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Eli Lilly recently announced new data from a Phase 2 study of a new anti-inflammatory drug mirikizumab in the treatment of ulcerative colitis (UC), showing that during a 12-week induction therapy period, the changes in gene expression in UC patients induced by mirikizumab were maintained.
mirikizumab is a humanized IgG4 monoclonal antibody that targets the p19 subunit of IL-23.
Another analysis conducted for patients with moderate to severe UC assessed meaningful improvement in bowel urgency, a common symptom of UC, which is associated with higher disease activity levels, lower work efficiency, and poorer quality of life.
Inflammatory bowel disease: treatment target (picture from document PMID30478416)
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In this analysis, a set of differentially expressed gene transcripts were identified in patients who responded to mirikizumab, but not in patients who responded to placebo at 12 weeks
In patients treated with mirikizumab, the results observed at 12 weeks lasted for a year
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In this study, half of UC patients (50%, n=10) reported that a 1 point change in urgent NRS would be a meaningful change, indicating improved emotional health and more confidence in leaving home or work
One-quarter of the respondents (25%, n=5) said that 2 points of improvement in urgent NRS need to be considered meaningful, and another 25% (n=5) said that 3 points or More changes can improve the quality of life
Importantly, in 75% of patients who support the 1- to 2-point change of urgent NRS, the initial score of urgent NRS is between 2 and 9, which shows that this change is meaningful regardless of the individual's degree of intestinal urgency.
Prentice Stovall, Head of Global Development of Immunology at Eli Lilly, said: "We are delighted to present these findings at ECCO.
Original source: Mirikizumab Up-Regulates Genes Associated with Mucosal Healing in Ulcerative Colitis for Up to One Year in Phase 2 Study