The rise of biologics within the Crohn’s disease (CD) market, starting with the anti-tumor necrosis factors (TNFs) such as AbbVie’s Humira (adalimumab), followed by the addition of anti-integrins and Janssen’s anti-interleukin (IL)-12/23 inhibitor Stelara (ustekinumab), has allowed physicians treating and managing patients’ CD to have much-needed additional therapeutic options. The next cycle in the development of biologics within the CD market is establishing the premier drug of the next generation, selective anti-IL-23 inhibitors. The outcome of this process will not only determine the top choice of this drug class but also will likely decide the CD market leader for the coming years.
The anti-IL drug class, with Janssen’s Stelara, has acquired a significant portion of the CD market share, with approximately $1.5bn of the $7.4bn in total US CD drug sales in 2022 (20.0% market share), which was second only to the $2.5bn (33.5%) of Humira, according to the recent GlobalData report, Crohn’s Disease Eight-Market Drug Forecast and Market Analysis. The jockeying of drugs within the US CD market is approaching an inflection point, with the launch of adalimumab biosimilars in 2023, and ustekinumab offerings expected in 2025. Additionally, updates to outdated treatment guidelines, which place the older Humira and other anti-TNFs before newer treatments such as Stelara, hinder its use earlier in the treatment algorithm of CD. New treatment recommendations are expected to shift first-line treatment modalities away from anti-TNFs to more recently approved therapies. These events will provide the opportunity for next-generation anti-IL-23 drugs to rise as the market leader.
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Interviews with key opinion leaders (KOLs) expressed their preference for Stelara over other therapies, and their wish to use it earlier in disease management. However, these thought leaders also expressed their belief that the selective anti-IL-23 inhibitors, made up of AbbVie’s approved Skyrizi (risankizumab), Janssen’s Tremfya (guselkumab), and Lilly’s mirikizumab (both in late-stage development), are assumed to have better profiles than Stelara, due to their selectivity. Therefore, data reflecting this belief will solidify anti-IL-23s’ place in the landscape and establish its market share.
The market positioning of the anti-IL-23s began with the release of interim data comparing Skyrizi with ustekinumab. These top-line results from the Phase III SEQUENCE (NCT04524611) trial were announced on September 12, and later presented on October 15, at the United European Gastroenterology Week (UEGW) conference. The findings showed Skyrizi matched Stelara in terms of clinical remission at Week 24, as measured by the Crohn’s Disease Activity Index (CDAI), in patients with active, moderate to severe Crohn’s disease who have failed on traditional anti-TNF agents. Skyrizi actually had a higher remission rate of 59% compared to ustekinumab’s 40%. Additionally, the data showed Skyrizi to be better than Stelara in inducing endoscopic remission, as measured by the simple endoscopic score for CD (SES-CD) at Week 48, with the former achieving 32% compared to 16% with the latter. It should also be noted that Skyrizi was shown to be significantly superior to ustekinumab in all the measured secondary endpoints.
Following AbbVie, Lilly also announced interim clinical results of the Phase III VIVID-1 (NCT03926130) mirikizumab study. As with Skyrizi, mirikizumab showed non-inferiority to ustekinumab in clinical remission at week 12; however, mirikizumab did not achieve superiority in endoscopic response measured at week 52. The fact that Skyrizi is already on the market is a significant advantage, allowing AbbVie to push the message of superiority directly to healthcare providers with little resistance. Unless Janssen’s Tremfya shows significant improvement over Stelara, comparable to or better than Skyrizi, it can be assumed that AbbVie’s Skyrizi will be the leader of the class and gain the market share that comes with the position.
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