Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous; 300 mg/15 mL [20 mg/mL] in a single-dose vial, subcutaneous; 100 mg/mL in a single-dose prefilled vial) |
| Drug Class | Interleukin-23 antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Summary
- Mirikizumab-mrkz (Omvoh) is recommended for adults with moderately to severely active ulcerative colitis, demonstrating significant efficacy in both the induction and maintenance phases of treatment.
- Two randomized controlled studies illustrated that a higher percentage of individuals achieved clinical remission by week 12 with mirikizumab (24.2%) compared to placebo (13.3%), with the rate increasing to 49.9% in the mirikizumab group by week 40.
- Treatment with mirikizumab resulted in significantly more individuals achieving histological improvement, histological remission, endoscopic remission, histological-endoscopic mucosal improvement, and histological-endoscopic mucosal remission when compared to placebo at both week 12 and week 40.
- The effectiveness of mirikizumab spans across various patient subgroups, encompassing those who had not responded to previous biologic/tofacitinib therapy, indicating its potential utility across diverse patient profiles.
- Adverse events more commonly associated with mirikizumab than with placebo included nasopharyngitis and arthralgia. Additionally, there was an increased risk profile for opportunistic infections like herpes zoster and specific cancers, including colorectal cancer, among some individuals treated with this drug.
- Predictors for achieving positive outcomes with this medication include lower baseline disease activity, female sex, and the absence of immunomodulator use at baseline. On the other hand, negative predictors such as corticosteroid use or longer disease duration might require careful consideration to manage treatment outcomes effectively.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Omvoh (mirikizumab-mrkz) Prescribing Information. | 2023 | Eli Lilly |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Mirikizumab as induction and maintenance therapy for ulcerative colitis. | 1,162Subjects F: 40% M: 60% | 2023 | The New England Journal of Medicine |
| Resolving histological inflammation in ulcerative colitis with mirikizumab in the LUCENT induction and maintenance trial programmes. | 1,177Subjects F: 40% M: 60% | 2023 | Journal of Crohn's & Colitis |
Sex Distribution:
F:40%
M:60%
1162Subjects
Year:
2023
Source:The New England Journal of Medicine
Sex Distribution:
F:40%
M:60%
1177Subjects
Year:
2023
Source:Journal of Crohn's & Colitis
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| A practical guide to the use of mirikizumab. | 2023 | The American Journal of Gastroenterology |