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Mirikizumab four-year sustained and durable efficacy and safety in ulcerative colitis: Final findings from the LUCENT-3 open-label extension study - PubMed

5 hours ago
  • #mirikizumab
  • #long-term efficacy
  • #ulcerative colitis
  • Mirikizumab, an anti-interleukin-23 monoclonal antibody, demonstrated sustained efficacy and safety over four years in patients with moderately-to-severely active ulcerative colitis (UC).
  • The LUCENT-3 open-label extension study included 868 participants, with 182 completing four years of continuous treatment, totaling 835.3 patient years of exposure.
  • At week 212, 77.7% of Week 52 Maintenance Remitters achieved clinical and corticosteroid-free remission, with high rates of endoscopic (81.3%) and histologic-endoscopic mucosal remission (66.0%).
  • Symptomatic remission was observed in 94.3% of Week 52 Maintenance Remitters, and 74.8% of Week 52 Maintenance Responders achieved bowel urgency remission.
  • Quality of life improvements were sustained, with 70% achieving IBDQ response and over 66% remission at week 212.
  • No new safety signals emerged during the long-term extension, supporting mirikizumab's safety profile.
  • Efficacy was consistent across biologic-failed and biologic-naive subgroups, indicating broad applicability.