Patients Receiving Mirikizumab Report Improved Ulcerative Colitis Symptoms

Patients receiving treatment with mirikizumab had an improved perspective of the severity of their ulcerative colitis.

Patient-reported outcomes improve following treatment with mirikizumab for moderate to severe active ulcerative colitis (UC), according to study results presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2022 conference, held from December 5 to 7, 2022, in Orlando, Florida.

The LUCENT-1 and LUCENT-2 trials (ClinicalTrials.gov Identifier: NCT03518086 and NCT03524092, respectively) demonstrated the safety and efficacy of mirikizumab, an anti-IL23p19 antibody therapy, in the setting of moderate to severe active UC.

The current study was a posthoc analysis of patient-reported outcomes from the LUCENT trials. In LUCENT-1, patients (N=1281) with moderately to severely active UC were randomly assigned 3:1 to receive 300 mg intravenous mirikizumab or placebo every 4 weeks. Patients who achieved clinical response at week 12 (n=544) were rerandomly assigned 2:1 for the LUCENT-2 trial to receive 200 mg subcutaneous mirikizumab or placebo every 4 weeks for 40 weeks. In this analysis, the change in Patient’s Global Rating of Severity (PGRS) scale and Patient’s Global Rating of Change (PGRC) scores from baseline were evaluated using a modified baseline-observation-carried-forward approach.

At baseline, the mean (SD) PGRS scores were 4.24[0.82] points among the mirikizumab cohort and 4.28[0.81] points among the placebo group.

Starting at week 2, the least-squares mean difference (LSMD) in PGRS scores from baseline were significantly greater among mirikizumab recipients compared with placebo (LSMD, -0.39 vs -0.28; P =.03) and became more pronounced at week 12 (LSMD, -1.16 vs -0.69; P <.001), respectively.

In LUCENT-2, after 52 weeks of treatment, the mirikizumab recipients continued to report significantly greater changes in PGRS scores (LSMD, -2.04) comapred with placebo (LSMD, -1.39; P <.001).

Similarly, PGRC scores were significantly lower for the mirikizumab cohort compared with placebo at weeks 4 (mean, 2.8 vs 3.2; P <.001), 12 (mean, 2.3 vs 3.0; P <.001), and 52 (mean, 1.6 vs 1.9; P =.009), respectively.

“Mirikizumab treatment in patients with moderately-to-severely active UC significantly improved patient self-assessment of disease symptoms,” the study authors wrote. “Improvement was achieved as early as Week 2 for PGRS and Week 4 for PGRC and improvements were sustained through Week 52. These data support improvement in patients’ health status from a patient perspective.”

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:

Travis S, Wu J, Sapin C, Hunter Gibble T, Hibi T. Mirikizumab improves patient assessments of disease severity and change in disease activity in patients with moderately-to-severely active ulcerative colitis. Abstract presented at: AIBD 2022; December 5-7, 2022; Orlando, FL. Abstract 120.