Mirikizumab in moderately to severely active ulcerative colitis: a profile of its use

Mirikizumab (mirikizumab-mrkz; Omvoh^TM), a first-in-class selective monoclonal antibody against the p19 subunit of interleukin (IL)-23, extends the treatments available for patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy, a biologic treatment or Janus kinase inhibitor. In placebo-controlled phase 3 clinical trials in patients with moderately to severely active ulcerative colitis, induction therapy with intravenous mirikizumab and maintenance therapy with subcutaneous mirikizumab significantly increased the proportion of patients who achieved clinical remission at week 12 and week 40 (a total of 52 weeks of mirikizumab exposure) compared with placebo, and also provided significant improvements in clinical, symptomatic and histologic-endoscopic outcomes. In a long-term extension study, more than half of patients who had a treatment response at the end of the maintenance trial were in clinical remission (nonresponder imputation) after an additional 52 weeks of mirikizumab (a total of 104 weeks of mirikizumab exposure). Mirikizumab was generally well tolerated, with the most common adverse events in the mirikizumab group being nasopharyngitis and headache in the induction trial and nasopharyngitis, arthralgia, injection site-related pain, headache, rash and pyrexia in the maintenance trial. No new safety signals were reported in the long-term extension study.