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A drug that has already gained FDA approval for the treatment of ulcerative colitis is also effective in the treatment of Crohn’s, new data suggest. Brothers91/Getty Images
  • 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.
  • Pharmaceutical company Eli Lilly recently released findings of two studies regarding the long-term efficacy and safety of mirikizumab for not only ulcerative colitis, but also Crohn’s disease.

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.

“Despite continued advances, people living with ulcerative colitis and Crohn’s disease are still seeking treatments that can address difficult-to-manage symptoms, such as bowel urgency, and provide lasting results over time,” Anabela Cardoso, MD, senior vice president for Lilly Immunology Medical Affairs told Medical News Today.

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

“To better evaluate 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-histologic endpoints after treatment initiation and longer-term,” Cardoso added.

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.

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

“Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic, and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib, or other biologics,” she continued. “These are key goals in the treatment of ulcerative colitis to minimize disease-related disability.”

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.

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

“These findings reinforce the efficacy and safety of mirikizumab to date, and also demonstrate that people who achieve remission with mirikizumab can sustain long-term endoscopic remission for up to 5 years. These results build on the growing body of evidence for mirikizumab, which is approved in the U.S. for the treatment of moderately to severely active ulcerative colitis in adults [and] under review with the U.S. FDA for moderately to severely active Crohn’s disease.”

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,” 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, thus reducing its effects in inflammation,” she added.

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

“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,” she further detailed.

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

“What we’re seeing is that these drugs, they are monoclonal antibodies, IL-23 drugs, are honing in on the points of interest that cause both ulcerative colitis and Crohn’s disease,” Bedford, who was not involved in the research, told us. “And certainly they’ve all added to our armamentarium in the treatment of both of these diseases.”

“Because with our old drugs, our tumor necrosis factors (TNFs), there are many times that the drug begins to wear out its welcome, so to speak, in that [in] the patients they’re no longer effective,” he continued. “So we need more drugs in our armamentarium to add on to what we’re utilizing at this point in time.”

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

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