P071 The Impact of VARSITY Clinical Trial Data Awareness on Prescribing Behavior in Ulcerative Colitis
Authors: Price Lynn , Schmitt Lauren 
Published: December 2019

BACKGROUND:
TNF inhibitors have long been the standard of care for patients with Ulcerative Colitis (UC) and Crohn’s disease (CD), however, with the arrival of alternative mechanism of action agents, TNF use has been slowly declining. In Takeda’s head-to-head clinical trial, VARSITY, vedolizumab demonstrated superiority over adalimumab for patients with moderate to severe UC regarding the percent of patients achieving clinical remission and mucosal healing after 52 weeks. This research sought to demonstrate the impact that awareness of VARSITY trial data has on use of vedolizumab and adalimumab for the treatment of IBD.

METHODS:
An independent market analytics firm collaborated with US gastroenterologists (n = 97) to conduct analysis on the IBD market. Data collected from the participating gastroenterologists include demographics, prescribing behavior, and attitudinal survey responses. Data were collected in August and September 2019. Responding gastroenterologists were required to predominantly treat adult patients, have at least 50 IBD patients under their management, and spend at least half of their professional time in clinical practice.

RESULTS:
65% of gastroenterologists reported awareness of the VARSITY trial data prior to participation in the study. After prompting of the clinical trial results, 45% of gastroenterologists reported the data will have a strong positive impact on their vedolizumab prescribing behavior for the treatment of UC, while just 16% reported that the results will have a strong negative impact on their use of adalimumab. Furthermore, 65% of participating gastroenterologists agree with the statement: “based on the VARSITY data, I believe vedolizumab is more efficacious than adalimumab for the treatment of UC” with an additional 58% agreeing that, “the VARSITY data will likely lead me to prescribe more vedolizumab and less adalimumab when treating UC.” Indeed, an analysis of the last five biologic or JAK prescriptions written for the treatment of UC reveals that use of vedolizumab was significantly greater for those aware of the VARSITY data than those not aware (33% vs 18%). Six month projected use of vedolizumab in UC was also significantly greater for those aware of the VARSITY data (29% vs 19%). Conversely, recent use and six month projected use of adalimumab in UC was not statistically different between those aware of the trial and those unaware, respectively (percent of last five prescriptions: 25% vs 32%; percent of six month projected use: 25% vs 30%). Despite not being conducted for patients with Crohn’s disease, the VARSITY data still possesses a positive impact in Crohn’s disease, although to a lesser extent.

CONCLUSION(S):
Awareness of the VARSITY clinical trial data has a positive effect on use of vedolizumab in UC. Those aware of the data have used significantly more vedolizumab with regard to their most recent biologic/JAK prescriptions for UC and also project significantly greater future use of the brand over the next six months compared to those unaware. However, the positive effect on vedolizumab does not come at the expense of adalimumab; despite the VARSITY data demonstrating superiority of vedolizumab over adalimumab, use of adalimumab with regard to new prescriptions and future projected use are unaffected, regardless of awareness status.