower baseline disease activity and those without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL improvements. Among 127 patients with clinical remission based on complete Mayo Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ remission demonstrated clinical remission. CONCLUSIONS: Vedolizumab therapy was associated with significant improvements in HRQL measures compared with placebo. Benefits were greater in patients with lower disease activity and no prior TNF antagonist failure.