Recent, Positive Efficacy Data for Janssen’s Stelara in Refractory Crohn’s Disease Significantly Boost Patient Share for the IL-12/23 Inhibitor,…

EXTON, Pa., Sept. 9, 2020 /PRNewswire/ --According to the latest report published as part of Spherix'sRealTime Dynamix: Inflammatory Bowel Disease USservice, gastroenterologists (n=100) continue to report increases in their prescribing of alternative mechanism of action (AMOA) agents, such as Janssen's Stelara and Takeda's Entyvio, for ulcerative colitis (UC) and Crohn's disease (CD). The AMOA therapies have collectively increased their share of the CD biologic/small molecule market by four percent in the past year, while the TNF inhibitor class has fallen by the same amount. In UC, the transition has been even more dynamic, as the AMOA therapies have increased their share by ten percent in the past year, while TNF therapies have decreased to an identical extent.

The driver of Stelara's three percent share increase in CD over the past quarter alone is likely attributable to new efficacy data versus Entyvio. Since the beginning of the year, there have been at least three articles written that address clinical data for Stelara's efficacy in refractory CD patients.Twoof the articlesspecifically cover Stelara's stronger efficacy in TNF-refractory CD patients when compared to Entyvio. The third articlepresents long-term, real world effectiveness data for Stelara in refractory CD patients from the ENEIDA registry. Together, these data and articles appear to have triggered a boost in Stelara's efficacy perceptions in CD among gastroenterologists.

The most recent results for Stelara follow a path that Entyvio charted in UC last year after the release of the VARSITYhead-to-head study versus AbbVie's Humira. In March 2019, Takeda announced higher clinical remission rates for Entyvio in UC patients compared to the blockbuster TNF inhibitor. The impact of that study on Entyvio prescribing in UC has led to a five percent share increase for the therapy in the disease state compared to the same time last year.

The results for both Stelara and Entyvio also highlight the importance that efficacy plays in the physician therapy decision-making process for biologics in CD and UC. Effectively illustrating this point, the RealTime Dynamix report also includes an analysis of stated and derived drivers in treating CD and UC patients. For both diseases, efficacy attributes like mucosal healing, sustained remission, and induction of remission are stated by gastroenterologists to be the most important factors in deciding on an advanced therapy for CD and UC.

The derived drivers analysis, which correlates how an agent performs on specific attributes with the overall performance rating for that therapy, has strong, consistent agreement with the stated importance results. The outcome of this analysis shows that significant improvements in the efficacy ratings (e.g. mucosal healing, sustained remission, and induction of remission) lead to the biggest increases in perceived overall product performance for biologics in both CD and UC.

Translating how the importance of these attributes results in advantages for specific brands is critical. In the case of CD, Stelara's ratings for mucosal healing, sustained remission, and induction of remission placed the therapy in either first or second place in overall performance, out of all of the brands assessed. For Stelara, this translated into a tie for the top spot in overall performance in CD, but more importantly, it has aided in the three-point share increase in CD for the most recent quarter. Similarly, a year after the VARSITY data were released, Entyvio's perceived performance for mucosal healing, sustained remission, and induction of remission superseded other available brands for UC. Not only did these results lead to Entyvio attaining the highest overall score among UC therapies, but they contributed to the corresponding growth in Entyvio prescribing that has occurred over the past year.

The fifth annual switching and third annual new start audits included in Spherix's RealWorld Dynamix service takes the derived analysis to another level with a thorough review of the dynamics involved in treating CD and UC patients who were recently switched between or initiated on biologic/small molecule therapies.

Recently, there has been a spate of clinical data and FDA decisions with potentially negative consequences for IBD therapies in clinical development. Just last month, Phase 3 datafor Roche/Genentech's etrolizumab showed the agent missing its primary endpoint in UC. Etrolizumab is a second-generation CAM being developed for UC and CD with a subcutaneous form of administration. While the manufacturer has indicated it will conduct further analyses of the data, next steps for the therapy in CD and UC are unclear at this point.

Likewise, filgotinib, an oral JAK1 inhibitor being developed for UC and CD by Gilead/Galapagos, received a complete response letter(CRL) to its application for approval in rheumatoid arthritis. The CRL was generated based on concerns about the risk/benefit profile of the medication. Filgotinib is also in development for CD and UC, and the FDA response is likely to delay the clinical development of the therapy in these IBD indications.

Despite these setbacks in IBD development, there are several other therapies that continue to progress toward a potential indication in the next year or two. One such therapy is ozanimod, an oral sphingosine-1-phosphate receptor (S1P) being developed for UC and CD by BMS. Phase 3 datawere released for ozanimod showing clear benefit to UC patients. Gastroenterologists appear to have already noticed these results, as ozanimod is now the second most familiar and preferred IBD therapy in development behind Takeda's Entyvio SC. Spherix will continue to monitor and analyze the impact of clinical and regulatory events, along with the successes in clinical outcomes, for CD and UC therapies that are currently in development.

AboutRealTime Dynamix RealTime Dynamix: Inflammatory Bowel Disease USis 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 InsightsSpherix 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:[emailprotected] http://www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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Recent, Positive Efficacy Data for Janssen's Stelara in Refractory Crohn's Disease Significantly Boost Patient Share for the IL-12/23 Inhibitor,...