At the 13th Congress of the European Crohn’s and Colitis Organization (ECCO) – Inflammatory Bowel Diseases (IBD) in Vienna, Austria, which took place from February 14–17, Takeda announced real-world data that evaluated the effectiveness of Entyvio (vedolizumab) versus tumor necrosis factor (TNF) alpha inhibitors for patients suffering from moderate to severe ulcerative colitis (UC). The study was conducted by the Vedolizumab Health OuTComes in InflammatORY Bowel Diseases (VICTORY) consortium. The compiled analyses showed that patients treated with Entyvio had statistically significant, higher rates of mucosal healing and clinical remission compared with those treated with TNF alpha inhibitors. With the arrival of this new data, the question becomes whether or not physicians should consider using Entyvio as a first-line biologic for UC.
UC is a chronic inflammatory disease of the colon or large intestine that usually initially manifests in the terminal part of the colon (rectum) and extends either to the left part of the colon or to the entire colon as the disease progresses. According to GlobalData, there were over 1,754,677 diagnosed prevalent cases of moderate to severe UC globally in 2017, across all ages. When patients fail to respond to conventional therapies, physicians prescribe biologics such as TNF alpha inhibitors—including Johnson & Johnson’s (J&J’s) Remicade (infliximab), AbbVie’s Humira (adalimumab), and J&J’s Simponi (golimumab). Takeda’s anti-integrin therapy, Entyvio, is usually prescribed as a second-line biologic for patients who are unresponsive to TNF alpha inhibitor therapy; one reason for this may be the price, as US key opinion leaders (KOLs) interviewed by GlobalData have suggested that many hospitals do not prescribe the drug because its cost is too high.
Data from 334 patients out of the 646 UC patients in the VICTORY consortium study was analysed. Patients treated with Entyvio had higher mucosal healing and clinical remission rates compared to those treated with TNF alpha inhibitors (Entyvio: 50% versus 42%; hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.10–2.73) (TNF alpha inhibitors: 54% versus 37%; HR 1.54, 95% CI 1.08–2.18). This data reveal that Entyvio is more efficacious than anti-TNF alpha agents for this set of patients with moderate to severe UC. KOLs interviewed by GlobalData indicated that an increasing number of gastroenterologists are starting to prescribe Entyvio as a first-line biologic. As such, the data above could potentially influence these physicians to prescribe Entyvio to patients. Furthermore, one European KOL suggested that Entyvio is a better choice because of its superior safety profile compared with TNF inhibitor agents, which also makes patients more willing to use the drug.
Currently, Takeda is sponsoring an ongoing Phase III, double-blind, multicentre trial to evaluate the efficacy and safety of Entyvio compared to Humira. Positive results from this trial would reinforce the analyses that were compiled by VICTORY. Additionally, Entyvio could obtain a larger share of the UC market and become a first-line biologic if it boasted a superior efficacy profile over Humira. Therefore, it is very important for Takeda to be successful in this trial before competitor molecules such as Roche’s etrolizumab reach the market and erode Entyvio’s sales.