P570 Improvements in subcomponents of the inflammatory bowel disease questionnaire in patients treated with vedolizumab: Results from GEMINI trial data

Abstract

Background: Vedolizumab (VDZ) is a gut-selective humanised immunoglobulin (Ig) G1 monoclonal antibody that binds to alpha4beta7 integrin and is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). The GEMINI 1 and 2 trials demonstrated improved health-related quality of life in VDZ-treated patients compared with those given placebo (PLA), based on overall scores from the Inflammatory Bowel Disease Questionnaire (IBDQ). We analysed individual subcomponents of the IBDQ to identify those associated with the greatest improvements after VDZ treatment. Method(s): A post hoc analysis of data from the GEMINI 1 and 2 trials was performed on the intent-to-treat population, comparing patients receiving PLA with those receiving VDZ (patients dosed every 4 and 8 weeks were combined for the maintenance phase). Baseline disease characteristics were similar across groups in each trial. Each question on the IBDQ was scored from 1 to 7, with higher values indicating better function. Questions assessing social function (days of work/school missed, limited sexual activity), emotional function (feelings of frustration, satisfaction, anxiety, depression) and systemic symptoms (fatigue, energy levels, quality of sleep, feeling unwell) were selected for analysis. Changes from baseline in IBDQ scores at Weeks 6 and 52 were calculated and presented as forest plots, using Dunnett's method to generate confidence intervals. Result(s): Data were analysed for patients with UC (Week 6 [VDZ n = 219, PLA n = 144]; Week 52 [VDZ n = 164, PLA n = 58]) and for patients with CD (Week 6 [VDZ n = 212, PLA n = 146]; Week 52 [VDZ n = 171, PLA n = 82]). Early improvement was reported in all IBDQ subdomains at Week 6 and sustained up to Week 52 by patients with UC (Figure 1a). Patients with CD reported improvement in anxiety, depression, frustration, and sexual activity at Week 6, and fatigue, sleep, and energy levels at Week 52 (Figure 1b). All patients reported significant improvement in general well-being at both time points. Conclusion(s): Early improvements with VDZ treatment were reported for sexual activity, anxiety, depression, and frustration, whereas long-term benefits were reported for general well-being, sleep, fatigue, and energy levels. Improvement was greater for all other subcomponents of the IBDQ with VDZ compared with PLA; however, these results were not statistically significant.