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Mirikizumab met both co-primary end points and all secondary end points at week 52, according to results presented at Digestive Disease Week in Washington DC.
Mirikizumab (Omvoh; Eli Lilly) demonstrated statistically significant and clinically meaningful improvements across clinical and endoscopic end points at 1 year when compared with the placebo for individuals with moderately to severely active Crohn disease (CD), with or without previous biologic failure, according to a news release by the company. The results of the first phase 3 trial for the drug were presented at the 2024 Digestive Disease Week in Washington, DC.1
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According to the company, mirikizumab met both co-primary end points and all secondary end points at week 52, including proportion of individuals achieving clinical response at week 12 and clinical remission at week 52, and the proportion of individuals achieving clinical response at week 12 and endoscopic response at week 52.1
Investigators included individuals who were diagnosed with moderate to severe CD for at least 3 months prior to baseline and who had an intolerance, loss of response, or inadequate response to conventional or biologic therapy. Patients were excluded if they were diagnosed with ulcerative colitis, inflammatory bowel disease, or short bowel syndrome; received any monoclonal antibodies binding to interleukin-23; had a bowel resection within 6 months; had stoma, ileoanal pouch, or ostomy; or currently have or are suspected to have an abscess.2
In the study, the investigators administered mirikizumab, ustekinumab, and the placebo intravenously and subcutaneously for all interventions.2 There were 1065 adults included in the study, with 579 receiving mirikizumab, 287 receiving ustekinumab, and 199 receiving the placebo.3
The abstract authors noted that the baseline characteristics were balanced across the 3 treatment arms, and patients who were treated with mirikizumab achieved all secondary end points compared with the placebo arm. Mirikizumab also achieved non-inferiority compared with ustekinumab for clinical remission.3
Superiority to ustekinumab for endoscopic response was not achieved, although patients who had biologic failure and who received mirikizumab had a trend toward greater response rates for endoscopic response and clinical remission.3
For mirikizumab, approximately 39.3% of individuals who were bio-naïve and 26.7% who were bio-failed achieved week 12 clinical response and week 52 endoscopic response compared with the placebo at 11.8% and 6.2%, respectively. Additionally, 47.3% and 44.4% of individuals taking mirikizumab achieved clinical response at week 12 and clinical remission at week 52, respectively, compared with individuals receiving the placebo at 26.5% and 12.4%, respectively.1
Furthermore, the safety profile in the study was generally consistent with the known safety profile of the drug, with treatment-emergent adverse events (AEs) similar for mirikizumab and ustekinumab at 78.6% and 77.3%, respectively. The most common AEs included COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis, and injection site reaction. Rates for serious AEs were comparable in the 2 groups at 10.3% and 10.7%, respectively.3
