Tremfya

Tremfya (guselkumab) is a prescription biologic medicine used to treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease in certain patients. It works by blocking interleukin-23 (IL-23), a protein that drives inflammation; this helps reduce inflammation and improve symptoms affecting the skin, joints, and gastrointestinal tract.

Tremfya is given as an injection under the skin (subcutaneous injection) every 4 to 8 weeks as a maintenance dose. For ulcerative colitis or Crohn's disease, the induction doses may be administered as an infusion into a vein (intravenous infusion).

Tremfya is FDA-approved to treat four inflammatory conditions. Its approved uses are:

• Moderate-to-severe plaque psoriasis in adults and children 6 years and older who weigh at least 40 kg (about 88 lb) and who are candidates for injections or pills (systemic therapy) or light treatment (phototherapy)
• Active psoriatic arthritis in adults and children 6 years and older who weigh at least 40 kg (about 88 lb)
• Moderately to severely active ulcerative colitis in adults
• Moderately to severely active Crohn's disease in adults

Tremfya works by selectively blocking interleukin-23 (IL-23), a naturally occurring protein (cytokine) that helps drive inflammation in autoimmune disease. Guselkumab is a human monoclonal antibody whose mechanism of action is to bind to the p19 subunit of IL-23 and stop it from attaching to its receptor. By blocking IL-23, Tremfya lowers the release of the inflammatory signals that affect the skin, joints, and gut.

Tremfya is a biologic medicine, not a steroid, and it is not a TNF inhibitor. Tremfya belongs to a class of medicines called interleukin-23 (IL-23) inhibitors, also known as IL-23 antagonists, so it targets one specific part of the inflammatory pathway rather than broadly suppressing the immune system.

This medicine may cause serious side effects.The most important safety information to know is:

• Serious allergic reactions. Serious reactions, including anaphylaxis, can occur. Stop using Tremfya and get emergency medical help if you have symptoms such as trouble breathing, chest tightness, swelling of your face, lips, tongue, or throat, dizziness, or hives.
• Infections. Tremfya can lower your immune system's ability to fight infection and may raise your risk of infection. Your provider will check you for infection before treatment, and treatment should not be started during a clinically important active infection.
• Tuberculosis (TB). Your provider will test you for TB before you start Tremfya and may treat latent TB first.
• Liver problems. Drug-induced liver injury has been reported. Your provider may check your liver enzymes and bilirubin before and during treatment, especially for ulcerative colitis or Crohn's disease.
• Live vaccines. Avoid live vaccines during treatment, and complete age-appropriate vaccinations before you start.

Tremfya does not have a boxed warning.

Do not use Tremfya if you have had a serious allergic reaction to guselkumab or any of its ingredients. Before starting treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that will not go away or that keeps coming back
• have tuberculosis (TB), or have been in close contact with someone who has TB (your provider will check you for TB before you start Tremfya and may treat latent TB first)
• have or have had liver problems
• have recently received or are scheduled to receive a vaccine (avoid live vaccines during treatment, and complete age-appropriate vaccinations before starting)
• are pregnant, plan to become pregnant, or are breastfeeding

For ulcerative colitis or Crohn's disease, your provider will check your liver enzymes and bilirubin before treatment, for at least the first 16 weeks, and periodically after that.

Pregnancy

It is not known whether Tremfya can harm an unborn baby, and there is not enough data to say for certain. Tremfya is a monoclonal antibody, and antibodies like it can cross the placenta, especially during the third trimester, so it may reach the baby. If you become pregnant during treatment, you can join the MotherToBaby pregnancy registry, which monitors outcomes in people who use Tremfya during pregnancy, at mothertobaby.org or by calling 1-877-311-8972.

Breastfeeding

It is not known whether guselkumab passes into breast milk or how it might affect a breastfed baby. Talk with your healthcare provider about the benefits of breastfeeding alongside your need for Tremfya.

Common Tremfya side effects

The most common side effects of Tremfya include respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), bronchitis, and fungal skin infections (tinea) or herpes simplex infections. In people treated for ulcerative colitis or Crohn's disease, fatigue, fever (pyrexia), abdominal pain, and rash were also reported.

Serious Tremfya side effects

Serious side effects can occur. Get emergency medical help if you have signs of a serious allergic reaction, such as hives, rash, itching, chest tightness, trouble breathing, dizziness or fainting, or swelling of your face, lips, tongue, or throat.

Tremfya can lower your immune system's ability to fight infection. Call your healthcare provider right away if you have signs of infection, such as fever, sweats, chills, muscle aches, weight loss, cough, shortness of breath, burning when you urinate, or skin sores that look different from your psoriasis. Liver problems (drug-induced liver injury) have also been reported. Tell your healthcare provider right away if you notice an unexplained rash, nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of the skin or eyes, or dark urine.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Does Tremfya cause weight gain or weight loss?

Weight gain and weight loss are not known side effects of Tremfya. They were not reported in the clinical trials or listed in the prescribing information. If your weight changes during treatment, it is more likely related to your underlying condition or other factors, so tell your healthcare provider so they can help find the cause.

