Long-term Benefits of Mirikizumab on Patient-Reported Outcomes in Individuals with Crohn's Disease: 2-Year Results from the VIVID-2 Extension Study.

Background

Mirikizumab, an anti-IL-23p19 monoclonal antibody, has demonstrated clinical efficacy in Crohn's disease (CD), improving symptoms and quality of life (QoL) over one year in the VIVID-1 trial. This analysis from the VIVID-2 open-label extension evaluated its long-term impact on CD symptoms and QoL at two years.

Methods

Patients from VIVID-1 with an endoscopic response continued mirikizumab (300 mg subcutaneous) in VIVID-2. Endoscopic non-responders at 52 weeks underwent re-induction, then maintenance therapy. QoL was assessed at Weeks 64 and/or 104 using the Inflammatory Bowel Disease Questionnaire (IBDQ), EQ-5D-5L visual analog scale (VAS), and work productivity by Work Productivity and Activity Impairment: Crohn's Disease (WPAI:CD) questionnaire. Other patient-reported outcomes (PRO) assessed were fatigue (FACIT-Fatigue), abdominal pain (AP), stool frequency (SF), and clinical remission by PRO (AP ≤1 and SF ≤3, no worsening from baseline). Missing data were handled with modified non-responder imputation for categorical outcomes, and baseline observation carried forward for continuous outcomes. Analysis of covariance was used to estimate mean changes from baseline.

Results

At 104 weeks, 85.0% of VIVID-1 endoscopic responders and 72.6% endoscopic non-responders achieved IBDQ response, while 71.3% endoscopic responders and 60.8% endoscopic non-responders achieved IBDQ remission. By Week 64, EQ-5D-5L VAS scores improved by 22-27 points, WPAI decreased by 14-34 points, and >60% patients achieved meaningful improvement in fatigue. Approximately 75% responders and 54% non-responders achieved clinical remission by PRO at two years.

Conclusion

Long-term mirikizumab treatment led to sustained QoL improvements and reduced symptoms in patients with CD, regardless of their endoscopic response status.