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Maintained symptom control with mirikizumab in UC

Presented by
Prof. Axel Dignass, Agaplesion Markus Hospital, Germany
UEGW 2022
Phase 3, LUCENT 2
Patients with moderate-to-severe ulcerative colitis (UC) demonstrated sustained symptom control after response to induction therapy with mirikizumab. Stool frequency remission and rectal bleeding remission were maintained at week 40 in over three-quarters of patients.

Mirikizumab, a monoclonal antibody against the p19 subunit of IL-23, has shown superior efficacy over placebo in patients with moderately to severely active UC in the LUCENT 1 induction trial (NCT03518086) [1–3]. Furthermore, there were positive results for the maintenance of clinical remission at week 40 in the phase 3 LUCENT 2 study (NCT03524092) [4]. Prof. Axel Dignass (Agaplesion Markus Hospital, Germany) presented a new analysis of LUCENT 2 that focussed on symptom control maintenance [1].

“This is a fairly severe patient population with UC,” Prof Dignass commented on the study cohort at baseline of LUCENT 1. Among the disease characteristics were a mean disease duration between 6.7 and 6.9 years, a mean modified Mayo score of around 6.5, a median bowel urgency severity of 6.0, and a mean abdominal pain of 4.9 and 5.3 on a numeric rating scale. “There is pancolitis seen in one-third of the patients and if you look at the endoscopic Mayo score, you see that about half of the patients had a severe activity,” Prof. Dignass further specified. More than one-third of the patients had prior failure to a biologic or tofacitinib treatment. LUCENT 2 randomised 544 responders of the LUCENT 1 trial 2:1 to maintenance treatment of 200 mg mirikizumab or placebo every 4 weeks.

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 for 71.0% of the study drug arm and 39.7% in the placebo arm (P<0.001). Furthermore, 69.7% versus 38.4% had stable symptomatic remission at week 40 of maintenance (P<0.001), also favouring the group that had a total of 52 weeks of continuous mirikizumab therapy. As for bowel urgency remission, participants on mirikizumab profited of an additional 13.6% points in the first 2 months of maintenance. At week 40, 42.9% of participants on mirikizumab maintained bowel urgency remission compared with 25.0% on placebo (P<0.001). An improvement of ≥30% from baseline in abdominal pain was found for 76.2% and 47.2% (P<0.001) in the mirikizumab and placebo arms at week 40.

“In conclusion, a greater proportion of mirikizumab-treated patients could maintain their clinical improvements looking at the patient-reported outcomes and sustained maintenance of remission in UC symptoms including rectal bleeding, stool frequency, bowel urgency, and abdominal pain,” Prof. Dignass summarised.

  1. 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, 8–11 October, Vienna, Austria.
  2. Sands BE, et al. Gastroenterology. 2022;162:495–508.
  3. D’Haens G, et al. J Crohns Colitis. 2022;16:i028–i029.
  4. Dubinsky MC, et al. Gastroenterology. 2022;162:S1393–94.

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