Mirikizumab Improves Bowel Movement Urgency in Ulcerative Colitis
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AUSTIN, Texas — Patients with moderately to severely active ulcerative colitis experienced improvements in bowel movement urgency after receiving mirikizumab, according to research presented at the Crohn’s and Colitis Congress.
Marla Dubinsky, MD, of the Icahn School of Medicine at Mount Sinai, told Healio Gastroenterology and Liver Disease that urgency is commonly reported by patients with UC and has a significant impact on their lives.
“[Urgency] is the symptom that’s keeping people up at night or keeping people away from their work,” she said. “Up until now, none of the therapies that have been approved for ulcerative colitis are based on whether they improved the symptom that patients probably suffer the most from.”
Researchers randomly assigned patients to receive intravenous placebo (n = 55), 50 mg (n = 59) or 200 mg (n = 56) of mirikizumab (Eli Lilly) with a possibility of exposure-based dose increases or mirikizumab fixed at 600 mg every 4 weeks (n = 51). After an efficacy assessment at week 12, researchers randomly assigned patients who achieved clinical response to maintenance treatment with either 200 mg mirikizumab subcutaneously every 4 weeks or every 12 weeks through 52 weeks. They defined clinical response as at least a 2-point reduction in a 9-point Mayo score and at least 35% from baseline, as well as either a decrease in rectal bleeding subscore greater than or equal to 1 or a rectal bleeding subscore of 0 or 1.
Investigators also assessed the differences in urgency among patients who had urgency at baseline for the first 12 weeks. They defined absence of urgency as no urgency symptoms for 3 consecutive days prior to each scheduled visit. During the maintenance period, they also calculated the proportion of patients with no urgency among patients who did have urgency at baseline and reached clinical response at week 12, regardless of urgency status at week 12.
After the first 12 weeks of treatment, patients in the 200 mg (39.3%) and 600 mg (43.1%) mirikizumab groups showed higher rates of achieving absence of urgency compared with the placebo group (18.2%; P = .016 and P = .006, respectively). Patients who achieved clinical response who went onto the maintenance period sustained the improvement in urgency.
“We will have to validate this further and see how the regulatory agencies respond to us bringing this in as a new patient-outcome as part of holding all therapeutics accountable for making that change in a very important patient-reported symptom,” Dubinsky said. – by Alex Young
Reference:
Dubinsky. P068. Presented at: Crohn’s and Colitis Congress; Jan. 23-25, 2020; Austin, Texas.
Disclosure: Dubinsky reports being on the steering committee for the mirikizumab program and serving as an advisor/consulting for Eli Lilly.
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