Mirikizumab is associated with improvements in bowel urgency and quality of life in moderately-to-severely active ulcerative colitis: 28-week phase 3b results from the LUCENT-URGE trial.
7 affiliations
- 1Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, United States.
- 2CHU de Bordeaux, Centre Medico-Chirurgical Magellan, Hospital Haut-Lévêque, Gastroenterology Department, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.
- 3Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
- 4United Medical Doctors, Gastroenterology, Murrieta, CA, United States.
- 5Eli Lilly and Company, Indianapolis, IN, United States.
- 6IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
- 7Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Abstract
Background
Mirikizumab, an anti-interleukin-23p19 monoclonal antibody approved for ulcerative colitis (UC) and Crohn's disease, was evaluated in LUCENT-URGE (NCT05767021), a phase 3b, open-label study assessing its effect on bowel urgency (BU) through week (W)28 in adults with moderately-to-severely active UC, using novel BU measures and validated quality of life (QoL) instruments.Methods
Patients with UC experiencing BU (baseline severity ≥3 on the urgency numeric rating scale [UNRS]) received 300 mg mirikizumab intravenously at W0, W4, and W8, then 200 mg subcutaneously at W12 and every 4 weeks up to W24. Improvements in QoL and patient-reported outcomes were assessed from baseline to W12 and W28.Results
Among 172 patients, 58.1% achieved clinically meaningful improvement (≥3-point reduction in UNRS), and 37.8% reached BU remission (rounded UNRS ≤ 1) by W28. Inflammatory Bowel Disease Questionnaire (IBDQ) scores improved by 56.4 points, with 52.3% of patients achieving IBDQ-remission (IBDQ ≥ 170) and 65.7% achieving IBDQ-response (≥16-point increase) at W28. Absorbent product use for BU dropped from 55.1% at baseline to 29.6% at W28. Patients reporting no sexual activity avoidance (SAA) due to UC symptoms rose from 21.1% to 51.4%. Activity impairment, Wexner Incontinence Score, and anxiety symptoms also showed improvements.Conclusion
The majority of mirikizumab-treated patients achieved clinically meaningful BU improvement over 28 weeks. In addition to QoL improvement, patients experienced reduced disruption of daily activities, with meaningful reductions in SAA and use of protective aids due to BU. Achieving BU remission or clinically meaningful improvement with mirikizumab was associated with improvements in patients' relevant UC symptoms and overall QoL.
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BibTeX
@article{long2026mirikizumab,
title = {{Mirikizumab is associated with improvements in bowel urgency and quality of life in moderately-to-severely active ulcerative colitis: 28-week phase 3b results from the LUCENT-URGE trial.}},
author = {Millie Long and David Laharie and Gerhard Rogler and Seyedehsan Navabi and Aisha Vadhariya and William J Eastman and Tian Tian and Alison Potts Bleakman and Alessandro Armuzzi},
journal = {Crohn's \& colitis 360},
year = {2026},
month = sep,
doi = {10.1093/crocol/otag107},
url = {https://europepmc.org/article/MED/42927097},
note = {CC BY},
}
RIS
TY - JOUR
TI - Mirikizumab is associated with improvements in bowel urgency and quality of life in moderately-to-severely active ulcerative colitis: 28-week phase 3b results from the LUCENT-URGE trial.
AU - Millie Long
AU - David Laharie
AU - Gerhard Rogler
AU - Seyedehsan Navabi
AU - Aisha Vadhariya
AU - William J Eastman
AU - Tian Tian
AU - Alison Potts Bleakman
AU - Alessandro Armuzzi
PY - 2026
DA - 2026/09/24
JO - Crohn's & colitis 360
DO - 10.1093/crocol/otag107
UR - https://europepmc.org/article/MED/42927097
AB - Background Mirikizumab, an anti-interleukin-23p19 monoclonal antibody approved for ulcerative colitis (UC) and Crohn's disease, was evaluated in LUCENT-URGE (NCT05767021), a phase 3b, open-label study assessing its effect on bowel urgency (BU) through week (W)28 in adults with moderately-to-severely active UC, using novel BU measures and validated quality of life (QoL) instruments.Methods Patients with UC experiencing BU (baseline severity ≥3 on the urgency numeric rating scale [UNRS]) received 300 mg mirikizumab intravenously at W0, W4, and W8, then 200 mg subcutaneously at W12 and every 4 weeks up to W24. Improvements in QoL and patient-reported outcomes were assessed from baseline to W12 and W28.Results Among 172 patients, 58.1% achieved clinically meaningful improvement (≥3-point reduction in UNRS), and 37.8% reached BU remission (rounded UNRS ≤ 1) by W28. Inflammatory Bowel Disease Questionnaire (IBDQ) scores improved by 56.4 points, with 52.3% of patients achieving IBDQ-remission (IBDQ ≥ 170) and 65.7% achieving IBDQ-response (≥16-point increase) at W28. Absorbent product use for BU dropped from 55.1% at baseline to 29.6% at W28. Patients reporting no sexual activity avoidance (SAA) due to UC symptoms rose from 21.1% to 51.4%. Activity impairment, Wexner Incontinence Score, and anxiety symptoms also showed improvements.Conclusion The majority of mirikizumab-treated patients achieved clinically meaningful BU improvement over 28 weeks. In addition to QoL improvement, patients experienced reduced disruption of daily activities, with meaningful reductions in SAA and use of protective aids due to BU. Achieving BU remission or clinically meaningful improvement with mirikizumab was associated with improvements in patients' relevant UC symptoms and overall QoL.
SN - 2631-827X
ER -