Crohn’s disease is a type of inflammatory bowel disease that can affect any part of your intestines. It can cause parts of your intestines to get swollen, irritated, and sore. Some people may be able to control their Crohn's disease with anti-inflammatory medicines or medicines that suppress the immune system, but some people with moderately to severely active Crohn's disease need an alternative medicine. Tremfya is a biologic medicine that can help with inflammation and other symptoms caused by Crohn's disease. Below you will find common questions and answers about Tremfya.
How Does Tremfya Work for Crohn's Disease?
Tremfya is a type of medicine called a monoclonal antibody. It works by targeting a protein in your body called interleukin-23 (IL-23). IL-23 is a cytokine that causes inflammation in the body. Tremfya works in two ways: first by blocking IL-23 that has already been produced and second by binding to the CD-64 protein on cells and preventing it from producing more IL-23. This decreases inflammation that can cause symptoms of Crohn's disease.
How Will I Use Tremfya?
Tremfya is a liquid that is put either under the skin (subcutaneous injection) or into a vein (intravenous injection). Your first three doses of Tremfya will be given as subcutaneous (SC) or intravenous (IV) injections every four weeks. After that, you will get one SC injection every eight weeks starting at week 16 or every four weeks starting at week 12. A health care provider, yourself, or a caregiver may inject Tremfya SC into the front of your thigh, lower stomach, or back of the upper arm. You should not inject into areas where the skin is tender, red, bruised, hard, or affected by psoriasis. You should also not inject within 2 inches of your navel (belly button). Each injection should be put into a different site. Tremfya IV must be given by a health care provider.
Tremfya SC comes in three different dosage forms: a prefilled syringe, a one-press injector, and a prefilled pen. If your health care provider decides that you or a caregiver can inject Tremfya at home, you will get training on how to properly inject the medicine and your prescription should come with a “Instructions for Use” pamphlet. All dosage forms are stored in the refrigerator and should be left at room temperature for 30 minutes before use. You can ask your health care provider or pharmacist if you have questions on how to inject Tremfya. If you miss a dose, you should take it as soon as you remember.
Your health care provider may need to stop Tremya if you have problems with your liver or experience other severe side effects. Talk to your health care provider about all of your medical history so they can decide if Tremfya is right for you.
How Was Tremfya Studied?
Tremfya was studied in three trials in people who had moderately to severely active Crohn’s disease for at least three months and did not have a good response to other medicines used to treat Crohn’s disease.
People in Trial 1 and Trial 2 got either Tremfya IV or placebo every four weeks for three doses. There were 361 people in Trial 1; 285 received Tremfya and 76 received a placebo. The median age was 33 years old (range: 18-83) and 46% were female. Seventy-five percent of people were White, 22% were Asian, 1% were Black or African American, <1% were Native Hawaiian or Pacific Islander, and 2% did not report their racial group. In Trial 2 there were 360 people, 288 received Tremfya and 72 received placebo. The median age was 33 years (range: 18-72) and 39% were female. Seventy-three percent were White, 23% were Asian, 1% were Black or African American, <1% were Native Hawaiian or Pacific Islander, and 2% did not report their racial group.
People in Trial 3 got either Tremfya 400 milligrams every four weeks for three doses followed by 100 milligrams every eight weeks, 400 milligrams every four weeks for three doses followed by 200 milligrams every four weeks, or a placebo. There were 347 people in this trial; 230 received Tremfya and 117 received placebo. The average age was 37.5 years old, 58.5% of people were male, and the average duration of Crohn’s disease was 8 years. Sixty-six percent of people were White, 22% were Asian, 3% were Black or African American, and 9% did not report their racial group.
What Benefits Were Seen With Tremfya?
All three studies looked at clinical remission and endoscopic response. Clinical remission was defined as a Crohn’s Disease Activity Index (CDAI) score less than 150 at week 12. The CDAI score is a tool that looks at Crohn's disease symptoms to assess the severity of the disease, where lower scores indicate less severe disease. Endoscopic response was defined as at least a 50% improvement from baseline in the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score. SES-CD is a tool used to measure how severe Crohn’s disease is by looking at things like the size and number of ulcers, how much of the surface is affected, how far the disease has spread, and whether there are any narrowings (stenosis) in the gut.
