SAN DIEGO — Patients with ulcerative colitis treated with the subcutaneous formulation of vedolizumab demonstrated substantial improvements in symptoms, quality of life and work productivity, according to a study presented at Digestive Disease Week.
“Patients with ulcerative colitis experience substantial impairment in quality of life,” Severine Vermeire, MD, PhD, from the University Hospitals Leuven, Belgium, and colleagues wrote. ”Quality-of-life endpoints are therefore considered important measures of treatment outcome.”
In the phase 3, placebo-controlled VISIBLE 1 trial, Vermeire and colleagues aimed to determine how an investigational subcutaneous formulation of Entyvio (vedolizumab, Takeda) affects quality of life and work productivity in patients with moderately to severely active UC.
Participants received 300 mg vedolizumab IV at baseline and week 2 during the open-label induction phase of the trial. At week 6, patients who achieved a clinical response (n = 216) were randomly assigned to maintenance phase treatment with either 108 mg subcutaneous vedolizumab every 2 weeks, 300 mg IV vedolizumab every 8 weeks or placebo.
The researchers used the Inflammatory Bowel Disease Questionnaire (IBDQ) and Euro Quality of Life-5D visual analog scale (EQ-5D VAS) to assess quality of life and Work Productivity and Activity Impairment (WPAI-UC) to assess work productivity. They used a covariance model to compare changes in quality of life and work productivity between the three treatment groups from baseline (week 0) to week 52 and from week 6 to week 52 in the maintenance phase.
At week 52, the mean total IBDQ scores were 180.7 for patients receiving subcutaneous vedolizumab, 170.7 for patients receiving IV vedolizumab and 135.2 for patients receiving placebo. Patients treated with subcutaneous vedolizumab (+65.3) and IV vedolizumab (+58.6) showed significant improvements in IBDQ scores from baseline to week 52 compared with placebo (P < .001 for both).
Mean EQ-5D VAS scores at week 52 were 76.1 for patients receiving subcutaneous vedolizumab, 71.4 for patients receiving IV vedolizumab and 58.1 for patients receiving placebo. Patients treated with both subcutaneous vedolizumab and IV vedolizumab demonstrated significantly greater changes in EQ-5D VAS scores over the course of the study (+27.1 and +22.6, respectively) than those treated with placebo (P .001 for both).
Additionally, in both vedolizumab groups, improvements in mean WPAI-UC subscores were greater than placebo.
These improvements in IBDQ, EQ-5D VAS and WPAI-UC scores were sustained throughout the study in both vedolizumab arms. Patients receiving maintenance treatment with placebo showed notable worsening in quality of life and work productivity measures from week 6 to week 52.
“Further investigation of the effects of vedolizumab subcutaneous on quality of life is needed to validate these findings,” Vermeire and colleagues concluded. – by Alaina Tedesco
Vermeire S, et al. Sa1878. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosure: Vermeire reports no relevant financial disclosures. Please see the abstract for all other authors’ relevant financial disclosures.