Tremfya is a biologic medicine used to treat moderate to severe ulcerative colitis. Ulcerative colitis is an inflammatory bowel disease. It causes irritation, inflammation, and ulcers in parts of the large intestine within the digestive tract. Common symptoms are diarrhea, belly pain, blood in the stool, feeling tired, and weight loss. Ulcerative colitis treatment may include medicines, changes in diet, or surgery.
How Does Tremfya Work for Ulcerative Colitis?
Tremfya is a monoclonal antibody that reduces inflammation. The main ingredient in Tremfya is a medicine called guselkumab. This medicine blocks a substance called interleukin-23 (IL-23). This substance is normally made by your body and is part of your body’s response to inflammation. Blocking IL-23 can decrease 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 Tremfya.
Your health care provider will evaluate your liver function by performing blood work prior to starting Tremfya. Your health care provider will also periodically check your blood during Tremfya 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 Tremfya. Live vaccines should not be given during Tremfya therapy. Live vaccines include measles, mumps, rubella (MMR), and chickenpox.
How Do I Use Tremfya?
Tremfya is a liquid that is infused into a vein or injected under the skin. Tremfya is given once every four weeks for the first three doses as an infusion into a vein, and then once every four or eight weeks thereafter as an injection under the skin.
The first three doses of Tremfya are given as an infusion through a vein in a health care facility. After these infusions, Tremfya is injected into the front of the thighs or stomach area by you or a caregiver at home. A caregiver may also inject the medicine into the back of the upper 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.
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 Tremfya.
How Was Tremfya Studied for Ulcerative Colitis?
Two clinical studies called QUASAR were done to see if Tremfya was safe and effective for the treatment of moderate to severe ulcerative colitis. Tremfya was compared to a placebo that contained no medicine. Most of the people in the studies did not know if they were getting Tremfya or placebo.
The first study was an induction study in 701 people who were 18 to 79 years of age. Tremfya or placebo was given as an infusion into a vein at the beginning of the study (week 0), week 4, and week 8. The average age of people in the study was 39, and 43% were female. Most (72%) were White, 21% were Asian, 1% were Black or African American, and less than 1% were American Indian or Alaska Native. People in these studies had tried other treatments first. About 43% of people used steroid medicine to help control their disease. The main goal of the study was clinical remission (free from noticeable symptoms) at 12 weeks.
At the end of the induction study, people who had a clinical response were entered into a longer study where people used Tremfya in two different doses or placebo for up to 44 weeks. This measured how well Tremfya worked for maintenance therapy for ulcerative colitis.
These studies looked at clinical remission (free from noticeable symptoms) at 12 weeks (induction) and 44 weeks (maintenance). They also looked at steroid-free clinical remission (free from noticeable symptoms and not needing steroids), endoscopy findings, stool (poop) frequency, and bloody stools. Clinical remission was based on improvements in a stool frequency score called the Mayo score (on a scale from 0 to 12, with higher scores meaning worse disease).
What Benefits Were Seen With Tremfya?
People in the studies who used Tremfya during the first 12-week period had significantly higher rates of remission than those who used the placebo. About 23% of people who used Tremfya, compared to 8% of those who used the placebo, reached remission.
Similarly, during the maintenance period, people who used Tremfya had a significantly higher rate of remission than those who used the placebo. About 45% to 50% of people who used Tremfya had clinical remission at week 44, compared to 19% of people who used the placebo.
People taking Tremfya had decreases in rectal bleeding and stool frequency as early as week 4 compared to the placebo. More people taking Tremfya had improvements in symptoms and were able to stop taking steroids compared to the placebo.
Your results may differ from what was seen in clinical studies.
How Long Does It Take Tremfya to Work?
If Tremfya is working, your symptoms will start to improve over the first four weeks.
Do not stop using this or any other medicines for ulcerative colitis without talking to your health care provider first, even if your symptoms have gotten better. Your symptoms may get worse again if you stop or change any of your medicines.
Tell your health care provider if your symptoms do not seem to be getting better after about 12 weeks of using Tremfya. Your health care provider may discuss other options for treating this condition.
What Is Its Place in Therapy?
Current treatment guidelines support the use of Tremfya as an option in adults with moderate to severe ulcerative colitis. Tremfya is considered an "intermediate to higher efficacy" medicine by guidelines. Guidelines suggest using an intermediate-efficacy or higher-efficacy medicine in people with or without a history of using other advanced medicines for ulcerative colitis.
What Can I Do to Manage Side Effects?
The most common side effects of Tremfya for ulcerative colitis are infection, skin reactions from the needle, and joint pain.
Tremfya 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, stomach flu, fungal infections, and herpes infections. Your health care provider may check you for infections and TB before you start Tremfya. To reduce the risk of infection when taking Tremfya, your health care provider may 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, a cough that doesn’t go away, or painful urination. Your health care provider may stop Tremfya until your infection is gone.
To limit injection site reactions such as redness, pain, swelling, and/or bruising where you get the shot, inject the medicine into a different part of the body each time, which is called rotating the injection site. For example, Tremfya can be injected into the front of the thighs, lower stomach area, or back of the upper arms. Do not inject Tremfya into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
If you have joint pain, your health care provider may recommend an over-the-counter (OTC) pain medicine such as acetaminophen.
Tremfya can also cause allergic reactions, which can be serious. Talk to your health care about your allergies.
Liver damage, also called hepatotoxicity, can happen when taking Tremfya. Your health care provider will monitor your liver with a blood test before and during your treatment. Keep all appointments for blood tests. Call your health care provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
There may be other side effects of Tremfya that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
Are There Any Reasons I Should Not Use Tremfya?
Make sure your health care provider is aware of all your current or past health conditions.
You should not use Tremfya if you have an active or latent tuberculosis infection that has not been properly treated or have had a serious allergic or injection-related reaction to Tremfya.
You should not start Tremfya if you have serious liver problems.
You should not start Tremfya if you are not up-to-date with vaccines. Live vaccines should not be given during treatment. Talk to your health care provider about all of the vaccines you have received. Your health care provider can determine if you need to receive additional vaccines before starting Tremfya. Also talk to your health care provider about any upcoming vaccines you are planning on receiving. Your health care provider can determine if you may be receiving a live vaccine.
What Types of Interactions Can Happen?
Some medicines may interact with Tremfya. This interaction with Tremfya can cause a buildup of the medicine in the body. Your health care provider may need to check blood levels of some medicines that are substrates of cytochrome P450 (CYP) or adjust the dose of your medicine while you are using Tremfya. Ask your health care provider if you are taking a CYP450 substrate.
This is not a complete list of medicines that may interact with Tremfya. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions, or if you need a dosage adjustment.
Is There Any Cost Assistance Available?
There is a patient support program offered by the drugmaker that may help you afford Tremfya. Your health care provider can help you get started. For questions or more information, you can contact the drugmaker at 833-948-4631 or visit tremfya.com/ulcerative-colitis/savings-support/#prescription-support.
