General Information

Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist.

Omvoh is specifically indicated for the treatment of moderate to severe ulcerative colitis in adults.

Dosing/Administration

Omvoh is supplied as an injection for intravenous or subcutaneous use

The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations. For that reason, recommended evaluations and immunizations prior to treatment initiation include:

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment.
• Obtain liver enzymes and bilirubin levels prior to initiating treatment.
• Complete all age-appropriate vaccinations according to current immunization guidelines.

Recommended dosages:

Mechanism of Action

Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation. Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.

Side Effects

Adverse effects associated with the use of Omvoh may include, but are not limited to, the following:

Induction: upper respiratory tract infections and arthralgia

Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

Clinical Trial Results

The FDA approval of Omvah was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.

After 12 weeks of treatment with Omvoh, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, Omvoh demonstrated consistent efficacy across subgroups, with 51% of all patients and 45% of patients who failed prior treatment with a biologic or Janus kinase inhibitor (JAKi) achieving clinical remission at one year compared to placebo (27% and 15%, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, nearly all patients (99%) who achieved clinical remission at one year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least three months prior to the end of the 52-week assessment. Among those who achieved clinical remission at 12 weeks, approximately two-thirds (66%) of patients maintained clinical remission through one year of continuous treatment compared to placebo (40%).

Rapid improvement of symptoms, such as rectal bleeding and stool frequency, were observed as early as three weeks in patients treated with Omvoh. The LUCENT trials used the patient-centric, Urgency Numeric Rating Scale (NRS) of 0-10, with zero being no bowel urgency and 10 being worst possible bowel urgency. At baseline, patients had a median Urgency NRS weekly average score of 7. Among patients who had an Urgency NRS weekly average score ≥3 at baseline and responded to induction therapy with Omvoh, a significantly greater proportion of patients (39%) treated with Omvoh achieved a weekly average score of 0 to 1 at one year, compared to placebo (23%).