The rise and market race of anti-IL23p19 therapies in IBD: How ECCO 2025 readouts will shape the anti-interleukin landscape
The treatment landscape of Inflammatory Bowel Disease (IBD) has undergone a significant transformation over the past two decades. Historically, therapeutic strategies primarily focused on suppressing the adaptive immune system, with monoclonal antibodies targeting tumour necrosis factor-alpha (TNF-α) leading the way. This era was marked by the approval of Johnson & Johnson’s (J&J) Remicade (infliximab) in 2005 for ulcerative colitis (UC) in the US, followed by AbbVie’s Humira (adalimumab) in 2012 and J&J’s Simponi (golimumab) in 2013. In Europe, these therapies were introduced between 2006 and 2013.
The anti-TNF era was followed by the emergence of interleukin (IL) inhibitors, with J&J’s Stelara (ustekinumab) leading the way in 2019. This therapy, initially thought to owe its efficacy to the inhibition of both IL-12 and IL-23, has since been recognised for its predominant effect on IL-23 blockade in reducing intestinal inflammation. This has given rise to a new generation of selective IL-23p19 inhibitors, a class that is rapidly reshaping IBD treatment.
This article delves into the three approved assets in this class – AbbVie’s Skyrizi (risankizumab), Eli Lilly’s Omvoh (mirikizumab), and J&J’s Tremfya (guselkumab) – and explores how ECCO 2025 readouts may further refine their positioning in the competitive interleukin-targeting space, along with discussion on the market implications of the recent entry of Stelara (ustekinumab) biosimilars in Europe.
The competitive landscape of anti-IL-23p19s at ECCO 2025
The 2025 Congress of the European Crohn's and Colitis Organisation (ECCO), taking place between 19th-22nd February 2025 in Berlin, Germany, will highlight the latest advancements in IBD treatment, with a particular focus on the anti-interleukin landscape. New data from Lilly’s Omvoh, AbbVie’s Skyrizi, and J&J’s ASTRO trial (assessing subcutaneous Tremfya at induction) will be presented.
Crohn’s disease: A race for market leadership
AbbVie’s Skyrizi holds the distinction of being the first anti-IL-23p19 therapy approved for Crohn’s disease (CD) in 2022 across the US and EU. This early entry has granted AbbVie a competitive advantage, with clinician familiarity and a strong presence in ECCO treatment guidelines. The SEQUENCE trial, which demonstrated Skyrizi’s superiority over Stelara, has further bolstered its standing in IBD treatment algorithms.
While J&J’s Tremfya awaits regulatory approval in CD following its 2024 submissions in the US and EU, Lilly’s Omvoh has already secured US approval, with a CHMP positive opinion issued in December 2024. Lilly is expected to make a strong commercial push at ECCO 2025, highlighting Omvoh’s efficacy in CD through their commercial exhibits and an industry-sponsored symposium titled: ‘Moving Into the Future: Comprehensive Management of Crohn’s Disease with IL-23p19 Inhibition’. Additionally, Lilly will present data from its Phase 3 VIVID-2 trial of Omvoh in CD, an extension study that followed patients up to Week 104. Despite initial concerns over VIVID-1’s trial design, which prevented Omvoh from showing superiority over Stelara, VIVID-2’s long-term data suggests high maintenance rates of endoscopic response (87.6%) and endoscopic remission (78.6%) – a promising sign for Omvoh’s adoption in clinical practice.
Ulcerative colitis: The Omvoh momentum and subcutaneous induction with Tremfya
In ulcerative colitis (UC), Lilly’s Omvoh has taken the lead as the first approved anti-IL-23p19 inhibitor (2023). Lilly’s emphasis on patient-reported outcomes (PROs) has differentiated Omvoh from its competitors, and the company will further its case at ECCO 2025 by unveiling results from the LUCENT-URGE Phase 3 trial.
This study explores bowel urgency (BU) – a symptom gaining recognition as a crucial UC endpoint mainly due to Lilly’s efforts in developing the Urgency Numeric Rating Scale (UNRS), which helped push BU into the American College of Gastroenterology (ACG) UC guidelines. At ECCO 2025, Lilly will present 12-week findings, that introduce novel BU assessment metrics, such as Bowel Urgency Frequency (BUF) and Stool Deferral Time (SDT), and show a more than 50% reduction in BUF among Omvoh-treated patients.
