The treatment landscape for Inflammatory Bowel Disease (IBD) continues its dramatic evolution with the emergence of selective IL-23p19 inhibitors, marking a significant advancement from traditional anti-TNF therapies. This new class of biologics is rapidly becoming a cornerstone in IBD management, offering improved targeting of inflammatory pathways.
AbbVie's Skyrizi (risankizumab) established itself as the pioneer in Crohn's disease, securing approvals in both the US and EU in 2022. The therapy's superiority over Stelara, demonstrated in the SEQUENCE trial, has solidified its position in treatment algorithms and clinical guidelines.
Eli Lilly's Omvoh (mirikizumab) has gained momentum, particularly in ulcerative colitis, where it became the first approved anti-IL23p19 inhibitor in 2023. The upcoming ECCO 2025 congress will feature results from the VIVID-2 trial, showcasing impressive 104-week data with maintenance rates of 87.6% for endoscopic response and 78.6% for endoscopic remission in Crohn's disease.
Innovation in Clinical Endpoints and Administration
Lilly has pioneered new approaches to measuring treatment success, particularly in ulcerative colitis. The company's development of the Urgency Numeric Rating Scale (UNRS) has led to the inclusion of bowel urgency as a crucial endpoint in ACG guidelines. The LUCENT-URGE Phase 3 trial results, to be presented at ECCO 2025, will introduce novel metrics including Bowel Urgency Frequency and Stool Deferral Time, with preliminary data showing over 50% reduction in urgency frequency among Omvoh-treated patients.
J&J's Tremfya (guselkumab) is pursuing a unique strategy with its subcutaneous induction therapy for ulcerative colitis. The ASTRO trial results, slated for full presentation at ECCO 2025, have demonstrated promising outcomes with 65.6% clinical response versus 34.5% for placebo at Week 12. This administration route could eliminate the need for in-clinic IV infusions, potentially offering significant advantages in treatment convenience.
Market Dynamics and Future Perspectives
The competitive landscape is further complicated by the recent entry of Stelara (ustekinumab) biosimilars in Europe, including Stada's Uzpruvo, Sandoz's Pyzchiva, Celltrion's Steqeyma, and Amgen's Wezenla. This development may influence physician prescribing patterns and impact the adoption of newer branded therapies.
Beyond IL-23p19 inhibitors, emerging therapies are showing promise. OSE Immunotherapeutics' lusvertikimab, an IL-7R antagonist, has demonstrated encouraging Phase 2 results in ulcerative colitis, with 16.2% clinical remission compared to 4.4% for placebo. Additionally, TL1A inhibitors are gaining attention, with anticipated Phase 2 RELIEVE UCCD results from Sanofi/Teva's duvakitug expected to generate significant interest.
Strategic Positioning at ECCO 2025
The upcoming ECCO congress will be crucial in defining the future trajectory of these therapies. AbbVie aims to leverage Skyrizi's first-mover advantage in Crohn's disease, while Lilly positions Omvoh as a leader in patient-reported outcomes. J&J's focus remains on differentiating Tremfya through its innovative subcutaneous administration approach.
As the IBD treatment paradigm continues to evolve, the integration of these new therapies and emerging data will be critical in shaping clinical decision-making and improving patient outcomes. The competition among anti-IL23p19 therapies, combined with the entry of biosimilars and novel therapeutic approaches, promises to provide physicians with an expanded arsenal of treatment options for IBD patients.
