Omvoh is a biologic medicine used to treat moderate to severe ulcerative colitis. Ulcerative colitis is an inflammatory bowel disease that causes inflammation in parts of the digestive tract. Common signs of ulcerative colitis are diarrhea, belly pain, blood in the stool, and weight loss. Studies have shown that some people who took Omvoh were able to achieve remission (freedom from noticeable symptoms). Some people were also able to discontinue oral steroid medicine.
Omvoh was approved in 2023 to treat moderate to severe ulcerative colitis in adults. The medicine targets interleukin (IL)-23 and contains the active ingredient mirikizumab-mrkz.
How Does Omvoh Work for Ulcerative Colitis?
Omvoh is a monoclonal antibody that reduces inflammation. It targets specific proteins that cause gut inflammation in people with ulcerative colitis.
What Should I Do Before Starting Treatment?
Your health care provider will evaluate you for tuberculosis (TB). If you have a history of latent TB (germs are in your body, but your immune system keeps them from spreading) or have active TB (germs multiply and make you sick), your health care provider may have you take medicine for TB before starting Omvoh.
Your health care provider will evaluate your liver function by performing blood work prior to starting Omvoh. Your health care provider will also periodically check your blood work during Omvoh therapy to make sure your liver stays healthy.
Your health care provider will review your vaccination record and recommend any vaccines you may need prior to starting Omvoh. Live vaccines should not be given during Omvoh therapy. Live vaccines include measles, mumps, rubella (MMR) and chickenpox.
How Do I Use Omvoh?
Omvoh is a liquid that is infused into a vein or injected under the skin. Omvoh is given once every four weeks for the first three doses as an infusion into a vein, and then once every four weeks thereafter as an injection under the skin.
The first three doses of Omvoh are given as an infusion through a vein in a health care facility. After these infusions, Omvoh is injected into the thighs or stomach area by you or a caregiver at home. A caregiver may also inject the medicine into the back of the arm. Do not inject into areas of the skin that are tender, bruised, red, or hard. Each injection should be given at a different site. Do not inject within 2 inches around your belly button. Injection into the thighs should be at least 2 inches above the knee and two inches below your groin.
Omvoh comes in two forms. The most common form is a prefilled injection device that is ready to use, so you do not need to learn how to use a syringe and needle. The medicine also comes in a prefilled syringe with a needle. In either case, if your health care provider decides you can give your injections at home, they will give you instructions and teach you how to give yourself the injection. The medicine is stored in the refrigerator. To make the injection more pleasant, it is helpful to let it warm up to room temperature before using it.
It is important to inject the medicine properly so that you get the right dose. Your prescription should come with “Instructions for Use,” which explains how to prepare and give a dose. Ask your pharmacist or other health care provider if you are unsure how to use Omvoh.
How Was Omvoh Studied?
The effect of Omvoh on disease remission was studied in people between 18 to 80 years of age with moderate to severe ulcerative colitis. People in these studies had tried other treatments first. These studies mainly looked at clinical remission (free from noticeable symptoms), steroid-free clinical remission (free from noticeable symptoms and not needing steroids), endoscopy findings, and improvements in bowel urgency (a sudden need to poop). Clinical remission was based on improvements in a stool (poop) frequency score called the Mayo score (on a scale from 0 to 12, with higher scores meaning worse disease).
The average age for people who took Omvoh was 43, and 61% were male. About 40% of people used steroid medicine to help control their disease.
What Were the Benefits?
More people showed a response to treatment with Omvoh versus a placebo (no medicine) for ulcerative colitis at 12 weeks and at 52 weeks. More people taking Omvoh had improvements in symptoms and were able to stop taking steroids. Results are provided in the tables below. Your results may differ from what was seen in clinical studies.
Clinical Remission
12 weeks | 52 weeks | |
Placebo | 13.3% | 25.1% |
Omvoh | 24.2% | 49.9% |
Steroid-Free Clinical Remission
52 weeks | |
Placebo | 21.8% |
Omvoh | 44.9% |
Noticeably Improved Endoscopy Findings
12 weeks | 52 weeks | |
Placebo | 21.1% | 29.1% |
Omvoh | 36.3% | 58.6% |
Bowel Urgency Remission
52 weeks | |
Placebo | 25% |
Omvoh | 42.9% |
What Is Its Place in Therapy?
Current treatment guidelines support the use of Omvoh as an option in adults with moderate to severe ulcerative colitis. Omvoh is considered an "intermediate efficacy" medicine by guidelines. Guidelines suggest using an intermediate efficacy or "advanced efficacy" medicine in people with or without a history of using other advanced medicines for ulcerative colitis.
How to Prevent and Manage Side Effects
The most common side effects of Omvoh include infection in the nose or throat, sore throat, or common cold symptoms; herpes viral infections; headache; joint pain; rash; and pain, itching, swelling, or redness where the needle went in your skin.
Omvoh increases your risk of infection because of how it works on your immune system. The most common infections reported in clinical studies included upper respiratory tract infections and herpes infections. Your health care provider will check you for infections and TB before you start Omvoh. To reduce the risk of infection when taking Omvoh, your health care provider will also review your vaccination record and recommend vaccines for you. It is also important to use good hygiene practices such as disinfecting surfaces, washing your hands, and avoiding touching your face. You should also avoid being in close contact with someone you know is sick and avoid large crowds. Call your health care provider right away if you have any signs of infection such as fever, chills, or a cough that doesn’t go away,
To limit headaches, be sure you are getting enough sleep, staying hydrated, exercising, and not skipping meals. Hot or cold compresses, meditation, resting in a cool, dark room, and massage may also help.
If you have joint pain, your health care provider may recommend an over-the-counter (OTC) medication such as acetaminophen.
The Omvoh Pen can cause reactions in the part of the body where you get the shot. These reactions are usually mild and include rash, swelling, redness, itching, and warmth. If you have a reaction, apply a warm or cool compress to the area for 15 to 20 minutes. Your health care provider may recommend an OTC pain reliever, such as ibuprofen, or an OTC antihistamine, like diphenhydramine, for itching.
Are There Any Reasons I Should Not Take Omvoh?
Make sure your health care provider is aware of all your current or past health conditions.
You should not take Omvoh if you have an active or latent TB infection or other type of infection that has not been adequately treated. Anyone with a serious allergic or injection-related reaction to Omvoh should not continue to use it.
You should not take Omvoh if you have serious liver problems.
You should not start Omvoh if you are not up to date with vaccines. Live vaccines should not be given during treatment.
Is There Any Cost Assistance Available?
There is a patient support program, Omvoh Together, that may help you afford Omvoh. Your health care provider will help you get started. For questions or more information, you can contact the drugmaker at 844-466-8644 or visit omvoh.lilly.com/savings-support.
