Treatment with Entyvio (vedolizumab), delivered into the blood or under the skin, led to significant clinical improvements and in quality of life, as well as work productivity in patients with moderate-to-severe ulcerative colitis, a Phase 3 clinical trial showed.
The results were presented in a poster titled “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,” at the 14thCongress of ECCO, March 6-9 in Copenhagen, Denmark.
The quality of life of patients with UC is often impaired, and clinical trials testing investigational therapies for UC also should include the therapy’s effects on this important outcome.
Researchers analyzed data from the Phase 3 VISIBLE 1 trial, evaluating Takeda Pharmaceutical’s new subcutaneous (under-the-skin) form of Entyvio to assess the therapy’s effects in the UC patient’s quality of life and work productivity.
The VISIBLE 1 (NCT02611830) recruited adult patients with moderate-to-severe UC who already had achieved a meaningful clinical response after receiving two doses of intravenous (injected into the blood) Entyvio, compared to a placebo.
The trial evaluated the safety and effectiveness of Entyvio administered subcutaneously as a maintenance therapy. All patients first received a 300 mg infusion of Entyvio for six weeks (induction phase).
Those showing a clinical response entered a maintenance phase in which they were randomized to one of three groups; group 1 received Entyvio administered subcutaneously at 108 mg (every two weeks) followed by intravenous placebo; group 2 received an intravenous injection of Entyvio at 300 mg (every eight weeks) followed by subcutaneous placebo injection; group 3 received a placebo only (first administered subcutaneously followed by intravenous injection).
Quality of life was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Work productivity was measured with the Work Productivity and Activity Impairment (WPAI-UC) questionnaire at the end of induction phase and after 52 weeks (maintenance phase).
In total, 216 patients were included in the maintenance phase. After 52 weeks, the total IBDQ scores improved in both groups treated with Entyvio, with scorings improving by 65.3 and 58.6 points in the subcutaneous and intravenous treated groups, respectively, compared to the placebo group. By week 52, the mean total IBDQ scores were 180.7 (Entyvio subcutaneously) and 170.7 (Entyvio intravenously) and 135.2 (placebo group).
The mean EQ-5D VAS scores at week 52 also improved significantly, with Entyvio’s subcutaneous- and intravenous-treated groups showing an increase of 27.1 and of 22.6 points relative to the placebo group.
Work productivity and the ability to perform activities also were significantly enhanced with Entyvio.
The improvements in IBDQ, EQ-5D VAS, and WPAI-UC were already seen at the end of induction phase and were maintained through Week 52, while patients in the placebo group continued to worsen.
Previous results had shown that a significantly higher proportion of patients treated with subcutaneous Entyvio achieved clinical remission, compared to those treated with a placebo (46.2% vs 14.3%), at week 52. The rate of clinical remission was similar to the one observed among patients who were treated with intravenous Entyvio (300 mg, every eight weeks) at week 52 (42.6%).
Overall, these results show that in parallel to the improvements in clinical remission, treatment with Entyvio also leads to meaningful improvements in UC patients’ quality of life and work productivity.
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