Mirikizumab- a monoclonal antibody, recently received FDA approval to treat moderate to severely active ulcerative colitis in adults. The efficacy and safety were evaluated in two randomized, double-blind, placebo-controlled trials. The major benefits of the drug include reduced rectal bleeding, reduced stool frequency and bowel urgency.
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Mechanism of action:
Mirikizumab is a humanized IgG4 monoclonal antibody that blocks the action of IL-23 (a proinflammatory cytokine).
Throughout the trial, the drug consistently reduced the severity of the disease. It also improved response to anti TNF treatment, demonstrating the beneficial effects of IL-
23 inhibition.
Dosage and administration:
- Induction dose: 300 mg administered as an intravenous infusion over 30 minutes, at weeks 0, 4 and 8.
- Maintenance dose: 200 mg administered as a subcutaneous injection (2consecutive injections of 100 mg each), given at week 12 and every 4 weeks thereafter.
Precautions:
- Hypersensitivity reactions (anaphylaxis during infusion, mucocutaneous erythema, pruritus during induction)
- Increased risk of infection
- Hepatotoxicity
- Live vaccines
Adverse reactions:
- Upper respiratory tract infections
- Arthralgia, rash
- Headache
- Herpes viral infection, worsening of active TB infection
- Hypersensitivity reactions.
References:
https://www.accessdata.fda.gov/drugsatfda_docs/label/20231761279s000lbl.pdf
https://jpet.aspetjournals.org/content/jpet/early/2023/09/15/jpet.122.001512.full.pdf
