People with psoriatic arthritis (PsA) often take medicines to help manage their condition and improve their symptoms. Some of these medicines work directly on the body's immune system and help to limit the swelling (inflammation) that causes damage to the joints over time.
Although some people will be able to manage PsA with oral medicines, others may need to use medicines that are injected into the body. One of these medicines, called Tremfya (guselkumab), may help improve symptoms in people who do not get enough benefit from oral medicines and certain types of injected medicines.
How Does Tremfya Work for Psoriatic Arthritis?
Psoriasis is a type of autoimmune condition, which means that the body's immune cells attack its own healthy cells. Although most people with psoriasis have skin symptoms (plaque psoriasis), some people with psoriasis will also have joint symptoms. This type of psoriasis is called psoriatic arthritis (PsA) and involves swelling (inflammation) in the joints. People with this condition often have warm, swollen, tender, and painful joints. Over time, swelling can cause permanent damage, which can make the joints very painful and difficult to use.
The joints most often affected by PsA are the fingers, wrists, ankles, and knees, although other joints, such as the neck and hips, can also be affected. While some people may only have these issues in one or two joints, others may have pain and swelling in multiple joints. Some people may also feel extremely tired or have a low fever.
Each person with PsA may have a different experience. Some people with this condition will have periods of "remission," when the pain or stiffness goes away for some length of time. Others will have "flare-ups," where symptoms become much worse. These flare-ups can last for days or months and may be due to stress or changes in treatment. If a person is having symptoms of PsA, their disease is considered "active."
The key to treating PsA is to reduce the swelling in the joints. This can help reduce pain and stiffness and also help prevent permanent damage to the joints. It is important to start treatment as soon as possible after you get diagnosed, so that the damage to the joints does not become severe.
There are many medicines available that help to stop the immune system from attacking its own cells and causing swelling. Since these medicines prevent damage to the joints over time, they are called disease-modifying antirheumatic drugs (DMARDs). Some of these medicines are taken by mouth and others are injected into the body. People with PsA may take more than one DMARD, as well as other medicines, to help manage the pain and swelling in their joints.
Tremfya is a DMARD that is injected into the body. 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 swelling in the joints, preventing damage and reducing pain and stiffness.
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 review your vaccination record and recommend any vaccines you may need before you start taking 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 injected under the skin. Tremfya is used once every four weeks for the first two doses, and then once every eight weeks for the remaining doses.
Tremfya is injected into the front of the thighs or stomach area by you or a caregiver. A caregiver may also inject the medicine into the back of your upper arm. Do not inject it into areas of the skin that are tender, bruised, red, or hard, or in an area that has psoriasis. Each shot should be given at a different site. Do not inject within 2 inches around your belly button.
If your health care provider decides it’s OK, they can give you instructions and teach you how to give yourself the shots at home. The medicine is stored in the refrigerator. To make the shot 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 Psoriatic Arthritis?
Two clinical studies, called DISCOVER-1 and DISCOVER-2, were done in 1,120 adults to see if Tremfya was safe and effective for the treatment of PsA. About half of the people in the studies were female and about half were male. The average age of the people in the studies was 47. Most (95%) were White, about 4% were Asian, and fewer than 1% were Native Hawaiian or Pacific Islander.
People in the studies had the following traits:
- In the DISCOVER-1 study, everyone had at least three swollen joints and three tender joints, despite past or ongoing treatment with other medicines. Everyone had tried at least one oral or injectable DMARD. About one-third of these people had tried a biologic medicine in the past, such as a TNF blocker.
- People in the DISCOVER-2 study had at least five swollen joints and five tender joints despite past or ongoing treatment with oral DMARDs.
- Everyone had active PsA for at least six months before joining the study. On average, most people were diagnosed with PsA four years before the study started.
Tremfya was compared with a placebo (containing no medicine), and no one knew if they were receiving the medicine or the placebo. If anyone was using a biologic medicine before the study started, this medicine was stopped. If anyone was using a non-biologic DMARD before the study started, they were allowed to continue taking it during the study.
These studies measured efficacy by looking at how much a person's symptoms improved. This was done by counting how many tender and swollen joints a person had before and during the study. The people in the study and their health care providers were asked to rate symptoms on a scale throughout the study. If a person's symptoms improved by at least 20%, this was considered a meaningful change.
What Benefits Were Seen With Tremfya?
Improvement in symptoms. After six months into the study, the people who used Tremfya were more likely to have their PsA symptoms improve by at least 20%. More than half (52%-64%) of people who used Tremfya had their symptoms improve by at least 20%, compared with about one-quarter to one-third (22%-33%) of people who used a placebo.
Some people in the studies had their PsA symptoms improve by a larger amount (at least 50%). About one-third (30%-32%) of people who used Tremfya had their symptoms improve by at least 50%, compared with about 9%-14% of people who used a placebo.
Your results may differ from what was seen in the clinical studies.
How Long Does It Take Tremfya to Work?
If Tremfya is working, your symptoms will start to improve over the first one to two months. Most people see the greatest improvements after six months of using the medicine.
Do not stop using this or any other medicines for PsA 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.
What Can I Do to Manage Side Effects?
The most common side effects of Tremfya for psoriatic arthritis are infection, headaches, skin reactions where the needle went in, joint pain, and diarrhea.
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 a 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 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.
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) medicine such as acetaminophen.
If you have severe diarrhea while using Tremfya, contact your health care provider. They will recommend ways to manage your diarrhea.
Tremfya can also cause allergic reactions, which can be serious. Talk to your health care about your allergies.
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 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 find out if you need to get vaccines before starting Tremfya. Also talk to your health care provider about any upcoming vaccines you are planning to get. Your health care provider can tell you 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 (CYP450) 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 know if there are any interactions, or if you need a change in dosage.
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/psoriatic-arthritis/savings-and-support/#prescription-support.
