Sands BE, Peyrin-Biroulet L, Kierkus J, et al. - Treating moderate-to-severe Crohn disease (CD) using mirikizumab (a humanized monoclonal antibody targeting IL-23p19) effectively conferred endoscopic response post-12 weeks of treatment and this therapeutic agent showed a durable efficacy to Week 52.

• This study included patients with moderate-to-severe CD who were randomly assigned (N=191) to receive placebo (PBO), 200, 600, or 1000mg mirikizumab, given intravenously (IV) every 4 weeks (Q4W).

• Re-randomization of mirikizumab-benefited patients (Re-randomized Maintenance Cohort) to continue their induction IV treatment (IV-C) or receive 300mg mirikizumab subcutaneously (SC) Q4W was done.

• All mirikizumab groups showed significantly higher endoscopic response at Week 12 vs PBO.

• At Week 52, endoscopic response was 58.5% and 58.7% in the IV-C and SC groups, respectively.

• Similar frequencies of adverse events (AE) were observed in mirikizumab and PBO groups.

• Across all groups, similar frequencies of TEAEs were noted through Week 52.

• In the Non-randomized Maintenance Cohort (including endoscopic non-improvers and PBO patients who received 1000mg mirikizumab IV from Week 12), there were higher frequencies of serious AE and discontinuations due to AE.