Mirikizumab-mrkz

(Omvoh®)

Omvoh®

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Drug updated on 4/16/2024

Dosage FormInjection (intravenous; 300 mg/15 mL [20 mg/mL] in a single-dose vial, subcutaneous; 100 mg/mL in a single-dose prefilled vial)
Drug ClassInterleukin-23 antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Summary
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  • 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 TitleYearSource
Omvoh (mirikizumab-mrkz) Prescribing Information.2023Eli Lilly

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Mirikizumab as induction and maintenance therapy for ulcerative colitis.
1,162Subjects
F: 40%
M: 60%
2023The 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%
2023Journal 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 TitleYearSource
A practical guide to the use of mirikizumab.2023The American Journal of Gastroenterology