FDA-approved drug for ulcerative colitis also effective for Crohn's
Mirikizumab is a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis. Researchers estimate about 10 million people around the world live with inflammatory bowel disease (IBD). There are two main types of IBD: ulcerative colitis and Crohn’s disease. There is currently no cure for IBD. Medications, surgery, and lifestyle changes can help alleviate symptoms
One such medication is mirikizumab — sold under the brand name Omvoh — which received Food and Drug Administration (FDA) approval for the treatment of ulcerative colitis in October 2023. Recently, the drug’s manufacturer, pharmaceutical company Eli Lilly, released the findings of two new studies regarding the long-term efficacy and safety of mirikizumab for not only ulcerative colitis, but also Crohn’s disease.
81% ulcerative colitis cases maintain long-term remission
During the LUCENT-3 trial — whose results recently appeared in the journal Inflammatory Bowel Diseases and presented at the 2024 American College of Gastroenterology (ACG) Annual Meeting — researchers examined the long-term effects of study participants treated with mirikizumab during the original LUCENT clinical trial program.
Among study participants who achieved clinical remission with mirikizumab at 1 year in the LUCENT-2 clinical trial, researchers found after an additional 2 years of treatment — or up to 3 years total — that 81% of participants maintained long-term clinical remission.
87% of those with Crohn’s have clinical remission for up to 5 years
Eli Lilly researchers also recently presented data from the VIVID-2 clinical trial for mirikizumab in the treatment of moderately to severely active Crohn’s disease at ACG 2024. Data from this study showed that study participants treated with mirikizumab maintained high rates of clinical and endoscopic remission for up to 5 years, with 96% of participants having a clinical response measurable by the Crohn’s Disease Activity Index (CDAI), and 87% in clinical remission based on the CDAI.
What exactly is mirikizumab?
Mirikizumab is a type of medication called an interleukin-23p19 (IL23p19) antagonist. Inflammation due to the overactivation of the IL-23 pathway — a protein that can activate a person’s immune system — plays a critical role in how ulcerative colitis and Crohn’s disease develop and persist as chronic diseases. Mirikizumab is an interleukin-23p19 (IL-23p19) antagonist that selectively binds to the p19 subunit of the IL-23 protein and inhibits its interaction with the IL-23 receptor, thus reducing its effects in inflammation.
The data presented at ACG show that mirikizumab is the first and only IL-23p19 antagonist to report multi-year, long-term sustained efficacy in both ulcerative colitis and Crohn’s disease, providing durable intestinal healing over time and relief from the key symptoms that matter most to patients, including bowel urgency and remission without the need for corticosteroids.
