Exton, Pennsylvania, Nov. 30, 2023 (GLOBE NEWSWIRE) -- With the Ulcerative Colitis (UC) market set to heat up in the coming months, the JAK class seems poised to become a dominant treatment, challenging established alternative mechanism of action (AMOA) favorites: Takeda’s Entyvio (vedolizumab) and Johnson & Johnson Innovative Medicine/Janssen’s Stelara (ustekinumab).
Over the past two months, the landscape of UC treatment has undergone a significant expansion, introducing four new options. Among them is Eli Lilly’s Omvoh (mirikizumab), marking the pioneering entry of an IL-23 inhibitor to UC, Pfizer’s Velsipity (etrasimod) joins as a second Sphingosine-1 phosphate (S1P) receptor-modulator, complemented by two subcutaneous (SC) formulations of esteemed choices for physicians—Entyvio (vedolizumab) and infliximab (Celltrion's SC infliximab, Zymfentra). These newcomers step into an already bustling market, teeming with both branded and burgeoning biosimilar alternatives.
The first line of UC treatment remains overwhelmingly dominated by the firmly established anti-TNF therapies (such as Humira and Remicade) alongside Entyvio. This stronghold has created a scenario where additional contenders primarily vie for position as the first alternative after a patient experiences failure with either of these options.
The first S1P entrant, BMS’s Zeposia (ozanimod), has attempted to establish a strategic position in the pre-biologic space, but has encountered challenges in gaining substantial momentum. Furthermore, the favored choice among physicians in Crohn’s disease (CD), Stelara, has continued to enjoy a position in later-line UC treatment.
Analysis by Spherix reveals physicians stated prescribing of the JAK class of treatments, first seen with Pfizer’s Xeljanz (tofacitinib), has more than doubled across all lines of therapy over the past year (RealTime Dynamix™: UC, US, Q3 2023). A significant portion of the lift can be attributed to the addition of AbbVie’s Rinvoq (upadacitinib), which physicians report prescribing largely in second and later line patients. This later line use is consistent with the JAK prescribing labeling, which includes a black box warning requiring doctors attempt treatment with at least one biologic before prescribing the oral class. In fact, US physician stated use of JAKs in first line is less than five percent.
The intrigue deepens when examining physician actual prescribing via patient records. Indeed, a Spherix audit of US UC patient charts reveals that physicians are employing JAKs in the first line setting at a rate exceeding three times their initially stated usage (Patient Chart Dynamix™: IBD New Starts, US, 2023). Furthermore, the number of times physicians consider using JAKs in the first line setting could expand the JAK treated patients substantially.
Add to this, physician use of JAKs in later line, shows that only Entyvio is used more often as a second line agent, and JAKs exceed all other agents in third and later line treatment (Patient Chart Dynamix™: IBD Switches, US, 2023).
What is driving this interest in JAKs? An obvious answer might be their oral formulation, shared only with Zeposia and now Velsipity. However, as noted above, Zeposia has not enjoyed the same adoption as JAKs in its two-year push into the UC market. What is more likely the driver for JAKs is Rinvoq’s strong efficacy profile. In the absence of head-to-head clinical trial data for Rinvoq, the drug boasts some of the more numerically impressive response and remission rates for treating UC. In fact, Spherix benchmarking with physicians shows Rinvoq clinical response and sustained remission very nearly achieves their expectations for clinically compelling future therapies (RealTime Dynamix™: UC, US, Q2 2023).
It remains to be seen how the latest entrants, namely Omvoh and Velsipity, will upset this emerging dynamic. Pfizer’s added marketing muscle in the pre-biologic space hold the potential to firmly establish S1Ps as a safer and preferable oral alternative to JAKs, particularly for patients wanting to avoid injections, as the S1Ps do not carry a similar boxed warning. Omvoh’s IL-23 MOA is a favorite among gastroenterologists who already have experience with the class in CD via AbbVie’s Skyrizi (risankizumab). Further, IL-23’s are widely regarded as the next evolutionary step beyond the IL-12/23 class pioneered by Stelara. Both these novel agents possess the capability to challenge JAKs and other existing therapies across initial and subsequent lines of therapy. Spherix will be tracking the launch of Omvoh, Velsipity, and the subcutaneous formulation of Entyvio beginning in December of this year.
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
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