Psoriasis: mirikizumab shows benefit in phase 2 trial

  • Reich K & al.
  • Br J Dermatol
  • 7 Feb 2019

  • curated by Brian Richardson, PhD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Investigational agent mirikizumab met its primary endpoint for patients with moderate to severe plaque psoriasis in a phase 2 randomized controlled trial (RCT).

Why this matters

  • Mirikizumab, an anti-interleukin-23 monoclonal antibody, may represent a promising new therapy option.

Key results

  • The primary objective was met (superiority to placebo for achieving ≥90% improvement in the Psoriasis Area and Severity Index [PASI90]) at week 16:
    • 0% for placebo.
    • 29.4% for mirikizumab 30 mg (P=.009 vs placebo).
    • 58.8% for mirikizumab 100 mg (P<.001 vs placebo>
    • 66.7% for mirikizumab 300 mg (P<.001 vs placebo>
  • Mirikizumab was also associated with higher rates of PASI75 and static Physician's Global Assessment compared with placebo (P<.001 for all style="list-style-type:circle;">
  • 3.8% and 1.9%, respectively, for placebo.
  • 52.9% and 37.3%, respectively, for mirikizumab 30 mg.
  • 78.4% and 70.6%, respectively, for mirikizumab 100 mg.
  • 74.5% and 68.6%, respectively, for mirikizumab 300 mg.
  • 1.3% of patients who received mirikizumab and 1.9% of patients who received placebo experienced serious adverse events.
  • Study design

    • 205 patients with moderate to severe plaque psoriasis received placebo (N=52), mirikizumab 30 mg (N=51), mirikizumab 100 mg (N=51), or mirikizumab 300 mg (N=51) at weeks 0 and 8 and were evaluated at week 16.
    • Funding: Eli Lilly and Company.

    Limitations

    • Short study duration.