New drug enhances outcomes for ulcerative colitis patients.

New drug enhances outcomes for ulcerative colitis patients.

New Treatment for Ulcerative Colitis Approved in Europe

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People living with ulcerative colitis, a condition causing pain, bloody diarrhea, and an urgent need to use the toilet, may soon have a promising treatment option available. A new drug called mirikizumab (Omvoh) has been approved in Europe and is the first of its kind tested for this condition. It works by blocking interleukin-23, a key protein involved in triggering and maintaining gut inflammation.

Enhancing Quality of Life with Mirikizumab

An international team of researchers led by Amsterdam University Medical Centers conducted trials to test the safety and effectiveness of mirikizumab. The trials involved 1,281 adults with moderate to severe inflammation from ulcerative colitis. The results showed that rates of remission doubled, reaching up to 50%, in certain groups.

If approved in the United States, this innovative drug could provide better and safer symptom control, filling a gap in the marketplace. Currently, treatments for ulcerative colitis include steroids, anti-TNF inhibitors that suppress the immune system, and other medications targeting cytokines. However, mirikizumab stands out by blocking a single protein, making it potentially safer and more effective.

The lead researcher, Dr. Geert D’Haens, emphasizes the importance of restoration of quality of life and normality for those suffering from ulcerative colitis. The symptoms of this condition can vary, causing challenges for patients in getting their symptoms under control. These symptoms include bloody diarrhea, abdominal pain, anemia, fatigue, and fecal incontinence.

Improving Safety and Symptom Control

One of the significant advantages of mirikizumab is its safety profile. Unlike some other medications used to treat ulcerative colitis, mirikizumab does not increase the risk of infections or cancer. This is crucial, as chronic colon inflammation, a common consequence of the condition, already increases the risk of cancer. Furthermore, mirikizumab does not impact the liver or kidneys, making it a more desirable treatment option for patients.

In addition to reducing symptoms like bloody stool, mirikizumab also addresses a more limiting side effect of ulcerative colitis: fecal urgency. This symptom can significantly impact a person’s daily life, preventing them from leaving their homes due to an inability to control their bowels. By targeting interleukin-23, mirikizumab not only brings symptom relief but also aims to empower patients to regain control over their lives.

Research Findings and Future Prospects

In the trial, patients received mirikizumab or a placebo every four weeks for about three months. Among those treated with mirikizumab, 24.2% achieved remission, compared to only 13.3% who received the placebo. Encouragingly, the study showed that the drug continued to be effective in maintaining remission when administered at a smaller dose every four weeks for an additional 40 weeks.

Dr. Jason Hou, an associate professor of medicine at Baylor College of Medicine, highlights the importance of mirikizumab as a first-in-class medication for ulcerative colitis, specifically targeting interleukin-23. He acknowledges that even with the best available medications, a substantial number of patients still struggle to control their symptoms. Therefore, the expanding treatment landscape, including the introduction of mirikizumab, offers hope for patients.

The drug application for mirikizumab has already been submitted to the U.S. Food and Drug Administration (FDA). While the FDA requested further information regarding manufacturing, it is expected to be approved and available in the U.S. later this year. Mirikizumab has already been approved in Japan and was authorized in the European Union in May 2023 after the European Medicines Agency determined its benefits outweighed the risks.

The findings of this research, funded by Eli Lilly, were recently published in the New England Journal of Medicine. As the medical options for ulcerative colitis continue to expand, it is essential for both patients and healthcare providers to be aware of the growing number of treatment options available. Discussions between patients and healthcare providers regarding the best course of treatment should be encouraged to improve outcomes and enhance the quality of life for those living with ulcerative colitis.

More information

For more information about ulcerative colitis, please visit the U.S. National Institutes of Health website.

Sources

Geert D’Haens, MD, PhD, professor of gastroenterology, Amsterdam University Medical Center, Netherlands; Jason Hou, MD, associate professor of medicine-gastroenterology, Baylor College of Medicine, Houston; New England Journal of Medicine, June 29, 2023.