Mirikizumab Eases Bowel Urgency in Crohn’s Disease

TOPLINE:

Mirikizumab, an interleukin-23p19 inhibitor, provided early and sustained relief of bowel urgency — an underrecognized and debilitating symptom — in patients with moderate-to-severe Crohn’s disease.

METHODOLOGY:

• This analysis, part of the phase 3 VIVID-1 trial, evaluated bowel urgency outcomes in adult patients with moderate-to-severe Crohn’s disease who were unresponsive or intolerant to conventional or biologic therapies and were randomized to receive either mirikizumab or placebo.
• Mirikizumab was administered at 900 mg intravenously every 4 weeks for induction (weeks 0-12), followed by 300 mg subcutaneously every 4 weeks for maintenance through week 52.
• Bowel urgency was measured at baseline and every 4 weeks using the validated Urgency Numeric Rating Scale (NRS; score range, 0 [no urgency] to 10 [worst possible urgency]).
• The proportion of participants with baseline Urgency NRS scores ≥ 3 and ≥ 6 who achieved clinically meaningful improvement (≥ 3-point reduction in Urgency NRS) and remission (Urgency NRS ≤ 2) was determined.

TAKEAWAY:

• Of 778 patients analyzed, 579 received mirikizumab (mean age, 36 years; 42.7% women) and 199 received placebo (mean age, 36.3 years; 40.7% women).
• At baseline, 94.2% had an Urgency NRS ≥ 3 and 65.9% ≥ 6; Crohn’s disease activity index and abdominal pain positively correlated with bowel urgency.
• Mirikizumab significantly improved bowel urgency compared with placebo, with effects noted as early as week 6 (P < .05) and sustained through week 52.
• Among those with Urgency NRS ≥ 3 at baseline, mirikizumab significantly increased rates of both clinically meaningful improvement and remission at weeks 12 and 52 compared with placebo. However, differences were not significant for those with baseline Urgency NRS ≥ 6.
• Achieving clinically meaningful improvement in bowel urgency at week 12 correlated with better clinical and endoscopic outcomes at weeks 12 and 52.

IN PRACTICE:

“This study highlights the importance of assessing [bowel urgency] in [Crohn’s disease] and provides valuable information for [healthcare providers] when considering appropriate [bowel urgency] management, regardless of disease activity control,” the authors wrote.

SOURCE:

This study was led by Vipul Jairath and Geert D’Haens, University Hospital, London, Ontario, Canada, and Amsterdam University Medical Centers, Amsterdam, Netherlands, respectively. It was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The Urgency NRS score is subjective and potentially varies over time and between participants. Most participants were White or Asian individuals, limiting generalizability. Real-world clinical visit frequency may differ from that in trial settings.

DISCLOSURES:

This study was funded by Eli Lilly and Company. Seven authors were employees and shareholders of Eli Lilly and Company. Other authors reported financial disclosures (eg, fees, grants, research support, and consulting/advisory roles) with multiple pharmaceutical companies, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.