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

• Approximately 10 million people worldwide 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 published the results of two studies on 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. Medication, surgery, and lifestyle changes can help relieve symptoms

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

Recently, the drug's manufacturer, pharmaceutical company Eli Lilly, published the results of two new studies on the long-term effectiveness and safety of mirikizumab not only in ulcerative colitis but also in Crohn's disease.

“Despite continued advances, people with ulcerative colitis and Crohn's disease are still seeking treatments that can treat difficult-to-manage symptoms like bowel urgency and provide lasting results over time,” says Anabela Cardoso, MD, senior vice president of Lilly Immunology Medical Affairs said Medical News Today.

“Current therapies often do not result in clinical remission, and of those patients who do achieve clinical remission, a significant 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 intestinal urgency and.” endo-histological endpoints after starting treatment and in the longer term,” Cardoso added.

Among study participants who achieved clinical remission with mirikizumab after one year in the LUCENT-2 clinical trial, after an additional two years of treatment – or up to three years total – researchers found that 81% of participants maintained long-term clinical remission .

“These long-term data show that mirikizumab can provide lasting healing of the gut and relief from the key symptoms that matter most to patients. “They give health care providers the evidence they need to support clinical decision-making in the treatment of inflammatory bowel disease,” said Cardoso.

“Mirikizumab also provided sustained benefits in symptomatic, clinical, endoscopic and histologic endpoints for up to three years, regardless of prior failure TNF inhibitorsTofacitinib or other biologics,” she continued. “These are important 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 for the treatment of moderately to severely active Crohn's disease at ACG 2024.

Data from this study showed that subjects treated with mirikizumab maintained high clinical and endoscopic remission rates for up to 5 years, with 96% of subjects demonstrating a clinical response measurable by outcomes 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,” Cardoso explained. “CDAI is a measure of Crohn's disease severity that combines patient symptoms and blood tests. Achieving and maintaining CDAI remission is a goal for healthcare providers when treating Crohn's disease.”

“These results support the efficacy and safety of mirikizumab to date and also show that people who achieve remission with mirikizumab can maintain 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 United States for the treatment of moderately to severely active ulcerative colitis in adults [and] is currently under review by the US FDA for moderately to severely active Crohn’s disease.”

“Inflammation due to overactivation of the IL-23 signaling 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 effect on inflammation,” she added.

“Inflammation from ulcerative colitis and Crohn's disease can result in bothersome symptoms, including bowel urgency, which can lead to reduced health-related quality of life and potentially irreversible complications for patients if left untreated,” continued Cardoso. “There remains a need to ensure 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 multiyear, long-term, sustained efficacy in both ulcerative colitis and Crohn's disease, durable gut healing over time, and “Provides relief of key symptoms.” “Most important to patients, including bowel urgency and remission, without the need for corticosteroids,” she continued.

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

“What we see is that these drugs are monoclonal antibodies“IL-23 drugs focus on the points that cause both ulcerative colitis and Crohn’s disease,” Bedford, who was not involved in the research, told us. “And certainly they have all enriched our repertoire in the treatment of these two diseases.”

“Because with our old drugs, ours Tumor necrosis factors (TNFs) it often happens that the drug loses its effect, so to speak [in] “They are no longer effective in patients,” he continued. “So we need more drugs in our repertoire to complement what we currently use.”

Going 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 would like to see more head-to-head trials of these different drugs so that we can really help our patients achieve the best-in-class, so to speak, of these drugs.”