This VIVID-1 phase 3 study, presented at the American College of Gastroenterology, evaluated the efficacy of mirikizumab, an anti-IL-23p19 monoclonal antibody, compared to placebo and ustekinumab in patients with moderate-to-severe Crohn’s disease (CD). This analysis focuses on mirikizumab’s efficacy across different baseline CD locations (ileal, colonic, and ileocolonic) as assessed by endoscopy.

In this study, patients were randomized to receive mirikizumab (N=579), ustekinumab (N=287), or placebo (N=199). Mirikizumab was administered at baseline, week 4, and week 8, followed by maintenance dosing every 4 weeks from week 12 to week 52. The primary endpoints included clinical remission and endoscopic response at week 52, assessed via a combination of patient-reported clinical response and Crohn’s Disease Activity Index (CDAI) clinical remission. Additional endpoints included CDAI clinical remission, endoscopic response, and endoscopic remission at week 12.

The study found that mirikizumab met both primary endpoints compared to placebo in patients with colonic and ileocolonic CD (p<0.0001). Specifically, greater proportions of mirikizumab-treated patients in these groups achieved clinical and endoscopic remission by week 12. Although mirikizumab also showed higher response rates than placebo in patients with ileal CD, the differences were not statistically significant, likely due to the small sample size in this subgroup. Overall, mirikizumab demonstrated efficacy in both symptom improvement and endoscopic outcomes across most disease locations, with a particularly strong effect in colonic and ileocolonic CD.

These results align with VIVID-1’s primary findings, supporting mirikizumab as an effective treatment for symptomatic and endoscopic improvement in moderate-to-severe CD. However, further studies are warranted to explore its effects specifically in patients with ileal-only CD, given the limited sample size, the investigators concluded.

Reference
Barnes E, Bossuyt P, Ferrante M, et al. Efficacy of mirikizumab by baseline disease location in moderately to severely active Crohn’s disease: results of the phase 3 VIVID-1 study. Presented at: American College of Gastroenterology. October 25 – 30, 2024; Philadelphia, PA.