According to a recent report by Spherix Global Insights, US gastroenterologists’ (n=99) adoption of Xeljanz for the treatment of ulcerative colitis continues to be positive, but looming safety concerns could spell trouble for the first-in-class JAK inhibitor.

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EXTON, Pa., March. 26, 2019 /PRNewswire/ — At approximately eight months post-launch, Pfizer’s Xeljanz is continuing to have success penetrating the US ulcerative colitis (UC) market, according to Spherix Global Insights’ quarter one update of RealTime Dynamix™: Inflammatory Bowel Disease (US).  While the recent growth of Xeljanz is largely sourced by an expanding user base (as opposed to patient base), and as familiarity and use of the brand grows, respondents are increasingly likely to believe that Xeljanz has exceeded their initial expectations – suggesting current positive experiences among prescribers. Furthermore, though the majority of Xeljanz UC patients have already been exposed to biologics, users report that approximately one-fifth are treated first-line/in the pre-biologic setting, a highly desired position in this increasingly competitive market.

Despite that fact that Humira is the highest frequently cited brand most at risk for displacement from increased Xeljanz adoption, over half of the most recent Xeljanz prescriptions would have been placed on Entyvio had Xeljanz not been available. Furthermore, current Xeljanz users are over four times more likely than non-users to select Entyvio as the agent Xeljanz will most likely replace. Indeed, last five prescription share as well as projected six month share for Xeljanz reveal substantial growth for Pfizer’s JAK for the treatment of UC in 2019.  This growth will largely come at the expense of the established TNF inhibitors, Humira and Janssen’s Remicade, though six-month share projections also reveal a flattening of Entyvio.

While Pfizer’s JAK is off to a good start, the picture isn’t all rosy. Participating gastroenterologists report that formulary coverage, concerns about safety/adverse events, and a lack of familiarity are the greatest barriers holding them back from prescribing more Xeljanz. Moreover, one-third report extreme concern about the risk of herpes zoster, and while only one-fifth are currently highly concerned about the risk of deep vein thrombosis, this figure will likely grow in the future as gastroenterologists learn about recent data reported by Pfizer regarding heightened cardiovascular (CV) risk in rheumatoid arthritis (RA) patients. Specifically, last month, just after fielding of this study, Pfizer announced preliminary results of an ongoing, FDA required, post-marketing study investigating the risk of CV events for RA patients over the age of 50 taking 10mgs of Xeljanz twice daily. Findings indicated that RA patients on the 10mg BID dose of Pfizer’s JAK were statistically more likely to experience pulmonary embolism than those treated with a TNF inhibitor. Additionally, those on the 10mg twice daily dose of Xeljanz were also at an increased risk of overall mortality than those treated with a 5mg BID dose of Xeljanz or those on a TNF inhibitor.1 While the 10mg BID dose is currently not FDA approved in RA, it is in UC, and patients are recommended to take the 10mg BID dose for at least the first eight weeks of treatment. Indeed, users report that over two-thirds of their Xeljanz UC patients are currently on a 10mg BID dose, the exact one delivering significant heightened CV risk in RA, likely spelling future trouble among this group of practitioners, who already express concerns about the JAK’s safety and serious adverse events.

Another aspect that could have an impact on the UC advanced systemic market is Takeda’s recently reported results from a phase 3b study which compared Entyvio and Humira in a head-to-head trial. Data from the trial indicated that among moderate-to-severe, active UC patients, Entyvio was superior to Humira with regards to the percent of patients achieving clinical remission and mucosal healing after 52 weeks of treatment. 2  When Spherix survey respondents were queried about which advanced systemic therapies for the treatment of UC they would choose if limited to just two, nearly 70% selected a combination including Entyvio, while only 44% selected a combination including Humira.  However, in prior research conducted by Spherix, Humira was selected as the preferred agent for UC patients with mucosal lesions two-to-one over Entyvio, an affliction estimated to affect nearly 40% of the biologic/JAK-treated or eligible UC population.

While the US Crohn’s market has undergone less turbulent change, gastroenterologists report that the biologics with alternate mechanisms of action (MOA), Stelara and Entyvio, will likely reap the benefits of decreased use of Humira and Remicade. Specifically, recent Spherix analysis of the last five recent Crohn’s prescriptions, as well as projected six-month brand allocations, reveals that use of the leading TNFs are on the decline, in favor of significant growth for both Stelara and Entyvio.

With a flurry of investigational agents in development for both Crohn’s and UC, gastroenterologists report that they most desire an agent in development that not only achieves, but maintains remission, has evidence of mucosal and histologic healing, and is well tolerated among patients. While overall pipeline familiarity is low, Celgene’s investigational oral S1P1, ozanimod, was selected with the greatest frequency as a top agent that respondents would most like to gain FDA approval, and selection was commonly attributed to the unique MOA, oral administration, and attractive safety profile. Ozanimod is not the only orally administered agent being developed for the treatment of IBD, with AbbVie’s upadacitinib, Gilead/Galapagos’ filgotinib, and Arena’s etrasimod, among others, each looking to claim their stake in the IBD frontier. Spherix Global Insights will continue to track this ever-evolving market on a quarterly basis in the US, and bi-annually across the EU5.

About RealTime Dynamix™
RealTime Dynamix™: Inflammatory Bowel Disease (US) is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. The next wave of the study will field in June 2019 and will continue to track emerging trends, with a focus on the Xeljanz launch in UC. A companion report series, RealTime Dynamix™: Inflammatory Bowel Disease (EU), tracks the evolution of the IBD market in the EU5 countries on a bi-annual basis and will field next in Q2 2019.

About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

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: [email protected]
www.spherixglobalinsights.com

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1. https://investors.pfizer.com/investor-news/press-release-details/2019/
2. https://www.takeda.com/newsroom/newsreleases/2018/entyvio-shows-higher-rates-of-mucosal-healing-versus-tnf-antagonist-therapy-in-real-world-data-analysis/