PTH-091 Effects of vedolizumab on HRQoL and work productivity in Crohn’s disease: results from versify

Introduction The open-label, phase 3b, single-arm VERSIFY trial demonstrated that intravenous (IV) vedolizumab (VDZ) induced endoscopic healing in patients (pts) with moderately to severely active Crohn’s disease (CD). We evaluated the effects of IV VDZ on quality of life (QOL) and work productivity over a 52-week study period. Methods 56 patients were enrolled into an IV vedolizumab 52-week substudy. QOL was assessed using Inflammatory Bowel Disease Questionnaire (IBDQ) and Euro Quality of Life-5D (EQ-5D) utility index and visual analogue scale (VAS), and work productivity using Work Productivity and Activity Impairment (WPAI-CD). For the 52-week substudy population (n=56), changes over 52 weeks were evaluated. IBDQ remission was considered as a total IBDQ score of ≥170 points, with an improvement of ≥16 points considered clinically meaningful. Outcomes were examined by endoscopic remission status and by prior anti-tumour necrosis factor-alpha (anti-TNFα) use. Results Mean pt age was 39.6 years, 54% were male, 43% had prior anti-TNFα treatment and 29% achieved endoscopic remission at any ileocolonoscopy visit up to Week 52. Improvements in IBDQ total score were observed as early as Week 14 and were sustained up to Week 52. At week 52 improvements were greater in pts with endoscopic remission (183 vs 164, table 1) and in pts with no prior anti-TNFα use (178 vs 157, table 1). Similar trends of greater improvements in EQ-5D utility index (0.91 vs 0.83) and VAS (79 vs 68) were observed at Week 52 in pts with endoscopic remission. At Week 52, EQ-5D utility scores improved equally regardless of prior anti-TNFα use, whereas EQ-5D VAS scores were slightly higher in pts naive to anti-TNFα vs those who had previously failed anti-TNFα treatment. Improvements in WPAI-CD subscores were consistently higher in pts with endoscopic remission; overall work impairment and daily activities impairment were substantially improved in pts naive to anti-TNFα. Conclusions Overall, IV VDZ treatment was associated with substantial improvements in both QOL instruments and work productivity measures. The improvements in QOL and work productivity were greater among pts who achieved endoscopic remission and pts who had no prior anti-TNFα treatment.