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.
Long Millie M, Laharie David D, Rogler Gerhard G, Navabi Seyedehsan S et al.
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. 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. 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. 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.