Tremfya is usually given as an injection under the skin (subcutaneous injection) every 4 to 8 weeks as a maintenance dose. For ulcerative colitis and Crohn's disease, the induction doses may instead be given as an intravenous infusion by a healthcare provider.

After proper training, adults may self-inject at home using the prefilled pen, prefilled syringe, or One-Press injector. Children should be given their injections by a healthcare provider or a trained caregiver, not by self-injection.

The recommended dosage depends on the condition being treated.

Before injecting, take Tremfya out of the refrigerator and let it reach room temperature for about 30 minutes with the needle cap on. Do not shake it. Tremfya should look clear and colorless to light yellow and may contain small translucent particles. Do not use it if the liquid contains large particles or looks discolored or cloudy. Do not inject into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Each pen, syringe, or injector is for one use only.

For the full dosing schedule, missed-dose guidance, and preparation steps, see the Tremfya dosage information page.

Tremfya for plaque psoriasis

After 16 weeks of Tremfya, 84% to 85% of adults with moderate-to-severe plaque psoriasis had clear or almost clear skin (an IGA score of 0 or 1), and 70% to 73% had at least a 90% improvement in their psoriasis (a PASI 90 response). These results are from the clinical trials, PsO1 and PsO2, that supported FDA approval. Tremfya is approved for adults and for children 6 years and older who weigh at least 40 kg, and it also improved scalp psoriasis and symptoms such as itch, pain, and burning.

Tremfya for psoriatic arthritis

In the PsA2 trial, after 24 weeks of Tremfya, 64% of adults had at least a 20% improvement in joint symptoms (an ACR20 response), compared with 33% of those on placebo, and a second trial (PsA3) showed a similar benefit (68% versus 47%). These results are from the clinical trials that supported FDA approval. Tremfya also significantly slowed the progression of joint damage seen on X-ray compared with placebo. It is approved for adults and for children 6 years and older who weigh at least 40 kg, and it can be used alone or together with a conventional DMARD such as methotrexate.

Tremfya for ulcerative colitis

After 12 weeks of Tremfya, 23% of adults with moderately to severely active ulcerative colitis reached clinical remission, compared with 8% on placebo, in clinical trial UC1. Among those who continued treatment, up to about 50 percent were in remission at one year (Week 44) compared to 19% for placebo, in Trial UC2. Improvements in symptoms such as rectal bleeding and stool frequency were seen as early as Week 3 to Week 4.

Tremfya for Crohn's disease

After 12 weeks of Tremfya, about 47% of adults with moderately to severely active Crohn's disease reached clinical remission, compared with 15% to 20% on placebo, in Trials CD1 and CD2. More than half of those who continued treatment were in remission at about one year (Week 48), in Trial CD3. Reductions in stool frequency and abdominal pain were seen as early as Week 4.

For the full study details, see the Tremfya prescribing information.

How long does Tremfya take to work?

Tremfya can begin to ease symptoms within a few weeks, though how soon you notice a difference and how long the full benefit takes depends on the condition. In ulcerative colitis and Crohn's disease, reductions in symptoms such as stool frequency, rectal bleeding, and abdominal pain were seen as early as Week 3 to Week 4. In plaque psoriasis, many people saw meaningful skin improvement by about Week 16. In psoriatic arthritis, joint symptom response (ACR20) was measured through Week 24. Individual results vary, and your healthcare provider will decide how long to continue treatment.

How long does Tremfya stay in your system?

Tremfya can stay in your system for roughly 3 months (about 10 to 13 weeks) after your last dose. This is because Tremfya has a half-life of about 15 to 18 days, which is the time it takes for the amount of medicine in your body to fall by half, and a medicine is generally considered cleared after about five half-lives. This long-lasting effect is part of why maintenance doses are usually given only every 8 weeks for most conditions.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products.

Live vaccines. Avoid live vaccines while taking Tremfya, because the vaccine may not work as well and the combination may increase infection risk.

CYP450 substrates. When Tremfya is started in someone taking a medicine processed by certain liver enzymes (a CYP450 substrate), especially one with a narrow therapeutic index, the provider may monitor the medicine's effect or blood levels and adjust the dose if needed.

Not all possible interactions are listed here.

• Store Tremfya in the refrigerator between 36 F and 46 F (2 C and 8 C)
• Keep it in the original carton to protect it from light until you are ready to use it
• Do not freeze and do not shake
• Before injecting, let it reach room temperature (up to 77 F or 25 C) for about 30 minutes with the needle cap on
• Keep Tremfya and all medicines out of the reach of children

Tremfya is preservative-free, so throw away any unused medicine left in a pen, syringe, injector, or vial.

Tremfya received its initial U.S. FDA approval in 2017 for plaque psoriasis. Its approved uses have since expanded to include psoriatic arthritis, ulcerative colitis, Crohn's disease, and use in eligible children 6 years and older. For the full approval timeline and label changes, see the Tremfya FDA approval history.

Active ingredient: guselkumab.

Inactive ingredients in the prefilled syringe, One-Press injector, and prefilled pen are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection. The single-dose vial for intravenous infusion also contains EDTA disodium dihydrate and L-methionine. Tremfya is not made with natural rubber latex.

Tremfya is manufactured by Janssen Biotech, Inc., Horsham, PA, a Johnson & Johnson company.