- A new medication being developed to treat ulcerative colitis showed promise in a recent clinical trial.
- Researchers said people taking the drug, mirikizumab, achieved remission from ulcerative colitis twice as often as study participants who took a placebo.
- Experts say the findings are encouraging, but the drug hasn’t been approved by federal regulators yet and more clinical trials are needed.
In their research, scientists tested the safety and efficacy of mirikizumab, a new injectable medication that is being developed to treat ulcerative colitis.
The Food and Drug Administration has not yet approved mirikizumab for use in the United States.
In their findings, the researchers reported that people had a better clinical response, experienced endoscopic remission, and had less bowel movement urgency than those who took a placebo.
There were two phase 3, double-blind, placebo-controlled trials totaling 52 weeks of treatment.
The trial included 1,281 adults with ulcerative colitis who were experiencing moderate to severe inflammation.
The first, LUCENT-1, lasted for 12 weeks. For every one participant who received a placebo, three received 300 mg of mirikizumab. In all, 868 received mirikizumab, and 294 received a placebo.
At the end of the 12 weeks, 365 people who received mirikizumab reported responsiveness and 179 placebo recipients did.
During the second stage – the maintenance phase – participants received either 200 mg of mirikizumab or a placebo.
At week 40 of the maintenance phase (or week 52 of both combined), nearly 50% of people who received mirikizumab and 25% of the placebo group achieved remission.
The research was funded by the pharmaceutical company Eli Lilly.
Longer trials are ongoing to assess more prolonged efficacy and safety of mirikizumab.
“This study shows that we have another tool for people with ulcerative colitis and this might help those that do not respond to other medications,” said Dr. Ashkan Farhadi, a gastroenterologist at MemorialCare Orange Coast Medical Center in California who was not involved in the study. “However, I am not jumping up and down excitedly over the numbers.”
“And we have a long time before we can get this to the patients. First is the phase 4 trial. If that gets us to the next step, we have the insurance companies to get through,” Farhadi told Medical News Today.
“The cost for these types of medicines is outrageous, and insurance companies often make us jump through hoops for approval. For example, they might say the patient needs to try several other drugs first,” he added.
“Overall, I think it is good to have another tool. But right now, the numbers would not make this my first choice,” Farhadi said.
Ulcerative colitis is a chronic inflammatory bowel disease.
It is considered an autoimmune-related disease that causes inflammation and sores – ulcers – in the lining of the rectum and colon.
The symptoms include:
- Blood in the stools
- Abdominal pain
There is no cure for ulcerative colitis. According to the Crohn’s & Colitis Foundation, the treatments include:
- medication to suppress inflammation
- a combination of different medications
Doctors also recommend a diet consisting of soft, bland foods during a flare. They may also suggest reducing spicy and high-fiber foods.
About two-thirds of people with ulcerative colitis who take medication will achieve remission, according to the American Academy of Family Physicians. About 80% of those will maintain remission.
“This is very hard to understand,” said Dr. Arun Swaminath, the chief of gastroenterology and director of the Inflammatory Bowel Program at Northwell Lenox Hill Hospital in New York, who was not involved in the study. “Other autoimmune conditions, such as rheumatoid arthritis, have an 80 to 90 percent response rate. But we can’t get there for ulcerative colitis. It might be that the burden of inflammation is so high in inflammatory bowel diseases (IBD).”
“Medical professionals are always excited when a new medicine for IBD comes out. Mirikizumab has a different mechanism of action,” Swaminath told Medical News Today. “It will act differently in the body than other medications.”
“There are some positives, such as this study enrolled many people in the severe category,” he added. “When studies enroll mostly patients in the ‘moderate’ category, it is hard to know how much the medicine works. I was very encouraged to see participants with severe disease still get positive results.”
The current study was a phase 3 trial.
Phase 3 trials look at the safety of a new drug and also how well it works over a longer period than in earlier trials, according to the
If mirikizumab is approved by the FDA, the next step would likely be a phase 4 clinical trial. Phase 4 trials often include thousands of people.
“Because so many more people are included in the next phase, it might answer some lingering questions,” Swaminath said. “For example, when reading the study, I wondered about people who previously took Stelara. They were excluded from phase 3 – does that mean they won’t be good candidates for this medicine? Also, there were four cases of cancer – two in the induction phase and two in the maintenance phase. Were those cancers already present? We will need to follow the next phase to see what happens when the medicine is given to a large population.”