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P374 Effects of subcutaneous vedolizumab on health-related quality of life and work productivity in patients with ulcerative colitis: results from the Phase 3 VISIBLE 1 trial

2019; Oxford University Press; Volume: 13; Issue: Supplement_1 Linguagem: Inglês

10.1093/ecco-jcc/jjy222.498

1876-4479

Séverine Vermeire, Željko Krznarić, Taku Kobayashi, Jingjing Chen, Christian Agboton, Krisztina Kisfalvi, Haridarshan Patel, William J. Sandborn,

Microscopic Colitis

Patients with ulcerative colitis (UC) experience substantial impairment in quality of life (QOL), and QOL endpoints are therefore considered important measures of treatment outcome. We evaluated the effects of an investigational vedolizumab (VDZ) subcutaneous (SC) formulation on QOL and work productivity in VISIBLE 1 (NCT02611830; EudraCT 2015-000480-14), a Phase 3, placebo-controlled trial that demonstrated the efficacy and safety of VDZ SC in moderately to severely active UC. Following an open-label induction phase (VDZ intravenous [IV] 300 mg at Weeks 0 and 2), patients who achieved clinical response at Week 6 were randomised to maintenance phase treatment with: VDZ SC 108 mg every 2 weeks, VDZ IV 300 mg every 8 weeks, or the matching placebo (SC and IV). QOL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS), and work productivity using Work Productivity and Activity Impairment (WPAI-UC). Changes in QOL and work productivity from baseline (Week 0) to Week 52 and from Week 6 to Week 52 in the maintenance phase were compared between the three treatment groups using an analysis of covariance model (covariate: baseline score). There were 216 patients randomised at Week 6. Mean total IBDQ scores at Week 52 were: placebo, 135.2; VDZ SC, 180.7; VDZ IV, 170.7. Scores were significantly improved from baseline with both VDZ SC (+65.3) and VDZ IV (+58.6) compared with placebo (p < 0.001 for both) (Figure 1A). Mean EQ-5D VAS scores at Week 52 were: placebo, 58.1; VDZ SC, 76.1; VDZ IV, 71.4; change from baseline was significantly greater for VDZ SC (+27.1) and VDZ IV (+22.6) compared with placebo (p ≤ 0.001 for both) (Figure 1B). Similarly, improvements in mean WPAI-UC subscores were consistently greater with both VDZ SC and VDZ IV vs. placebo (Figure 1C). Improvements in IBDQ, EQ-5D VAS, and WPAI-UC scores observed at Week 6 were sustained through Week 52 with VDZ both VDZ SC and VDZ IV (Figure). Across all QOL and work productivity measures, patients who received maintenance placebo had substantial worsening in scores from Week 6 to Week 52 (Figure 1A–C). VDZ SC treatment was associated with overall significantly meaningful clinical improvements in IBDQ and EQ-5D VAS QOL instruments. Similarly, significant improvements in work productivity measures were observed among patients treated with VDZ SC. Further investigation of the effects of VDZ SC on QOL is needed to validate these findings. Figure 1. Changes in (A) IBDQ, (B) EQ-5D VAS, and (C) WPAI-UC scores from Week 0 to Week 52 and Week 6 to Week 52 in the three maintenance treatment groups.