US Gastroenterologists Report VARSITY Trial Data and JAK Inhibitor Safety Concerns Will Impact Their Prescribing Behavior in Ulcerative Colitis, with Potential Implications for Crohn's Treatment

EXTON, Pa., June 5, 2019 /PRNewswire/ -- While both the ulcerative colitis (UC) and Crohn's disease markets have remained relatively stable since the prior quarter in terms of brand share and user base, Spherix captured reactions to recent key market events that could begin to ripple through the landscape (particularly in UC). According to the latest wave of RealTime Dynamix™: Inflammatory Bowel Disease (US), a study which analyzed the responses of 95 US gastroenterologists, results from the Phase 3b VARSITY clinical trial comparing Takeda's Entyvio and AbbVie's Humira are proving to have an actual impact on respondents' perceptions and prescribing of the two key brands.

Data from the VARSITY trial indicated that among moderate-to-severe, active UC patients, Entyvio was superior to Humira regarding the percent of patients achieving clinical remission and mucosal healing after 52 weeks of treatment. According to Spherix's Q2 study, the majority of respondents report the VARSITY data will have a strong, positive impact on their UC prescribing of Entyvio, while a smaller group feel there will be a negative impact on their use of Humira. In addition, current Entyvio UC brand share is significantly higher and Humira UC brand share is significantly lower when looking at gastroenterologists who were aware of the VARSITY trial compared to those who were not aware at the time of fielding – the same holds true when looking at future share projections. To further the point, most respondents agree that Entyvio is more efficacious than Humira based on the VARSITY data, and that the data will lead them to prescribe more of the former over the latter.

Gastroenterologists, however, are split on whether this aura of superiority will carry over into the treatment of Crohn's, as respondents are divided in agreement on, "while the VARSITY data indicated Entyvio's superiority over Humira in UC, Humira is a much stronger option for the treatment of Crohn's." Furthermore, current Crohn's brand share for Entyvio and Humira changes little with awareness of the trial outcomes. Spherix did find that there is indeed a small, but significant difference in future share projections according to awareness, suggesting there may be a slow-creeping impact of this UC trial data on gastroenterologists' prescribing behavior in Crohn's.

While the VARSITY data may not negatively impact perceptions of Humira prescribing in Crohn's initially, there is evidence that it may translate into perceptions of inferiority for all TNF inhibitors. In fact, a sizeable percent of respondents agreed that since Entyvio demonstrated superiority over Humira with respect to achievement of clinical remission and mucosal healing, it is likely superior to other TNF inhibitors, including infliximab. Takeda's recent announcement of the FDA acceptance of the Biologic License Application for the subcutaneous (SC) formulation of Entyvio in UC may help boost the brand over TNF inhibitors, though there is some controversy among surveyed gastroenterologists on whether agents with dual administrations have an advantage over those with just one modality. When probed about the importance of new product characteristics for agents in development, availability of both IV and SC dosing forms was the second-to-last most desired trait.

Interestingly, when comparing Entyvio and Janssen's Stelara for the treatment of Crohn's, the latter was reported as performing substantially better in terms of overall efficacy, induction of remission, sustained remission, and mucosal healing. Even though Entyvio enjoys a slightly higher brand share and recent prescription share than Stelara in Crohn's, the metrics that Stelara outperforms Entyvio on are the same ones Takeda's brand was proven to outperform Humira on in the VARSITY trial. What implications will this have for Stelara if and when approved for the treatment of UC? Spherix data suggests the concern will no longer be whether novel, alternate mechanism of action agents can shake the TNF-dominant market, but which of the newer competitors is going to cause the biggest stir.

Another event that has already begun to impact the UC market is the controversial issue of JAK inhibitor safety concerns. In late February, Pfizer announced preliminary results of an ongoing post-marketing requirement study for Xeljanz, revealing that rheumatoid arthritis (RA) patients aged 50 or older receiving Xeljanz 10mg BID were statistically more likely to experience pulmonary embolism than those treated with a TNF inhibitor. Additionally, those on the 10mg twice daily dose were also at an increased risk of overall mortality than those treated with a 5mg BID dose or those on a TNF inhibitor. Prior to being prompted about Pfizer's news release regarding the increased risk of venous thromboembolic events (VTE) and overall mortality among trial RA patients, this news appears to have already impacted gastroenterologists' perceptions of Xeljanz negatively. Concerns about serious adverse events and long-term safety—both of which have been stable since the brand's launch—have skyrocketed as barriers for increased prescribing in the current wave. Indeed, while concern with various side effects of Xeljanz (herpes zoster, serious infections, etc.) have remained stable quarter over quarter, the percent of respondents that are extremely concerned about the potential for the development of VTEs has nearly doubled since Q1 2019.

Furthermore, the percent of gastroenterologists who believe Xeljanz is a substantial advance over other available UC therapies has sharply dropped, while the percent of respondents who believe Xeljanz now falls "below their initial expectations" has more than doubled over the past quarter. Of particular note is that among UC patients currently treated with Xeljanz, over sixty percent are on a 10mg BID dosing regimen (mostly still in induction but nearly one in five have continued the dose after the suggested eight-week induction period.) When prompted, over half of respondents were already aware of the news regarding Xeljanz's safety among RA patients, and the majority report there could be significant impacts to their use of the brand. Indeed, the bulk of gastroenterologists report that the news influences their opinion on Xeljanz's safety and the vast majority also claim it will have an effect on their willingness to prescribe the brand. Moreover, and of potentially the most interest, over half of respondents report that the adverse cardiovascular events are likely a class effect of JAK inhibitors, and are not limited to just Xeljanz – an aspect that companies with JAK inhibitors in the pipeline (AbbVie's upadacitinib and Gilead/Galapagos' filgotinib) should be closely monitoring.

About RealTime Dynamix™
RealTime Dynamix™: Inflammatory Bowel Disease (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include IBD market trending, launch tracking, and a fresh infusion of unique content with each wave. A companion service, RealTime Dynamix™: Inflammatory Bowel Disease (EU), tracks the evolution of the IBD market in the EU5 countries through a twice-yearly report series.

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 immunology, nephrology, and neurology markets.

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

For more information contact:
Lynn Price, Immunology Franchise Head
Email: info@spherixglobalinsights.com
www.spherixglobalinsights.com

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