Improvements in health-related quality of life in patients with ulcerative colitis treated with vedolizumab

Background: In the GEMINI 1 study (NCT00783718), vedolizumab (VDZ) significantly improved Inflammatory Bowel Disease Questionnaire (IBDQ) total score in patients with ulcerative colitis (UC) compared with placebo (PBO). VDZ effects on health-related quality of life (HRQoL) were also assessed with the 36-Item Short Form Health Survey (SF-36) and EQ-5DTM visual analogue scale (VAS) for the overall population and IBDQ total and SF-36 summary scores for population subgroups based on prior anti-tumour necrosis factor (TNF) therapy status and baseline Mayo score. Methods: In weeks 0-6 of the GEMINI 1 study, patients received blinded VDZ 300 mg or PBO or open-label VDZ 300 mg at weeks 0 and 2. Week 6 responders were rerandomised to receive VDZ 300 mg every 4 weeks (Q4W) or 8 weeks (Q8W) or PBO Q4W during the maintenance phase (weeks 6-52). Changes from baseline to weeks 6 and 52 in HRQoL end points were analysed for the overall population prospectively and by baseline Mayo score (<9, ≥9) and prior anti-TNF therapy (failure, naive) as post hoc analyses. Proportions of patients with an IBDQ total score ≥170 and those with clinically meaningful increases from baseline in IBDQ total score (≥16 points) and SF-36 mental (MCS) or physical component summary scores (PCS; ≥5 points) were also assessed. Analyses used the last-observation-carriedforward method. Results: At weeks 6 and 52, VDZ patients had significant improvements from baseline in SF-36 PCS and MCS and EQ-5D VAS scores vs PBO patients (Table). VDZ improved IBDQ total and SF-36 PCS and MCS scores compared with PBO at weeks 6 and 52 for Mayo score <9 and anti-TNF-naive patient subgroups. For patients with Mayo score ≥9, VDZ improved IBDQ total and SF-36 MCS scores at week 6 and IBDQ total and SF-36 PCS and MCS scores at week 52 (Q8W only) compared with PBO. Improvements vs PBO in IBDQ total and SF-36 PCS scores were seen at week 6 in VDZ patients with prior anti-TNF failure. Proportions of patients with IBDQ total score ≥170 were higher with VDZ at week 6 and week 52 than with PBO (P <0.005) and higher proportions of VDZ-treated than PBO-treated patients had clinically meaningful increases from baseline in IBDQ total (weeks 6 and 52), SF-36 PCS (weeks 6 and 52 [Q8W only]), and SF-36 MCS (week 6) scores. Conclusions: Patients with UC treated with VDZ had significant and clinically meaningful improvements in HRQoL, as measured by both disease-specific and generic instruments, at weeks 6 and 52 compared with PBO across disease severity and in difficult-to-treat UC. (Table Presented).