▎WuXiEdited by Kant Content Team

Eli Lilly and Company recently announced the results of two multi-year Phase 3 trials at the American College of Gastroenterology (ACG) annual meeting, showing that patients with ulcerative colitis (UC) and Crohn's disease (CD) treated with its drug Omvoh (mirikizumab) maintained stable long-term remission.

Long-term Data for Adult Patients with Ulcerative Colitis

LUCENT-3 is the long-term Phase 3 extension study of LUCENT-1 and LUCENT-2, designed to evaluate the long-term efficacy of mirikizumab in patients with UC. In the LUCENT-3 study,Mirikizumab Achieved Long-term Remission, Including Histologic-Endoscopic Mucosal Healing, in Patients with Moderate to Severe Active UC.In addition,Mirikizumab Provides Patients with Continuous Benefits for up to Three Years in Symptoms, Clinical, Endoscopic, and Histological Endpoints, regardless of whether UC patients had previously been resistant to TNF inhibitors, tofacitinib, or other biologics. Observational case analysis showed that patients who achieved one year of clinical remission in the LUCENT-2 study observed after an additional two years (three years total) of treatment:

• 81% of patients maintained long-term clinical remission.

• 82% achieved long-term endoscopic remission

• 72% achieved mucosal healing

• 79% achieved clinical remission without corticosteroids

• The patient's intestinal urgency symptom score continued to show significant improvement.

Image Source: 123RF

Long-term Data for Adult Patients with Crohn's Disease

New data from the VIVID-2 long-term extension study show that patients with moderate to severe active Crohn's disease maintain high levels of clinical and endoscopic remission over the long term after treatment with mirikizumab. Observational case analysis indicates,After an additional three years (a total of five years) of treatment, with the following results:

• According to the Crohn's Disease Activity Index (CDAI),96% of patientsShow clinical response

• 87% of patients achieved clinical remission (based on CDAI).

• 76% achieved endoscopic response

• 54% of patients achieved endoscopic remission.

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, blocking IL-23-mediated inflammatory responses.The therapy was approved in October 2023.FDA Approval, becoming the first IL23p19 antagonist for the treatment of moderate to severe active UC, and has been approved in 44 countries or regions worldwide.

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References:

[1] Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease. Retrieved October 29, 2024 from https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long

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