Although some people with plaque psoriasis can control their symptoms by using topical treatments that are applied to the skin, some people with moderate or severe plaque psoriasis do not get enough benefit from these treatments. In these cases, medicines that are taken by mouth or injected into the body may be needed. These medicines act directly on the body’s immune system to help reduce symptoms.
One of these medicines, Tremfya, was approved for the treatment of moderate or severe plaque psoriasis in 2017. Clinical research shows that this injectable medicine may work better than some of the other injectable medicines that have been approved for this same purpose in the past.
How Does Tremfya Work for Plaque Psoriasis?
Plaque psoriasis, the most common form of psoriasis, is a type of autoimmune condition where the body’s immune cells attack its own healthy cells. In people with plaque psoriasis, the immune system attacks healthy skin cells, which causes swelling (inflammation). This can make too many skin cells form on the skin, causing discolored patches. These patches, which are known as “plaques,” are sections of thick, raised skin that may be covered with a thin silvery-white scale.
For many people, these plaques will be itchy and uncomfortable. But it is important not to scratch the itchy areas since scratching can cause the plaques to get bigger and thicker. Plaques most often appear on the scalp, elbows, knees, and lower back, although some people may get plaques on other parts of the body as well.
People with plaque psoriasis have “flare-ups,” or times when their symptoms are most noticeable. These flare-ups can last weeks or months. Many triggers can make psoriasis worse or cause a flare-up, including certain medicines. An infection, such as a cold or the flu, can also trigger a flare-up. Some other common triggers include:
- Dry and/or cold weather
- Stress
- Skin injuries, such as cuts or severe sunburns
- Smoking
- Drinking large amounts of alcohol
For most people, the key to treating plaque psoriasis is to avoid triggers, moisturize the skin, and apply topical treatments as prescribed. But this does not always work for people with very bad symptoms. People with more severe plaque psoriasis may need more treatments that target the body’s overactive immune system.
Tremfya is a medicine that blocks the effect of 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 this substance can help treat the symptoms of plaque psoriasis.
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 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 injected under the skin. Tremfya is given once every four weeks for the first two doses, and then once every eight weeks for the remaining doses.
Tremfya is injected into the thighs or stomach area by you or a caregiver. 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 or in an area that has psoriasis. Each injection should be given at a different site. Do not inject within 2 inches around your belly button.
Tremfya 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 Tremfya.
How Was Tremfya Studied?
For plaque psoriasis, three studies known as VOYAGE I, VOYAGE II, and NAVIGATE were completed to study Tremfya compared to placebo (containing no medicine) and other medicines. A fourth study known as ORION compared the Tremfya pen to a placebo. Most of the people in the studies did not know if they were getting Tremfya, a placebo, or another medicine. People were not allowed in the studies if they were taking immunosuppressives (methotrexate), had taken certain other immunosuppressives within the last three to six months, were getting light therapy for four weeks before the studies started, or had uncontrolled health conditions. They were also not allowed in the studies if they had used the study medicines previously, had active cancer or a history of cancer (except for nonmelanoma skin cancer within the last five years), or if they had a history or symptoms of TB infection. Most people in the studies were male, and some people had used other injectable biologic medicines for plaque psoriasis before.
All of the studies included people 18 and older with moderate to severe plaque psoriasis who were able to receive treatment. To be included in the studies, people had to have an Investigator’s Global Assessment (IGA) score of at least 3, a Psoriasis Area and Severity Index (PASI) score of at least 12, and a minimum body surface area (BSA) of 10% that was affected by psoriasis. The IGA score and the PASI scores are tools for measuring and monitoring psoriasis lesions. Both the IGA and PASI scores look at the thickening and hardening, redness, and scaling of lesions. The PASI score also looks at where lesions are located on the body. The higher the IGA or PASI score, the worse your plaque psoriasis is.
In the VOYAGE I and VOYAGE II studies, Tremfya was tested against a placebo and adalimumab (Humira), another medicine for plaque psoriasis, to see if it could improve psoriasis lesions after 16 weeks. In the two studies, over 1,400 people were given either 1) Tremfya at weeks 0 and 4, followed by maintenance doses every eight weeks, 2) a placebo, or 3) Humira at weeks 0 and 1, followed by maintenance doses every two weeks.
