Use of Entyvio will only be further bolstered if/when the brand’s new subcutaneous formulation receives the FDA green light, according to a recently published study by Spherix Global Insights

 EXTON, Pa., June 1, 2020 /PRNewswire/ — Takeda’s Entyvio has proven to be one of the leading go-to options for the treatment of ulcerative colitis (UC), even in the face of increased competition and the dramatic impact US gastroenterology practices are facing as a result of the current COVID-19 pandemic. According to the Q2 2020 report included in Spherix’s RealTime Dynamix™: Inflammatory Bowel Disease (US) service, which collected the responses of 112 US gastroenterologists, use of Entyvio in UC has shown incremental quarter over quarter gains over the past year, and the brand now joins market leaders, AbbVie’s Humira and Janssen’s Remicade, as one of the most penetrated and widely prescribed advanced systemic treatments available. More than half of sampled gastroenterologists report that they have increased their use of Entyvio for UC over the past three months, with one-third particularly indicating that the brand’s favorable safety profile and generally low risk of side-effects in the face of the current COVID-19 pandemic was at least partially responsible for that increase.

Entyvio is also benefiting from increased positive perceptions among prescribers as a result of recent American Gastroenterological Association (AGA) guideline updates, recommending use of Entyvio (or infliximab) over Humira in biologic-naive patients for induction of remission. When queried, the majority of respondents were previously aware of this news and stated that based on the information, their prescribing of Entyvio is more likely to be positively impacted than it is for infliximab. However, Spherix experts found that the negative impacts to Humira based on the guideline updates are substantially less pronounced. Takeda’s agent also appears to be gaining incremental lift from positive perceptions associated with the post-marketing VARSITY trial, which demonstrated Entyvio’s superiority to Humira in achieving clinical remission and mucosal healing in UC patients at 52 weeks.

The culmination of the above factors and timing of the updates and data releases for Entyvio could not be more appropriate, as the recent approval and launch of Janssen’s Stelara in UC is sure to make this market increasingly competitive. Even in the wake of Entyvio’s achievements, the IL-12/23 inhibitor is showing signs of a successful UC launch, a particularly impressive feat considering the current COVID-19 pandemic. Indeed, Stelara UC prescribing has held steady over the past three months, and user-base for the new market entrant has even managed to expand over the same timeframe. Aspects that may be helping to limit any damage to Stelara uptake from the pandemic include positive carry-overs from prescribers’ experiences with the product in Crohn’s disease, and virtual engagement with a Stelara sales representative.

Janssen/Stelara may also be maintaining a competitive edge over in-market rival Takeda/Entyvio regarding their level of support provided to practitioners at this time. Indeed, data collected in Spherix’s complementary Special Report series, capturing the impact of COVID-19 on specialty practices across the US, reveals that when directly asked which IBD manufacturer performs the best in reference to their level of communication/support surrounding COVID-19, rates of Janssen selection are nearly four times that of Takeda (though AbbVie leads the pack). As these biologic markets become more competitive with highly-targeted agents, manufacturer support has become a crucial aspect of any brand’s success – prior to the whirlwind of the COVID-19 pandemic – but also now more than ever.

While the future of the UC biologic/JAK market will certainly continue to evolve over the remainder of 2020, the exact changes and impacts imposed by the COVID-19 pandemic are yet to be fully realized. Nevertheless, gastroenterologists identified their intent to increase use of existing brands with alternate mechanisms of action in the near future – specifically projecting use of Entyvio, Stelara and Pfizer’s Xeljanz to significantly increase over the next six-months, largely at the expense of the more established TNF inhibitors.

Another aspect surely to impact the future of UC treatment, and more specifically use of Entyvio, is the potential approval of a subcutaneous (SC) formulation for Takeda’s agent. While the manufacturer received a complete response letter from the FDA for Entyvio SC in December 2019 (which was reportedly related to issues both with the device and with the labeling of the device), it does not appear to have deterred gastroenterologists. Indeed, the brand can expect even further expansion should the SC formulation gain approval—and while some of the adoption will come from transitioning existing Entyvio IV patients to the SC formulation, overall brand use projections are bolstered significantly further in a scenario with the additional formulation available.

As for the other half of IBD, the US Crohn’s disease market has largely remained in status quo over the past year, with minimal disruption occurring. However, one critical difference between Crohn’s and UC is the favorable status of Entyvio. While use of Takeda’s brand in Crohn’s continues to outpace that of Stelara, Entyvio does not enjoy the same advantages exemplified in the UC market. Furthermore, six-month share projections in Crohn’s reveal Stelara further closing the gap in usage between the two battling alternate mechanism brands. Entyvio will also not have the near-term luxury of expanding administration options in Crohn’s, as Takeda has reported they are prioritizing their SC submission in the US to just UC, with hopes of the Crohn’s submission to follow after – allowing Stelara to maintain the competitive edge as the only SC-administered alternate MOA treatment available.

With a robust pipeline for both UC and Crohn’s, the future of IBD treatment will likely look very different. Indeed, there are a host of unique oral agents, such as selective JAK-1 inhibitors (AbbVie’s upadacitinib, Gilead’s filgotinib), and S1P inhibitors (BMS’ ozanimod and Arena’s etrasimod), with the potential to disrupt the market with new mechanisms of action and sought-after administration.  Furthermore, there are several next generation biologics, that are working towards an arguably more targeted approach and thus improvement over the existing Entyvio and Stelara brands, including, but not limited to Roche/Genentech’s etrolizumab (MAdCAM inhibitor), AbbVie’s risankizumab (IL-23 inhibitor), Eli Lilly’s mirikizumab (IL-23 inhibitor), and Janssen’s guselkumab (IL-23 inhibitor). As each of these agents advances in development, Spherix experts anticipate dramatic change on the IBD treatment horizon.

About RealTime Dynamix™
RealTime Dynamix™: Inflammatory Bowel Disease (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Kristen Henn, Business Development Manager
Email: [email protected]
www.spherixglobalinsights.com

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