Takeaway
- Mirikizumab induces clinical remission, clinical response, and endoscopic improvement at rates greater than placebo after 12 weeks among patients with ulcerative colitis (UC) in a dose-ranging phase 2 trial.
Why this matters
- The study is the first to demonstrate clinical benefit from a monoclonal p19-directed IL23 antibody in treating UC.
Study design
- Researchers randomly assigned patients with moderate to severe UC to receive mirikizumab in 600 mg fixed doses or in 50 mg or 200 mg exposure-based doses or placebo (n=63) at weeks 0, 4, and 8.
- Clinical responders at week 12 were randomly assigned to receive maintenance 200 mg treatment either every 4 weeks (n=47) or every 12 weeks (n=46).
- Funding: Eli Lilly and Company.
Key results
- Clinical remission occurred by week 12 in patients receiving mirikizumab 50 mg (15.9%; P=.066), 200 mg (22.6%; P=.004), and 600 mg (11.5%; P=.142) vs placebo (4.8%).
- Clinical response occurred in patients receiving mirikizumab 50 mg (41.3%; P=.014), 200 mg (59.7%; P=.001), and 600 mg (49.2%; P=.001) at rates greater than placebo (20.6%).
- Clinical remission rates at week 52 were 46.8% and 37.0% in patients receiving 200 mg maintenance mirikizumab every 4 and 12 weeks, respectively.
Limitations
- Small sample size.
- More studies needed to determine optimal dosing to induce remission.
References
References
