EXTON, Pa., Sept. 24, 2020 /PRNewswire/ — The 2020 audit included in Spherix’s RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (US) service focuses on a critical facet of overall biologic and JAK therapy prescribing for ulcerative colitis (UC) and Crohn’s disease (CD) patients – advanced therapy switching. The study captures the myriad of data surrounding the process by which inflammatory bowel disease (IBD) patients are switched from one advanced therapy to another and corroborates Spherix’s physician-reported data on the downward trend of branded TNF inhibitor use (namely AbbVie’s Humira and Janssen’s Remicade) due to the continued uptake of alternate mechanism of action (AMOA) agents, such as Takeda’s Entyvio and Janssen’s own Stelara.
In both UC and CD, Humira and infliximab (Remicade and its biosimilars) still hold the largest patient share in the first-line setting. It is only in examining the switch dynamic, does the opportunity for AMOAs become fully evident. In UC, the patient records indicate that Humira’s share by line of therapy is reduced by two-thirds in the progression from the first- to third-line setting, while infliximab’s share is reduced by one-half from just first to second line. In contrast, Entyvio share in UC triples in the progression from first line to second line, while Stelara’s share increases three-fold from just second to third line. Pfizer’s Xeljanz experiences an almost five-fold increase in UC share in the progression from first-line to third-line UC therapy. Similar patterns were found when examining the change in share by line of therapy for the TNFs and AMOAs indicated in CD.
In measuring the reasons for needing to switch IBD patients in the first place, the audited records identify that efficacy, in different forms, is the primary driver of the current switch patterns. Primary efficacy failure, secondary efficacy failure, and lack of full clinical remission are the top three factors selected by physicians, regardless of the therapy they are switching from in both UC and CD. This indicates that failure in primary clinical endpoints, secondary clinical endpoints, and patient remission all play a role in the decision to switch an IBD patient from one biologic/JAK therapy to another. However, Entyvio and Stelara both provide evidence that they can address those efficacy needs with the VARSITY study results in UC from last year and with more recent clinical data for Stelara among TNF refractory patients in CD.
First for Entyvio, the favorable efficacy perceptions relative to Humira from the VARSITY study resulted in the therapy being selected most often in UC switches to address the «primary efficacy failure» of the original first-line therapy. Entyvio also had the most common selection in terms of addressing the lack of «full clinical remission» with the original first-line therapy. Likewise, Stelara’s recent, favorable data released relative to Entyvio in TNF-refractory CD patients led to the IL-12/23 inhibitor being the most common selection in terms of addressing the primary efficacy failure of the original first-line therapy. Further evidence of Stelara’s perceived advantages in CD is apparent, as the brand captured the highest percentage of mild, severe, and active flare CD patients at their most recent switch.
Physicians who started IBD patients on first-line TNF therapy were not the only prescribers open to a different mechanism of action when needed. The audit results also indicate that, in the less common situation when AMOAs, such as Entyvio and Stelara, are prescribed first-line in UC and CD, a TNF therapy is much more likely to be prescribed next if that AMOA therapy fails. Anecdotally, the study also captured high gastroenterologist agreement with the statement «after a first-line primary TNF-failure in IBD, I usually move to a biologic with a different MOA.» Thus, the overall switch to AMOAs in second-line in IBD is part of an even broader continual search for optimal efficacy when a mechanism of action cannot address that need as a first-line or even second-line therapy.
While Entyvio and Stelara are leading the switch-to AMOAs in IBD, switching patterns for the JAK-1 inhibitor, Xeljanz, are also intriguing. Xeljanz UC prescribing was highest in the third-line setting. Audit records indicate that Xeljanz is second among current UC therapies (behind Entyvio) in the percentage of patients who are switched due to primary and secondary efficacy failure in the prior therapy and second (behind Stelara) in patients with active flares. Furthermore, Pfizer’s JAK has the lowest percentage of IBD patients with concomitant treatment from conventional therapies. Collectively, these data and the overall prescribing patterns for Xeljanz likely reflects physician trial of different mechanisms as patients are unable to obtain the necessary level of efficacy from the prior two lines of therapy. Unfortunately, this pattern of prescribing also led to Xeljanz having the highest percentage of UC patients switching away from it due to its «efficacy profile.»
Therapies in development may rely heavily on IBD patient switching when they are eventually launched on the IBD market. The pipeline agent most able to capitalize on that potential opportunity is Entyvio SC. When asked which pipeline agent they would have used in place of their current UC and CD therapies, gastroenterologists selected Entyvio SC, more than any of the other listed therapies in development, as a replacement for Entyvio, Humira, Remicade, Stelara, and Xeljanz. While respondents anticipate Entyvio SC to cannibalize the IV formulation of Entyvio, other therapies could also be «at risk» if Entyvio SC is approved and launched.
When asked whether Entyvio SC would have been prescribed instead of the current switch-to UC therapy, 78% of the current Entyvio IV records indicated «yes,» while around half of the Humira and Stelara records were also in the affirmative. Likewise, when asked whether Entyvio SC would have been prescribed instead of the actual CD therapy, 70% of the current Entyvio IV records indicated «yes», while around half of the Humira records were also positive. Ozanimod, an oral sphingosine-1-phosphate receptor (S1P) being developed by BMS, is another «therapy to watch» in IBD as it received the second highest candidate scores for both UC and CD, behind Entyvio SC.
About RealWorld Dynamix™
RealWorld Dynamix™: Biologic/Small Molecule Switching 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.
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