Ulcerative colitis: Subcutaneous induction with Tremfya
Meanwhile, J&J’s Tremfya has secured US approval for UC, but EU approval remains pending following its May 2024 EMA submission. Given its late market entry, J&J aims to distinguish Tremfya through a novel administration approach, offering subcutaneous (SC) induction therapy to eliminate the need for in-clinic IV infusions required for Skyrizi and Omvoh.
The ASTRO trial, whose full results will be revealed at ECCO 2025, has already demonstrated promising findings, highlighted by 65.6% clinical response vs 34.5% placebo at Week 12 and 51.3% symptomatic remission vs 20.9% placebo.
With efficacy comparable to QUASAR’s IV Tremfya induction results, regulatory approval of SC Tremfya induction seems likely, potentially setting a new standard in UC treatment convenience.
Beyond IL-23p19s: New competition on the horizon
While the anti-IL-23p19 class dominates IBD advancements, ECCO 2025 will also spotlight emerging pipeline therapies, particularly OSE Immunotherapeutics’ IL-7R antagonist, lusvertikimab (OSE127). Phase 2 CoTikiS results in UC showed 16.2% clinical remission vs 4.4% placebo and 25.0% endoscopic remission vs 12.6% placebo. Although lusvertikimab’s clinical development continues, it is unlikely to pose a direct threat to anti-IL-23p19 therapies, given their distinct immunological pathways.
Additionally, competition from Stelara biosimilars is expected to disrupt market dynamics following the 2024 European Supplementary Protection Certificate (SPC) expiry. With multiple entrants – including Stada’s Uzpruvo, Sandoz’s Pyzchiva, Celltrion’s Steqeyma, and Amgen’s Wezenla – clinicians may gravitate toward lower-cost alternatives, potentially impacting the uptake of newer branded anti-IL assets.
Looking ahead: ECCO 2025 and the future of IL-23p19 therapies
With the recent approvals of all three major anti-IL-23p19 assets in at least one of the IBD indications, ECCO 2025 will provide critical insights into their future market trajectories. The key strategic focuses of each company will be:
- AbbVie’s Skyrizi: Leveraging its first-to-market advantage and 96-week COMMAND OLE data
- Lilly’s Omvoh: Positioning itself as the leader with patient-reported outcomes
- J&J’s Tremfya: Differentiating through subcutaneous induction for greater patient convenience
Beyond IL-23p19s, TL1A inhibitors are emerging as a major new class in IBD, with Phase 2 RELIEVE UCCD results from Sanofi/Teva’s duvakitug expected to spark discussions about potential future of this mechanism of action in IBD.
As ECCO 2025 unfolds, all eyes will be on how these new data sets will further shape the evolving IBD treatment paradigm.
About the authors
Gaja Gasiorek is a senior business analyst at Lifescience Dynamics, specialising in immunology with a particular focus on inflammatory bowel disease (IBD). She has over three years of experience in this field, bringing expertise in market research, competitive intelligence, and strategic analysis. Prior to joining Lifescience Dynamics, Gasiorek worked at a market research firm specialising in competitive intelligence and held various roles in diagnostics-focused start-ups, where she contributed to market access, operations, and business development. She holds a BSc in Biotechnology, where she conducted research on gene-editing technologies, including CRISPR-Cas9. Additionally, she earned an MPhil in Bioscience Enterprise from the University of Cambridge, where she gained in-depth knowledge of drug discovery, development, and the pharmaceutical industry's strategic landscape from leading industry experts.
Pooja Goyal is a senior consultant based out of Lifescience Dynamics’ Toronto office. She has over nine years of experience in the pharmaceutical consulting industry. Goyal brings expertise in competitive intelligence, opportunity assessment, market access and pricing, and disease area strategy projects in immunology and other therapy areas. During the early part of career, she also worked in the analytical R&D of a leading ophthalmic manufacturing firm. Goyal holds an MS (Pharm) in Medicinal Chemistry from the National Institute of Pharmaceutical Education and Research (NIPER), Mohali, India and a Bachelor’s in Pharmaceutical Science from Panjab University, Chandigarh, India.
