Ulcerative colitis: mirikizumab shows clinical benefit in phase 2 trial

  • Sandborn WJ & al.
  • Gastroenterology
  • 4 Sep 2019

  • International Clinical Digest
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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.