In recent developments, a drug already approved by the U.S. Food and Drug Administration (FDA) for ulcerative colitis is showing promise in treating Crohn’s disease as well. The pharmaceutical giant, Eli Lilly, has unveiled promising data from two pivotal studies, indicating that mirikizumab might be a game-changer for those grappling with these chronic inflammatory bowel diseases (IBD).
Globally, IBD affects approximately 10 million individuals, manifesting primarily as ulcerative colitis and Crohn’s disease, both of which remain incurable. However, treatments like mirikizumab offer hope by alleviating symptoms and improving patients’ quality of life.
Mirikizumab, marketed under the brand name Omvoh, received FDA approval for ulcerative colitis treatment in October 2023. The recent findings from Eli Lilly highlight the drug’s potential efficacy in managing Crohn’s disease, a condition often characterised by persistent bowel inflammation leading to significant gastrointestinal distress and potential long-term complications. An expert from Eli Lilly’s immunology division remarked on the challenges faced by those living with these conditions. Many current therapies do not achieve sustained clinical remission, and even when remission is achieved, it is often temporary.
The studies conducted by Eli Lilly underscore the need for innovative treatment strategies targeting more than just clinical remission. Traditional endpoints like bowel urgency and endoscopic results are gaining attention as critical measures of treatment efficacy. In one notable study, the LUCENT-2 clinical trial, participants who achieved clinical remission with mirikizumab after one year continued to experience positive outcomes over an additional two years of treatment. Specifically, 81% of these participants maintained long-term clinical remission, showcasing the drug’s potential for durable intestinal healing.
These findings provide healthcare providers with robust evidence to support clinical decision-making in IBD treatment. Mirikizumab demonstrated sustained benefits across various symptomatic, clinical, endoscopic, and histologic endpoints for up to three years, regardless of previous treatment failures with other biologics or inhibitors. Such outcomes represent key goals in reducing disease-related disability associated with ulcerative colitis.
Further reinforcing these findings, data from another study – the VIVID-2 clinical trial – was presented at the American College of Gastroenterology’s annual meeting in 2024. The study focused on the drug’s impact on moderately to severely active Crohn’s disease. Participants treated with mirikizumab exhibited high rates of clinical and endoscopic remission over five years. Remarkably, 96% of participants showed a measurable clinical response according to the Crohn’s Disease Activity Index (CDAI), and 87% were in clinical remission based on this index.
Crohn’s disease is a chronic condition driven by immune-mediated inflammation that can result in cumulative bowel damage if not adequately managed. The CDAI is a critical tool for assessing disease severity, combining patient-reported symptoms with objective blood tests. Achieving and sustaining CDAI remission remains a primary objective for healthcare providers treating Crohn’s disease.
The results of these studies bolster confidence in mirikizumab’s long-term efficacy and safety profile. They demonstrate that patients achieving remission with this medication may sustain endoscopic remission for up to five years. This adds to the growing body of evidence supporting mirikizumab, which is currently approved in the U.S. for treating moderately to severely active ulcerative colitis in adults and is under review for Crohn’s disease.
The underlying mechanism of these diseases involves inflammation triggered by overactivation of the IL-23 pathway. This protein plays a critical role in immune system activation, contributing to the chronic nature of both ulcerative colitis and Crohn’s disease. Mirikizumab acts as an interleukin-23p19 (IL-23p19) antagonist, selectively binding to the p19 subunit of the IL-23 protein. This action inhibits its interaction with the IL-23 receptor, thereby reducing inflammation.
Unchecked inflammation from these conditions can lead to disruptive symptoms like bowel urgency, significantly impacting patients’ health-related quality of life. Left untreated, these symptoms can lead to irreversible complications. There remains an unmet need for therapies that provide long-standing remission and effectively relieve disease burden.
The data presented at the ACG conference marks a significant milestone. Mirikizumab stands out as the first IL-23p19 antagonist to report sustained efficacy over multiple years for both ulcerative colitis and Crohn’s disease. It offers durable intestinal healing and relief from symptoms that matter most to patients, such as bowel urgency and achieving remission without corticosteroids.
A gastroenterologist not involved in the research highlighted the importance of new monoclonal antibody therapies like IL-23 drugs in addressing the underlying causes of both ulcerative colitis and Crohn’s disease. Traditional treatments such as tumour necrosis factor (TNF) inhibitors often lose effectiveness over time, necessitating an expanded arsenal of medications to manage these challenging conditions effectively.
Looking ahead, experts emphasise the need for head-to-head comparisons of emerging therapies for IBD. With several IL-23 drugs now available, such comparative trials could significantly enhance treatment strategies by identifying the most effective options for different patient populations.
Mirikizumab shows significant promise as a long-term treatment option for both ulcerative colitis and Crohn’s disease. These findings represent a beacon of hope for millions worldwide living with these chronic conditions. As research continues to evolve, patients and healthcare providers alike can look forward to more effective and sustainable treatment solutions.
