Using mirikizumab, a monoclonal antibody that can inhibit interleukin-23, to treat ulcerative colitis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by An Thien Duc Le |
Posted on July 29th, 2023
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Due to its pro-inflammatory effect in ulcerative colitis, many therapeutic agents that inhibit IL-23 have been tested and approved to be used in the United States. IL-23 can be divided into two subunits: the p40 and p19 subunits. Previous phase 2 clinical trial study had shown Mirikizumab, an antibody that can target the p19 subunit of IL-23, can be a promising treatment. Thus, the pharmaceutical company, Eli Lilly, had sponsored a phase 3 clinical trial to assess the effectiveness and safety of Mirikizumab in treating ulcerative colitis.
The study included 1281 patients who had been diagnosed with moderate to severe ulcerative colitis using the modified Mayo scale. Additional endoscopic and histologic examinations were also performed. These patients were either contraindicated for or were not responding to either glucocorticoids or immunomodulating treatments. The patients were randomly assigned to receive either placebo or mirikizumab intravenously, at a dose of 300 mg every 4 weeks. After 12 weeks of treatment, the researchers found that more patients in the mirikizumab group achieve clinical remission than those in the placebo group. The patients that had a clinical response to mirikizumab were then invited to participate in the following trial to test the maintenance regimen of mirikizumab. During which, the patients were randomly assigned to receive either placebo or 200 mg of mirikizumab subcutaneously every 4 weeks. After 40 weeks, clinical remission was observed in more than half of those who were treated with mirikizumab; whereas, improvement was observed in only one quarter of the placebo group. In terms of safety, those in the mirikizumab group reported a higher incidence of nasopharyngitis and arthralgia. Following these promising results, follow-up studies should be conducted to compare the efficacy and safety of mirikizumab with other approved treatments for ulcerative colitis such as ustekinumab and risankizumab.
The study included 1281 patients who had been diagnosed with moderate to severe ulcerative colitis using the modified Mayo scale. Additional endoscopic and histologic examinations were also performed. These patients were either contraindicated for or were not responding to either glucocorticoids or immunomodulating treatments. The patients were randomly assigned to receive either placebo or mirikizumab intravenously, at a dose of 300 mg every 4 weeks. After 12 weeks of treatment, the researchers found that more patients in the mirikizumab group achieve clinical remission than those in the placebo group. The patients that had a clinical response to mirikizumab were then invited to participate in the following trial to test the maintenance regimen of mirikizumab. During which, the patients were randomly assigned to receive either placebo or 200 mg of mirikizumab subcutaneously every 4 weeks. After 40 weeks, clinical remission was observed in more than half of those who were treated with mirikizumab; whereas, improvement was observed in only one quarter of the placebo group. In terms of safety, those in the mirikizumab group reported a higher incidence of nasopharyngitis and arthralgia. Following these promising results, follow-up studies should be conducted to compare the efficacy and safety of mirikizumab with other approved treatments for ulcerative colitis such as ustekinumab and risankizumab.