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WASHINGTON, DC — The selective interleukin (IL)–23p29 monoclonal antibody mirikizumab demonstrated safety and efficacy in people with moderate to severe Crohn’s disease compared with placebo up to 52 weeks, according to results of the phase 3 randomized, double blind, treat-through VIVID-1 study.
Bruce E. Sands, MD, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York, reported the findings in a poster (Abstract Su1801) here at Digestive Disease Week (DDW) 2024.
The FDA approved mirikizumab (Omvoh, Eli Lilly) to treat moderate to severe ulcerative colitis in October 2023.
Sands and a team of US and international collaborators studied 1065 adults with Crohn’s disease or fistulizing Crohn’s disease for 3 months or more, with a mean duration of more than 7 years. At baseline, participants had a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 7 or more and reported an inadequate response, lost response, or intolerance to other therapy.
A total of 579 people were randomly assigned to mirikizumab and another 199 to placebo. Another 287 patients received ustekinumab; though they were not included in this current analysis, the findings were presented separately at DDW 2024.
Mean age of study participants was 30 years, and men comprised 57%-59% of the groups. Nearly half (49%) of each group previously failed biologic therapy.
A primary composite endpoint was clinical response at 12 weeks according to patient reported outcome and endoscopic response at 52 weeks measured with the SES-CD. A second primary endpoint was clinical response at 12 weeks by patient reported outcome combined with clinical remission on Crohn’s Disease Activity Index (CDAI) at 52 weeks.
Researchers also tracked 12 major secondary endpoints for mirikizumab vs placebo, including clinical response, endoscopic response, and clinical remission at week 12 and week 52.
Efficacy Findings
A higher percentage of participants in the mirikizumab group achieved 12-week secondary endpoints compared with placebo. In the treatment group, 32.5% reached endoscopic response vs 12.6% in the placebo group, a statistically significant difference (P <.000001 in addition achieved endoscopic remission the treatment group vs placebo at weeks>
The “treat-through” results at 52 weeks revealed that a higher proportion of the group taking mirikizumab met the co-primary endpoints compared with placebo. A total of 48.4% in the mirikizumab group vs 9.0% in the placebo group achieved endoscopic response (P <.000001 similarly a higher proportion met clinical remission on the cdai in treatment group vs placebo>
Overall, 38% of mirikizumab-treated patients vs 9% of the placebo group reached a composite endpoint of patient reported clinical response at week 12 and endoscopic response by SES-CD at week 52 (P <.000001>
Sands and colleagues also combined clinical response reported by patients at 12 weeks with CDAI findings for clinical remission at week 52. A total of 45.4% in the treatment group met the combined endpoint compared with 19.6% of the placebo group (P <.000001>
In an additional analysis, the researchers looked at this composite endpoint in patients in both groups who had failed or not failed a prior biologic for a total of 43.4% vs 12.4%, and 47.3% vs 26.5%, respectively.
“Mirikizumab demonstrated statistically significant and clinically meaningful improvements” in the study co-primary endpoints and secondary endpoints compared with placebo, the researchers concluded.
Safety Findings
Safety outcomes during the 52-week study were “consistent with the known safety profile” of mirikizumab, the researchers noted.
Treatment-emergent adverse events occurred in 78.6% of mirikizumab participants vs 73.0% of the placebo group. The most common were COVID-19, anemia, and arthralgia. Serious adverse events were reported in 10.3% of the mirikizumab group vs 17.1% of the placebo group. There were seven opportunistic infections in the treatment group, including herpes zoster and Candida, compared with none in the placebo group.
One person in the placebo cohort died of a pulmonary embolism; there were no deaths in the mirikizumab group.
People randomly assigned to placebo without a response at 12 weeks were switched over to mirikizumab. However, the findings from this group between 12 and 52 weeks were excluded from the 1-year data presented at DDW 2024, including one death from worsening Crohn’s disease during that time.
Mirikizumab looked particularly robust in this study, and it may turn out to be a critically important option for our patients, said Jordan Axelrad, MD, MPH, co-director of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City. Axelrad was not involved in this study.
Of importance, effect sizes were similar for “bio-naive and previously biologic-exposed patients,” he added.
These data “really underscore that therapies targeting IL-23 may be clinically useful for Crohn’s disease patients with prior biologic failure, representing a significant departure from our previous experience with other biologic classes,” Axelrad said.
The study was funded by Eli Lilly and Company. Sands is a consultant and receives grant funding from Lilly. Axelrad had no relevant disclosures.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and critical care. Follow Damian on Twitter: @MedReporter.
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