2023-06-29 16:22:29
The protein interleukin-23 causes and maintains inflammation, both in the gut in Crohn’s disease and ulcerative colitis, and in the chronic skin disease psoriasis. Blocking interleukin-23 with specific therapeutic antibodies has previously been shown to be highly effective in psoriasis and Crohn’s disease.
Mirikizumab is one such antibody and has now been tested for the first time in ulcerative colitis, say the researchers, who have published the results of their study in New England Journal of Medicine.
Clinical stage
In recent years, a large group of researchers from around the world conducted two Phase III clinical trials to assess the safety and efficacy of mirikizumab. It involved a group of 1281 adult patients with ulcerative colitis with moderate to severe inflammation. A control group of comparable patients with ulcerative colitis received a placebo.
Patients received 300 mg of mirikizumab or placebo by infusion every four weeks for a total of twelve weeks (LUCENT-1 study). If patients responded to mirikizumab within these 12 weeks, they continued in the LUCENT-2 study. This is the case in 544 of the 1281 patients. They received 200 mg mirikizumab or placebo by injection every four weeks for 40 consecutive weeks.
Available in Europe
Patients treated with mirikizumab were more likely to have their disease resolved at both the end of the LUCENT-1 and LUCENT-2 studies than patients treated with placebo.
The patients who received mirikizumab more often had an improvement in the symptoms of bloody diarrhea. There was also more frequent complete recovery of the intestinal mucosa at endoscopy and less urge to have a bowel movement than in the patients who received placebo.
Furthermore, side effects were found to be no more common with mirikizumab treatment than with placebo, the researchers conclude, who hope that mirikizumab will be available as a treatment option in Europe this year.
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