- Dignass A, et al. Sustained symptom control with mirikizumab in patients with moderately to severely active ulcerative colitis in the LUCENT-2 maintenance trial. MP242, UEG Week 2022, Vienna, Austria, 8–11 October.
In the LUCENT-1 induction trial (NCT03518086), mirikizumab demonstrated significant efficacy in the treatment of patients with moderately-to-severely active ulcerative colitis after 12 weeks1. Prof. Axel Dignass (Agaplesion Markus Hospital, Germany) presented the maintenance data of the phase 3 LUCENT-2 study (NCT03524092) on maintenance over 40 weeks.
The new study randomised 544 responders of the LUCENT-1 trial 1:2 to placebo or maintenance treatment of 200 mg mirikizumab every 4 weeks. Among the baseline disease characteristics were a mean disease duration between 6.7 and 6.9 years, mean modified Mayo score of around 6.5, median bowel urgency severity of 6.0, and mean abdominal pain of 4.9 and 5.3 on a numeric rating scale. More than one-third of the patients had prior failure to biologic or tofacitinib treatment.
After 40 weeks of maintenance, stool frequency remission was attained by 75.1% in the mirikizumab arm compared with 44.7% on placebo (P<0.001). Rectal bleeding remission was achieved by 79.7% in the intervention arm versus 49.7% on placebo (P<0.001). Symptomatic remission, consisting of stool frequency plus rectal bleeding remission, was observed in 71.0% on the study drug and 39.7% on placebo (P<0.001).
Furthermore, 69.7% versus 38.4% had a stable maintenance of symptomatic remission at week 40 (P<0.001), also favoring the group that had a total of 52 weeks of continuous mirikizumab therapy. As for bowel urgency remission, patients on mirikizumab profited of an additional 13.6 percentage points in the first 2 months of maintenance and at week 40: 42.9% on mirikizumab maintained bowel urgency remission compared with 25.0% on placebo (P<0.001). An improvement of ≥30% in abdominal pain was found in 76.2% and 47.2% of mirikizumab and placebo at week 40.
The study authors summarised that sustained maintenance of remission of ulcerative colitis symptoms, including rectal bleeding, stool frequency, bowel urgency, and abdominal pain was observed in mirikizumab-treated patients compared with placebo through 40 weeks.