The results of the VARSITY trial, a head-to-head Phase IIIb double-blind, double-dummy, multicentre, active controlled study, that evaluates the efficacy and safety of Entyvio, compared to Humira in patients with moderate to severe ulcerative colitis (UC), were announced at the ECCO Conference 2019 in Copenhagen.
Following this, Patrick Aiyes, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on Entyvio’s future prospects:
“Entyvio will most likely be the dominant drug in the UC landscape. In the overall analysis of the VARSITY trial after a year, 31.3% of patients suffering from moderate to severe UC achieved clinical remission whilst using Entyvio, compared to 22.5% of patients using Humira. Entyvio also boasted a superior safety profile than Humira with 62.7% and 69.2% respectively, experiencing an adverse event. As its mechanism of action shows both superior efficacy and safety results compared to Humira which is an anti-TNF similar to Remicade, it means Entyvio will most likely displace it as the most dominant medication in UC.
“There is a high likelihood after these results that Entyvio could be a first line option for patients suffering from moderate to severe UC. Furthermore, according to GlobalData’s report, ‘Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2026’ Takeda is also launching a subcutaneous (SC) version of Entyvio in 2020 and this will compete with both Humira and Simponi for patient share. GlobalData forecasts that Entyvio IV and SC will generate combined revenue of $998m by 2026, making the drug the most dominant franchise in the UC market.
“Although questions remain around unknown steroid use in the patients enrolled and the potential increase in response due to the use of low levels of steroids, the overall analysis from the VARSITY trial support the use of Entyvio ahead of Humira in patients with moderate-to-severe UC.”
* 7MM: US, France, Germany, Italy, Spain, UK, Japan.