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VERSIFY substudy demonstrates benefits of IV Entyvio
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SAN DIEGO — Patients with Crohn’s disease treated with IV Entyvio demonstrated considerable improvements in quality of life and work productivity, according to a study presented at Digestive Disease Week.
“The open-label, phase 3b, single-arm VERSIFY trial demonstrated that IV Entyvio (vedolizumab, Takeda) induced endoscopic healing in patients with moderately to severely active Crohn’s disease,” Silvio Danese, MD, PhD, head of the IBD Center at Humanitas University, Milan, Italy, and colleagues wrote.
Danese and colleagues conducted a substudy of the VERSIFY trial to determine how IV vedolizumab affects quality of life and work productivity over the duration of 1 year (n = 56; mean age, 39.6 years; 54% men). Of the included patients, 43% were previously treated with anti-TNF alpha therapy.
The researchers used the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Euro Quality of Life-5D (EQ-5D) utility index and visual analog scale to evaluate quality of life. The Work Productivity and Activity Impairment (WPAI-CD) assessment was used to evaluate work productivity.
Remission was defined as having a total IBDQ score of 170 points or greater. An increase of 16 or more points on the IBDQ were deemed clinically important. Endoscopic remission status and previous exposure to anti-TNF alpha therapy was used to assess outcomes.
By the end of the study, endoscopic remission was achieved by 29% of patients.
All subgroups demonstrated increases in IBDQ total score by week 14. These improvements were sustained throughout the study duration.
Patients with endoscopic remission showed greater improvements in IBDQ total score (183 vs. 164), EQ-5D utility index (0.91 vs. 0.83) and visual analog scale (79 vs. 68). Endoscopic remission was also associated with continual increases in WPAI-CD subscores.
Patients with no previous exposure to anti-TNF alpha therapy had greater improvements in IBDQ total score (178 vs. 157). Improvements in EQ-5D were observed irrespective of prior anti-TNF alpha use at week 52. Patients naive to anti-TNF alpha had modestly greater EQ-5D visual analog scale scores compared with those who failed anti-TNF alpha therapy before.
Lack of prior exposure to anti-TNF alpha therapy was associated with markedly improvements in work impairment and daily activities impairment.
“Overall, IV vedolizumab treatment was associated with substantial improvements in both quality of life instruments and work productivity measures,” Danese and colleagues concluded. – by Alaina Tedesco
Reference:
Danese S, et al. Sa1881. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosure: Danese reports consulting for Allergan, Amgen, AstraZeneca, Biogen, Boheringer Ingelheim, Celgene, Celltrion, Ferrin Pharmaceuticals Inc., Gilead, Hospira, Janssen, Johnson & Johnson, Roche, Sandoz, Takeda, TiGenix, UCB Inc. and Vifor.