New drug leads to remission of ulcerative colitis and Crohn’s disease

• About 10 million people worldwide live with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease.
• There is currently no cure for IBD.
• Mirikizumab is a drug approved by the US Food and Drug Administration (FDA) for the treatment of ulcerative colitis.
• The pharmaceutical company Eli Lilly recently published the results of two studies regarding the long-term effectiveness and safety of mirikizumab not only in ulcerative colitis, but also in Crohn’s disease.

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.

One of these drugs is mirikizumab — marketed 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, published the results of two new studies regarding the long-term effectiveness and safety of mirikizumab not only in ulcerative colitis, but also in Crohn’s disease.

“Despite ongoing advances, people living with ulcerative colitis and Crohn’s disease are still seeking treatments that can eliminate difficult-to-treat symptoms, such as bowel urges, and provide lasting results over time,” Anabela Cardozo, Dr. Medical Sciences, Senior Vice President, Lilly. The immunologist-medical department told Medical news today.

“Current treatments often do not achieve clinical remission, and of patients who achieve clinical remission, a significant proportion lose it within the first year,” she noted.

“To better appreciate the impact of these diseases on a patient’s life, it is important to consider more innovative treatments beyond clinical remission, including defecatory urgency and endohistological endpoints after the start of treatment and in the long term,” Cardozo added.

Among study participants who achieved clinical remission with mirikizumab for 1 year in the LUCENT-2 clinical trial, investigators found that after an additional 2 years of treatment—or a total of up to 3 years—81% of participants maintained long-term clinical remission.

“These long-term data show that mirikizumab can provide long-lasting gut healing and relief of key symptoms that matter most to patients, providing healthcare providers with the evidence needed to make clinical decisions in the treatment of inflammatory bowel disease,” Cardoso said.

“Mirikizumab also provided sustained benefits across symptomatic, clinical, endoscopic and histological measures for up to three years, regardless of prior treatment failure. TNF inhibitorstofacitinib or other biologics,” she continued. “These are key goals in the treatment of ulcerative colitis, aimed at minimizing the disability associated with the disease.”

Eli Lilly researchers also recently presented data from the VIVID-2 clinical trial of mirikizumab for the treatment of moderate to severe Crohn’s disease at ACG 2024.

Data from this study showed that study participants receiving mirikizumab maintained high rates of clinical and endoscopic remission for up to 5 years, with 96% of participants experiencing clinical response as measured by Crohn’s Disease Activity Index (CDAI)and 87% in clinical remission according to 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 Crohn’s disease severity that combines a patient’s symptoms and blood tests, and achieving and maintaining CDAI remission is the goal of healthcare providers when treating Crohn’s disease.”

“These results confirm the effectiveness and safety of mirikizumab to date and also demonstrate that people who achieve remission with mirikizumab can maintain long-term endoscopic remission for up to 5 years. These results build on a growing body of data on mirikizumab, which is approved in the US for the treatment of moderately to severely active ulcerative colitis in adults (and) is under review by the US FDA for moderately to severely active Crohn’s disease.”

“Inflammation due to overactivation of the IL-23 pathway—a protein that can activate the human immune system—plays a critical role in how ulcerative colitis and Crohn’s disease develop and persist as chronic diseases,” Cardozo 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 effect on inflammation,” she added.

“Inflammation caused by ulcerative colitis and Crohn’s disease can lead to devastating symptoms, including urge to defecate, 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 achieve and maintain long-term remission and reduce the burden of disease.”

“Data presented at the ACG meeting show that mirikizumab is the first and only IL-23p19 antagonist reported to have multi-year and long-term sustained efficacy in both ulcerative colitis and Crohn’s disease, providing long-lasting intestinal healing over time and relief key symptoms that are most important to patients, including bowel urgency and remission without the need for corticosteroids,” she explained.

MNT also spoke with Rudolph Bedford, MD, a board-certified gastroenterologist at Providence Saint John Health Center in Santa Monica, California, about this study.

“We see that these drugs, they monoclonal antibodies“IL-23 drugs are honing in on interesting targets that cause both ulcerative colitis and Crohn’s disease,” Bedford, who was not involved in the study, told us. “And, of course, they all add to our arsenal of treatments for both of these diseases.”

“Because with our old drugs, our tumor necrosis factors (TNF), in many cases the drug begins to lose its effectiveness, so to speak, as (in) patients it ceases to be effective,” he continued. “So we need more drugs in our arsenal to add to what we currently use.”

Looking ahead, Bedford said he would like to see more head-to-head comparisons of these types of IBD treatments.

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