Combined bowel urgency, clinical outcomes, and quality of life improvement in mirikizumab-treated ulcerative colitis: a step toward comprehensive disease management.

BACKGROUND: With increasing emphasis on patient-centric care, treatment goals for ulcerative colitis (UC) now include bowel urgency (BU), stool frequency, and rectal bleeding (RB) resolution, enhancement of overall well-being, and endoscopic remission (ER). This analysis evaluated the impact of adding BU improvement to clinical remission, defined by the modified Mayo score (RB, stool frequency, ER), on quality of life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ). The effect of mirikizumab on achieving combined clinical, BU, and IBDQ remissions was also evaluated in the LUCENT-1 and -2 trials.

METHODS: In LUCENT-1, patients were randomized 3:1 (mirikizumab to placebo) every 4 weeks. At Week 12, mirikizumab responders were re-randomized 2:1 (mirikizumab to placebo) for 40 additional weeks in LUCENT-2. BU improvement was assessed using clinically meaningful improvement (Urgency Numeric Rating Scale [UNRS] ≥3-point change) and BU remission (UNRS = 0 or 1). The impact of mirikizumab on achieving single and combined outcomes was determined at Weeks 12 and 52.

RESULTS: Significant IBDQ improvement at both timepoints (P ≤ .01) was observed by achieving both BU improvement and clinical remission versus clinical remission alone. Significantly more mirikizumab-treated patients achieved single and combined endpoints of clinical, BU, and IBDQ remissions versus placebo (P ≤ .05).

CONCLUSIONS: The addition of BU improvement in patients who had already attained clinical response or remission is associated with greater quality of life. Mirikizumab delivered comprehensive benefit for patients with UC by relieving BU symptoms, resolving endoscopic inflammation, and enhancing overall well-being concurrently.