FDA approved drug for ulcerative colitis, also effective for Crohn’s disease

• About 10 million people globally live with inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn’s disease.

• There is currently no cure for IBD.

• Mirikizumab is a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis.

• The pharmaceutical company Eli Lilly recently released the findings of two studies on the long-term efficacy and safety of mirikizumab not only for ulcerative colitis but also for Crohn’s disease.

Researchers estimate approx 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. Medicines, surgery, and lifestyle changes can help relieve symptoms

Such a drug is mirikizumab — sold under the brand name Omg – which received the Food and Drug Administration (FDA) approval for the treatment of ulcerative colitis in October 2023.

Recently, the manufacturer of the drug, the pharmaceutical company Eli Lilly, ISSUED the findings of two new studies on the long-term efficacy and safety of mirikizumab not only for ulcerative colitis but also for Crohn’s disease.

“Despite continued advances, people living with ulcerative colitis and Crohn’s disease are still searching for treatments that can address difficult-to-manage symptoms like bowel urgency and provide long-lasting results.” Anabela Cardoso, MDsaid Senior Vice President of Medical Affairs Lilly Immunology Today’s medical news.

“Current therapies often fail to achieve clinical remission, and of the patients who achieve clinical remission, a substantial proportion lose it within the first year,” she noted.

“To better assess the impact of these diseases on a patient’s life, it is important to consider the use of more innovative treatment measures beyond clinical remission, including bowel urgency and endo-histological objectives after initiation of treatment and in the long term,” added Cardoso.

81% of ulcerative colitis cases maintain long-term remission

During The LUCENT-3 process — the results of which recently appeared in the journal Inflammatory bowel diseases and presented at 2024 American College of Gastroenterology (ACG) Annual Meeting. — researchers looked at the long-term effects of study participants treated with mirikizumab during the original study LUCENT clinical trial program.

Among study participants who achieved clinical remission with mirikizumab at 1 year in LUCENT-2 clinical trialresearchers found after 2 more years of treatment—or up to 3 years in total—that 81 percent of participants maintained long-term clinical remission.

“These long-term data show that mirikizumab can provide durable intestinal healing and relief of the key symptoms that matter most to patients, providing healthcare providers with the evidence needed to inform clinical decision-making in treating inflammatory bowel disease,” Cardoso said.

“Mirikizumab also provided sustained benefit in symptomatic, clinical, endoscopic and histological endpoints for up to three years, regardless of prior failure TNF inhibitors, tofacitinibor other biological substances,” she continued. “These key goals in the treatment of ulcerative colitis to minimize disease-related disability.”

87% of those with Crohn’s disease are in clinical remission by 5 years

Eli Lilly researchers also recently present data from 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 measurable clinical response by Crohn’s Disease Activity Index (CDAI)and 87% in clinical remission based on CDAI.

“Crohn’s disease is a chronic, immune-mediated disease characterized by intestinal inflammation that can lead to cumulative intestinal damage and disability,” Cardoso explained. “The CDAI is a measure of the severity of Crohn’s disease that combines the patient’s symptoms and blood tests, and achieving and sustaining CDAI remission is a goal for healthcare providers when treating Crohn’s disease.”

What exactly is mirikizumab?

Mirikizumab is a type of medicine called an antagonist of interleukin-23p19 (IL23p19)..

“Inflammation due to overactivation 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,” Cardoso explained.

“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, thereby reducing its effects on inflammation,” she added.

“Inflammation in ulcerative colitis and Crohn’s disease can lead to disruptive symptoms, including bowel urgency, which can lead to decreased health-related quality of life and potentially irreversible complications for patients if left untreated,” Cardoso continued. “There remains a need to ensure and maintain long-lasting remission and reduce disease burden.”

“Data presented at ACG show that mirikizumab is the first and only IL-23p19 antagonist to report sustained multi-year and long-term efficacy in both ulcerative colitis and Crohn’s disease, providing durable intestinal healing over time and improving the key symptoms that matter most to patients, including bowel urgency and remission without the need for corticosteroids“, she further elaborated.

“We need more drugs” for IBD

MNT also spoke to Rudolph Bedford, MDa board-certified gastroenterologist at Providence Saint John’s Health Center in Santa Monica, CA, about this study.

“What we see is that these drugs are monoclonal antibodiesIL-23 drugs, target hotspots that cause both ulcerative colitis and Crohn’s disease,” Bedford, who was not involved in the research, told us. “And they certainly all added to our armamentarium in the treatment of both diseases.”

“Because with our old drugs, our tumor necrosis factors (TNF), there are many times when the drug begins to wear out its welcome, so to speak, in the sense that (in) patients they are no longer effective,” he continued. “So we need more drugs in our arsenal to add to what we’re using right now.”

Going forward, Bedford said he would like to see more head-to-head comparisons of these types of therapies for IBD.

“We have some of these IL-23 drugs now,” he told us. “We would like to see more head-to-head trials with these different drugs so that we can really help our patients in terms of refining the best-in-class, so to speak, of these drugs.”

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