DOP076. Improvements in health-related quality of life in patients with ulcerative colitis treated with vedolizumab
B. Feagan1, J.-F. Colombel2, D. Rubin3, R. Mody4, S. Sankoh5, K. Lasch6, 1Western University/Robarts Research Institute, Robarts Clinical Trials Inc, London, Ontario, Canada, 2Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, United States, 3The University of Chicago Medicine, Gastroenterology, Chicago, United States, 4Takeda Pharmaceuticals International, Inc., Global HEOR, Deerfield, United States, 5Takeda Pharmaceuticals International Company, Global Statistics, Cambridge, United States, 6Takeda Pharmaceuticals International Company, GI/Medical Affairs, Cambridge, United States
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.
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-carried-forward method.
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.
|Change from baseline to Week 6|
(end of induction phase)
|Change from baseline to Week 52|
(end of maintenance phase)
|PBO (N = 149)||VDZ (N = 225)||Between-group difference b||PBO (N = 126)||VDZ Q8W (N = 122)||Between-group difference b||VDZ Q4W (N = 125)||Between-group difference b|
|SF-36 PCS score||1.4 (0.3, 2.4)||4.0 (3.1, 4.9)||2.6 (1.3, 4.0)||4.5 (3.2, 5.8)||7.9 (6.6, 9.2)||3.3 (1.5, 5.2)||7.3 (6.0, 8.6)||2.8 (1.0, 4.6)|
|SF-36 MCS score||−0.2 (−1.6, 1.3)||4.4 (3.1, 5.6)||4.5 (2.6, 6.4)||3.9 (2.2, 5.7)||8.7 (6.9, 10.5)||4.7 (2.3, 7.2)||8.7 (7.0, 10.5)||4.8 (2.3, 7.2)|
|EQ-5D VAS score||0.6 (−2.3, 3.5)||10.2 (7.8, 12.6)||9.6 (5.8, 13.4)||9.7 (6.4, 13.0)||19.0 (15.6, 22.3)||9.3 (4.6, 14.0)||19.4 (16.1, 22.7)||9.7 (5.0, 14.4)|
|a Data are presented as adjusted mean change (95% CI); adjusted for baseline value.|
b Between-group difference = adjusted mean change for VDZ − adjusted mean change for PBO.
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.
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