In the NAVIGATE study, over 800 people were treated with ustekinumab (Stelara), another medicine for plaque psoriasis, and if their psoriasis did not improve enough over 16 weeks, were either switched to Tremfya or continued on Stelara for another 28 weeks.
The ORION study, a small study of less than 100 people, compared the Tremfya pen to placebo in people with plaque psoriasis.
What Benefits Were Seen With Tremfya?
In the VOYAGE I and VOYAGE II studies, to assess the improvement in lesions, the amount of people who achieved an IGA score of 0 or 1 (cleared or minimal disease) and the amount of people with at least a 90% improvement in their PASI scores (PASI 90) were compared. Tremfya improved the IGA score and PASI score compared to a placebo over 16 weeks (see Table 1). Greater improvements in psoriasis symptoms (itching, pain, stinging, burning, skin tightness) were noted at 16 weeks in people treated with Tremfya compared to a placebo.
Table 1. Tremfya Compared to Placebo | ||||
VOYAGE I | VOYAGE II | |||
Week 16 | Tremfya | Placebo | Tremfya | Placebo |
IGA Response | 85% | 7% | 84% | 8% |
PASI 90 Response | 73% | 3% | 70% | 2% |
The studies also looked at whether Tremfya improved IGA scores and PASI scores compared to Humira (see Table 2 below). People treated with Tremfya were more likely to have improved IGA and PASI scores at 16 weeks compared to Humira. More people treated with Tremfya were also symptom-free at week 24 compared to Humira. Improvements in IGA and PASI scores continued with Tremfya through week 48. Of the people who did not initially respond to Humira who were switched to Tremfya, 66.1% had at least a 90% improvement in their PASI score at week 48.
Table 2. Tremfya Compared to Humira | ||||
VOYAGE I | VOYAGE II | |||
Week 16 | Tremfya | Humira | Tremfya | Humira |
IGA Response | 84% | 61% | 74% | 62% |
PASI 90 Response | 73% | 41% | 64% | 42% |
In the NAVIGATE study, of the people who did not initially respond to Stelara who were switched to Tremfya, 31.1% had their psoriasis scores improve by 2 grades at week 28.
In the ORION study, 80.6% of people who used the Tremfya pen improved their IGA score to 0 or 1 (cleared or minimal disease), compared to 0% of patients using placebo after 16 weeks. After 16 weeks, 75.8% of people using the Tremfya pen also improved their PASI score by at least 90%, compared to 0% of people using placebo.
Your results may differ from what was seen in clinical studies.
How Long Does It Take Tremfya to Work?
You may notice an improvement in your plaque psoriasis symptoms (itching, pain, stinging, burning, skin tightness) as early as two weeks after getting the first dose. In studies, plaque symptoms were decreased in most people by 16 weeks. Even more people that continued Tremfya saw decreases in plaque symptoms by 24 weeks.
You may see improvements in your plaques after the first dose, but it may take three or four doses until you see the full effects of Tremfya. Speak with your health care provider if you do not notice improvements in your plaque psoriasis symptoms within three or four doses.
What Is Its Place in Therapy?
Current psoriasis guidelines support the use of Tremfya as a treatment option in adults with moderate to severe plaque psoriasis based on good-quality evidence. Tremfya has been shown to improve psoriasis scores in people who do not respond to Humira or Stelara. Tremfya has not been studied in combination with other medicines for plaque psoriasis.
How to Prevent and Manage Side Effects
The most common side effects of Tremfya for plaque psoriasis 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 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. Hold 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 drug 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 develop 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.
Are There Any Reasons I Should Not Take Tremfya?
Make sure your health care provider is aware of all your current or past health conditions.
You should not take 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 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 Drug Interactions Can Happen with Tremfya?
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.
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 833-948-4631 at or visit tremfya.com/plaque-psoriasis/savings-and-support/.
