New drug puts ulcerative colitis and Crohn’s disease in remission

• Approximately 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 currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis.
• Pharmaceutical company Eli Lilly recently released the findings of two studies examining the long-term efficacy and safety of mirikizumab, not only for ulcerative colitis, but also for Crohn’s disease.

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 relieve symptoms

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

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

“Despite continued progress, people with ulcerative colitis and Crohn’s disease are still looking for treatments that can address difficult-to-manage symptoms, such as intestinal urgency, and provide lasting results over time.” Anabela Cardoso, MDsaid senior vice president for Lilly Immunology Medical Affairs Medical news today.

“Current therapies often fail to achieve clinical remission, and of those patients who do achieve clinical remission, a significant 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 that go beyond clinical remission, including bowel urgency and endo-histological endpoints after initiation of treatment and in the longer term,” Cardoso added.

Among study participants who achieved clinical remission after 1 year with mirikizumab LUCENT-2 clinical trialResearchers found that after another two years of treatment – ​​or up to three years total – 81% of participants maintained long-term clinical remission.

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

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

Eli Lilly researchers recently too 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 a high rate of clinical and endoscopic remission for up to 5 years, with 96% of participants demonstrating a clinical response measurable by 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 intestinal inflammation that can lead to cumulative intestinal damage and disability,” explains Cardoso. “CDAI is a measure of the severity of Crohn’s disease that combines patient symptoms and blood tests. Achieving and maintaining CDAI remission is a goal for healthcare providers in the management of Crohn’s disease.”

“These findings strengthen the efficacy 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 five years. These results build on the growing body of evidence for mirikizumab, which is approved in the US for the treatment of moderately to severely active ulcerative colitis in adults (and) under review by the US FDA for moderately to severely active Crohn’s disease.”

“Inflammation due to the overactivation of the IL-23 pathway – a protein that can activate a person’s immune system – plays a crucial 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 from ulcerative colitis and Crohn’s disease can lead to disruptive symptoms, including bowel urgency, which can result in reduced 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 alleviate the burden of disease.”

“The data presented at ACG demonstrate 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 long-term durable intestinal healing and relief of key symptoms . are most important to patients, including bowel urgency and remission without the need for it corticosteroidsshe further explained.

MNT also talked 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 antibodiesThe IL-23 drugs target the focal points that cause both ulcerative colitis and Crohn’s disease,” Bedford, who was not involved in the study, told us. “And they certainly all contributed to our arsenal in treating both diseases.”

“Because with our old medications, our tumor necrosis factors (TNFs), it often happens that the drug begins to wear out its welcome, so to speak, because it is no longer effective in the patients,” he continued. “So we need more drugs in our arsenal to supplement what we are currently using.”

In the future, 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 would like to see more head-to-head studies with these different medications so that we can really help our patients hone in on the best of breed, so to speak, of these medications.”