- 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.
People taking the drug mirikizumab achieved remission from ulcerative colitis almost twice as often as those taking a placebo, according to a study published in the New England Journal of Medicine.
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.
The participants who were considered responsive went on to the maintenance phase, LUCENT-2. The researchers measured via stool frequency and rectal bleeding.
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…
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