Mirikizumab reduces disease severity in Crohn’s, ulcerative colitis
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Mirikizumab correlated with a greater reduction in disease severity among patients with ulcerative colitis and moderate to severe Crohn’s disease, according to a poster presentation at the Crohn’s and Colitis Congress.
“Mirikizumab, an anti-IL-23p19 inhibitor, has demonstrated efficacy in patients with ulcerative colitis and moderately to severely active Crohn’s disease in a phase 2, randomized, double-blind, placebo-controlled study,” David T. Rubin, MD, AGAF, chief of gastroenterology, hepatology and nutrition at the University of Chicago Medicine, and colleagues wrote.
Rubin and colleagues evaluated 191 patients with IBD who received either mirikizumab 200 mg (31), 600 mg (32), 1,000 mg (64) or placebo (64) intravenously every 4 weeks during induction. Those who responded during the induction period ( 1 point improvement in Simple Endoscopic Score for CD) either continued IV treatment or received 300 mg mirikizumab subcutaneously every 4 weeks for 40 weeks; patients dosed with placebo and non-responders received a 1,000 mg dose IV during maintenance.
Patients rated their disease severity daily using the 6-point Patient’s Global Rating of Severity (PGRS) scale and at 4, 12 and 52 weeks using the 7-point Patient’s Global Rating of Change (PGRC) scale. Researchers compared average scores between groups, as well as markers of endoscopic response and remission.
According to the results, all patients dosed with mirikizumab demonstrated a greater reduction in PGRS scores at week 12, and those who received 600 mg demonstrated reduction as early as week 4 (mean PGRC: 2.5-2.8 vs. 3.6). Patients continued to demonstrate a reduction in disease severity and sustained improvement through maintenance.
“Patients with moderately to severely active CD treated with mirikizumab showed greater reduction in disease severity compared with placebo, with differences noted as early
as week 4,” Rubin concluded. “These improvements in patients’ disease severity and symptom severity were sustained or improved with continued maintenance treatment.”
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Rubin DT, et al. Poster P040. Presented at: Crohn’s and Colitis Congress; Jan. 20-22, 2022 (virtual meeting).
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