In all trials, people that got Tremfya had a significantly better rate of clinical response and endoscopic response than the people in the placebo group at 12 weeks (see Table below). This means that more people in the Tremfya groups saw an improvement in their symptoms of Crohn's disease as well as an improvement in the severity of their disease.
| Trial 1 | Trial 2 | Trial 3 | ||||||
Endpoint (Week 12) | Tremfya | Placebo | Difference from Placebo | Tremfya | Placebo | Difference from Placebo | Tremfya | Placebo | Difference from Placebo |
Clinical remission | 47% | 20% | 27% | 47% | 15% | 31% | 56% | 22% | 34% |
Endoscopic response | 36% | 9% | 27% | 34% | 13% | 21%
| 34% | 15% | 19% |
In Trial 3, people who continued on Tremfya maintenance doses of either 100 milligrams every eight weeks or 200 milligrams every four weeks saw rates that were significantly higher than placebo at Week 48 for both clinical response (60% and 66.1% vs 17.1%) and endoscopic response (44.3% and 51.3% vs 6.8%).
What Should I Do Before Starting Treatment?
You should tell your health care provider if you have an infection or tuberculosis (TB). If you have a TB infection, your health care provider may have you take medicine to treat the infection before starting Tremfya. If you develop an infection or TB while taking Tremfya, your health care provider may stop your injections.
Your health care provider will review your vaccination record and recommend any vaccines you may need prior to starting Tremfya. You should not get any live vaccines while you are receiving Tremfya. Live vaccines include measles, mumps, rubella (MMR), and chickenpox.
It is unknown if Tremfya can cause harm to a fetus or will pass into your breast milk. You should tell your health care provider if you are pregnant or plan on becoming pregnant before starting Tremfya.
You should tell your health care provider if you have liver problems before starting Tremfya. You should call your health care provider if you develop any symptoms of liver problems such as dark urine (pee), nausea, vomiting, stomach pain, tiredness, rash, or yellowing of your skin or whites of your eyes.
How Long Does It Take Tremfya to Work?
You may see an improvement in some symptoms of your Crohn’s disease in four weeks, but it may take up to 12 weeks or longer to see the full effects of Tremfya.
What Are the Possible Side Effects of Tremfya, and How Can I Prevent or Manage Them?
The most common side effects of Tremfya are infections of the upper airway (respiratory infections), pain in your joints (arthralgia), feeling tired (fatigue), diarrhea, and injection site reactions.
Feeling tired is a common side effect of Tremya, but there are some things you can do to help increase your energy. Exercising each day, even if it is just for a short time, can help boost your energy. Eating a healthy diet of fruits, vegetables, lean protein, and whole grains while avoiding sugary foods may also help you fight fatigue. Your doctor may be able to give you medicines to treat other side effects such as depression, pain, or low blood counts, which may help with your fatigue.
Tremfya may cause gastrointestinal (GI) side effects such as diarrhea. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. If you experience diarrhea, your health care provider may recommend that you start diarrhea medicine and drink more fluids to avoid losing too much of your body water (dehydration).
Tremfya can cause irritation of the skin at the site where the needle is injected. You can help prevent this by making sure you inject in a different site for every injection. Also avoiding skin that is red, swollen, or sensitive may help prevent this symptom.
Infections in your airway can occur while taking Tremfya. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. Some things you can do to help with the symptoms of an infection include drinking plenty of fluids, using a saline nasal spray or humidifier, or taking over-the-counter cold or cough medicines. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough.
You may also experience muscle, bone, or joint pain while taking Tremfya. Your health care provider may recommend that you use over-the-counter pain relievers such as acetaminophen or ibuprofen, or topical (on the skin) creams or gels. You should contact your health care provider if you have pain that does not go away with over-the-counter medicines.
Is There a Cost-Savings Program for Tremfya?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Tremfya prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting www.tremfya.com/crohns-disease/savings-support/#prescription-support or by calling 833-948-4631.
