Takeda's Entyvio and Janssen's Stelara Share of Inflammatory Bowel Disease Biologic-Naive Patients Continues to Increase as This Patient Group Expands Their Involvement in the Decision-Making Process

EXTON, Pa., July 30, 2020 /PRNewswire/ -- The 2020 audit included in Spherix's RealWorld Dynamix™: Biologic/Small Molecule New Starts in IBD (US) service focuses on a key bellwether of the ulcerative colitis and Crohn's disease markets – the newly initiated patient. Despite the entry of only one new brand to treat IBD over the past two years (with Pfizer's Xeljanz 2018 FDA approval in UC) and a few product label expansions, the treatment of biologic-naïve patients continues to evolve as physician and patient preferences change. Specifically, alternative mechanism of action agents (AMOAs) are growing in share, as anti-TNF therapies slowly decline in use.

AMOAs, such as Takeda's Entyvio, Janssen's Stelara, and Pfizer's Xeljanz, collectively represent one-third of the currently treated, first-time biologic/small molecule IBD patients. Further, when asked which type of biologic therapy gastroenterologists would prescribe next, more than fifty percent of patients would be prescribed one of these AMOAs. AbbVie's Humira is most negatively impacted by the transition away from the anti-TNFs and is predicted to lose more than half of its share of this patient group if first-line treatment is ultimately deemed unsuccessful and a switch takes place.

The most recent market entrant in UC, Stelara, has managed to capture a significant amount of new start share since the FDA approval of its label expansion last year. Efficacy performance was the primary driver for that growth in UC, though the drug's mechanism of action played a pivotal role as well. While the Spherix study focuses on biologic-naïve patients, the survey also asks about potential next steps for these patients. Indicating an even greater opportunity for the IL-12/23 inhibitor in the second- and third-line settings. Contrary to Humira, Stelara is predicted to more than double its share in the second-line patient segment should the first-line treatment turn out unsuccessful. Stelara's outperformance in UC is also likely a factor of the company's selection as the manufacturer most committed to research and development in IBD, the only category where a company other than AbbVie was selected in the top spot.

Despite Stelara's first-year success in UC among biologic-naïve patients, the brand still faces a threat from the most prescribed AMOA in UC, Entyvio. In almost half of the new patients receiving Stelara, if Stelara was not available, Entyvio would have been prescribed instead. Takeda's agent has also experienced growth of its own, as the product's audited share of newly-treated UC patients increased by nine absolute share points versus last year.

Unlike Stelara, where first-line use was relatively flat, Entyvio's share of Crohn's disease patients versus last year increased as well. Entyvio's specific MOA and safety profile are the two primary drivers for the brand's success over the past year. However, Entyvio also has some perceived efficacy strengths; the product had the highest selection of mucosal healing as a reason for selection in the treatment of UC.

The latest IBD study from Spherix also documents the challenges in managing the treatment of UC and Crohn's patients. The patients captured in the audit, with an average age of 38, are engaged in many activities, including a majority who work full time. Approximately forty percent of the patient records are documented by gastroenterologists as having a "very active lifestyle." Yet, despite this vitality, roughly one-third or more of patients suffer moderate to severe impairment in work, school, social, leisure and family activities related to their IBD.

Perhaps related to patient unmet needs, the report identifies increased patient involvement in treatment decision-making. Specifically, the percentage of patients who were either the driver of the biologic-naïve therapy decision or had significant input into the process increased significantly over 2019 reports. Physicians also acknowledged that in many of those patients, there was a strong clinical rationale for the patient's role in the decision-making process. This also represented a significant jump in that category versus last year.

Despite the increasing role of patients in treatment plans, for most brands, one-third or more of patients were resigned or anxious about initiating biologic therapy for their IBD. The exception was the oral therapy, Xeljanz, where one-half of the patients were identified as excited/motivated, despite the implementation of a black box warning by the FDA last year. This result underscored the importance of mode of administration on the treatment decision process in UC and Crohn's. Indeed, patients who had received a subcutaneous (SC) or oral formulation were twice as likely to select mode of administration as a driver for the decision process than patients receiving an intravenous (IV) formulation. Likewise, these oral/SC patients are twice as likely to be selected as the primary driver in the decision-making process than patients receiving an IV formulation.

Scanning to the future of the market, the 2020 audit identifies that Entyvio is poised to capitalize on increased patient involvement in the decision process with its SC formulation. While still pending FDA approval, Entyvio SC has a significant advantage over other current pipeline agents in terms of familiarity and preference. More than one-half of gastroenterologists rate themselves as extremely familiar with Entyvio SC for UC and Crohn's. Nearly one-half of physicians also selected Entyvio SC as their preferred developmental agent for the treatment of IBD.

When examining the first-line charts, Entyvio SC is most likely to cannibalize share from Entyvio IV, but it is also likely to capture share from several other market competitors. Despite this significant opportunity for Entyvio SC success, these bright prospects may go unrealized if the therapy cannot garner approval by the FDA. Entyvio SC received a complete response letter from the FDA in late 2019, but Takeda reports that they are in ongoing discussions with the agency and project a resubmission for the subcutaneous formulation by the end of 2020.

Novel agents in development also possess opportunity for adoption for the treatment of IBD, specifically oral therapies currently in the pipeline. Gilead/Galapagos' filgotinib and BMS' ozanimod are the two oral therapies in development for IBD that stand to gain the most should they become commercially available. Filgotinib and ozanimod are also the most familiar therapies in development to gastroenterologists, behind Entyvio SC. Roughly one-quarter of physicians selected these two treatments as their preferred therapy in development. Finally, gastroenterologists are aware of the opportunity that oral therapies represent to their patients, which (as mentioned above) are predominantly young with active lifestyles and would greatly benefit and likely prefer an orally administered product. In fact, the most agreed-upon attitudinal statement in the study involved patient preference for oral therapies over those that are injected or infused.

About RealWorld Dynamix™
RealWorld Dynamix™: Biologic/Small Molecule New Starts in IBD (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

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

SOURCE Spherix Global Insights

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