Mirikizumab Provides Sustained Symptom Control in Ulcerative Colitis

Maintenance therapy with mirikizumab results in sustained control of ulcerative colitis symptoms.

Mirikizumab maintenance therapy was found to provide sustained symptom control among patients with moderate to severe ulcerative colitis (UC), according to study results presented at the American College of Gastroenterology (ACG) 2022 Annual Meeting, held from October 21 to 26, 2022, in Charlotte, North Carolina, and virtually.

The LUCENT-2 trial was the 40-week maintenance phase trial that followed the phase 3, multicenter, randomized, double-blind, parallel, placebo-controlled 12-week induction study (LUCENT-1) of mirikizumab for the treatment of UC. Patients (N=544) with moderate to severe UC who achieved a clinical response from 300 mg mirikizumab dosed every 4 weeks for 12 weeks in LUCENT-1 were rerandomly assigned in a 2:1 ratio to receive 200 mg subcutaneous mirikizumab (n=365) or placebo (n=179) every 4 weeks for 40 weeks. The outcomes included stool frequency remission, which was defined as a score of 0 or 1 with at least a 1-point reduction from baseline; bowel urgency remission, defined as a numeric rating scale (NRS) score of 0 or 1 with a score of at least 3 at baseline; rectal bleeding remission, defined as a score of 0; symptomatic remission, defined as both stool frequency and rectal bleeding remission; and stable maintenance of symptomatic remission, defined as symptomatic remission for 7 or more visits from week 4.

Miri [mirikizumab] provides sustained control of UC symptoms including BU [bowel urgency], RB [rectal bleeding], and SF [stool frequency] compared to PBO [placebo] in pts [patients] with moderately to severely active UC.

At week 40, the mirikizumab group had a higher rate of stool frequency remission (risk difference [RD], 29.6; 95% CI, 21.2-38.0), rectal bleeding remission (RD, 29.1; 95% CI, 20.8-37.4), bowel urgency remission (RD, 18.1; 95% CI, 9.8-26.4), symptomatic remission (RD, 30.2; 95% CI, 21.9-38.6), and stable maintenance of symptomatic remission (RD, 31.0; 95% CI, 20.7-41.2) compared with placebo.

In addition, more mirikizumab recipients reported at least 30% reduction in abdominal pain NRS scores (RD, 27.4; 95% CI, 18.3-36.4).

This study was limited by not including a safety analysis.

“Miri [mirikizumab] provides sustained control of UC symptoms including BU [bowel urgency], RB [rectal bleeding], and SF [stool frequency] compared to PBO [placebo] in pts [patients] with moderately to severely active UC,” the study authors wrote.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

References:

Dignass A, Danese S, Matsuoka K, et al. Sustained symptom control with mirikizumab in patients with moderately-to-severely active ulcerative colitis in the LUCENT-2 maintenance trial. Abstract presented at: ACG 2022 Annual Meeting; October 21-26, 2022; Charlotte, NC. Abstract C0401.