# Impact of mirikizumab on patient-reported outcomes and quality of life in patients with Crohn’s disease: results from the phase 2 SERENITY study

## TL;DR

Mirikizumab improves quality of life and reduces disease severity in Crohn’s disease patients over a long-term period.

## Contribution

Demonstrates sustained quality of life improvements with mirikizumab in Crohn’s disease patients through week 104.

## Key findings

- Mirikizumab groups showed improved quality of life scores compared to placebo at week 12.
- Improvements in patient-reported outcomes were sustained through week 52 and week 104.
- Treatment was associated with reduced disease severity as reported by patients.

## Abstract

Mirikizumab is an anti-IL23p19 antibody that has shown efficacy in treating moderately to severely active Crohn’s disease in a phase 2 study. We studied mirikizumab’s impact on quality of life in these patients.

Patients (N = 191) were randomized using a 2:1:1:2 allocation across 4 treatment arms (placebo, 200 mg, 600 mg, or 1000 mg mirikizumab, administered intravenously every 4 weeks [week 0, week 4, and week 8]). Patients who received mirikizumab and achieved ≥1-point improvement in Simple Endoscopic Score for Crohn’s Disease at week 12 were rerandomized into double-blind maintenance to continue treatment with either intravenous assignment or 300 mg mirikizumab subcutaneous every 4 weeks to week 52. Non-improvers or placebo patients received 1000 mg mirikizumab until week 52. Patients with clinical benefit from the maintenance period received 300 mg subcutaneously to week 104. Quality of life and patient-reported outcomes were evaluated with the Inflammatory Bowel Disease Questionnaire, 36-Item Short-Form Health Survey Mental Component Summary and Physical Component Summary, Patient’s Global Rating of Severity, and Abdominal Pain Numeric Rating Scale. Quality of life measures were evaluated up to week 104 and analyzed with a mixed model for repeated measures up to week 12 and descriptively afterward.

At week 12, all mirikizumab groups had improved quality of life and patient-reported outcome scores compared to placebo. These improvements were sustained through week 52 and week 104.

Treatment with mirikizumab was associated with significantly improved quality of life and patient-reported disease severity sustained through week 104 in patients with moderately-to-severely active Crohn’s disease in this phase 2 study (NCT02891226).