Tremfya: Uses, Dosage & Side Effects
An IL-23 inhibitor (monoclonal antibody) for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 years and older
Tremfya (guselkumab) is a prescription biologic medication used for the treatment of moderate to severe plaque psoriasis. It belongs to a class of drugs called interleukin-23 (IL-23) inhibitors and works by selectively blocking the p19 subunit of IL-23, a key cytokine involved in the inflammatory cascade that drives psoriatic skin disease. Tremfya is administered as a subcutaneous injection, with a standard adult dosing regimen of 100 mg at weeks 0 and 4, followed by 100 mg every 8 weeks. It is approved for adults and children aged 6 years and older. In pivotal clinical trials (VOYAGE 1 and VOYAGE 2), Tremfya demonstrated superior efficacy compared to placebo and the TNF inhibitor adalimumab, with approximately 73% of patients achieving a PASI 90 response at week 16. Tremfya has a favorable safety profile, with upper respiratory infections being the most commonly reported side effect.
Quick Facts: Tremfya
Key Takeaways
- Tremfya (guselkumab) is a fully human monoclonal antibody that selectively blocks IL-23, a key cytokine driving the inflammatory process in plaque psoriasis, offering targeted treatment with a favorable safety profile.
- After initial loading doses at weeks 0 and 4, Tremfya is administered every 8 weeks, providing a convenient dosing schedule that supports long-term treatment adherence.
- In head-to-head clinical trials (VOYAGE 1 and VOYAGE 2), Tremfya demonstrated superior efficacy compared to adalimumab (Humira), with approximately 73% of patients achieving PASI 90 (90% skin clearance) at week 16.
- Tremfya is now approved for children aged 6 years and older with moderate to severe plaque psoriasis, with weight-based dosing for children under 40 kg using a specially designed adjustable pre-filled pen.
- Upper respiratory tract infections are the most common side effect; serious infections and severe allergic reactions are rare. Patients should be evaluated for tuberculosis before starting treatment and should not receive live vaccines during therapy.
What Is Tremfya and What Is It Used For?
Tremfya contains the active substance guselkumab, a fully human monoclonal antibody of the immunoglobulin G1 lambda (IgG1λ) subclass. It is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. As a monoclonal antibody, Tremfya is a highly specialized protein designed to recognize and bind with exceptional precision to one specific molecular target in the body. In the case of guselkumab, that target is the p19 subunit of interleukin-23 (IL-23), a pro-inflammatory cytokine that plays a pivotal role in the pathogenesis of psoriasis and several other immune-mediated inflammatory diseases.
IL-23 is a heterodimeric cytokine composed of two subunits: p19 (unique to IL-23) and p40 (shared with IL-12). It is produced predominantly by activated dendritic cells and macrophages in the skin and other tissues. IL-23 is considered a master regulatory cytokine in the Type 17 immune pathway because it is essential for the differentiation, expansion, survival, and effector functions of T helper 17 (Th17) cells and other IL-17-producing cell subsets, including gamma-delta T cells, innate lymphoid cells (ILC3), and mucosal-associated invariant T (MAIT) cells. These cells produce downstream pro-inflammatory cytokines—including IL-17A, IL-17F, and IL-22—that are directly responsible for the keratinocyte hyperproliferation, abnormal differentiation, and neutrophil recruitment that characterize psoriatic plaques.
By selectively binding to the p19 subunit, guselkumab blocks IL-23 from interacting with its receptor (IL-23R) on the surface of target immune cells. This upstream blockade effectively shuts down the entire IL-23/Th17 inflammatory axis without directly interfering with IL-12 signaling (which shares the p40 subunit with IL-23 but signals through a distinct pathway important for Th1 cell responses and host defense against intracellular pathogens). This selectivity is considered a clinical advantage over older biologics such as ustekinumab, which blocks both IL-12 and IL-23 by targeting the shared p40 subunit.
Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is also approved for the treatment of moderate to severe plaque psoriasis in children aged 6 years and older. Plaque psoriasis is the most common form of psoriasis, affecting approximately 2–3% of the global population. It is characterized by well-demarcated, raised, erythematous plaques covered with silvery-white scales, most commonly found on the scalp, elbows, knees, and lower back. Beyond the visible skin lesions, psoriasis is associated with significant physical discomfort (itching, pain, skin cracking and bleeding), psychological burden (anxiety, depression, social isolation), and systemic comorbidities including psoriatic arthritis, cardiovascular disease, metabolic syndrome, and inflammatory bowel disease.
The efficacy of Tremfya has been established in several large, randomized, double-blind, placebo-controlled and active-comparator clinical trials. The two pivotal phase III studies are:
- VOYAGE 1: This trial enrolled 837 adults with moderate to severe plaque psoriasis. At week 16, 73.3% of patients treated with guselkumab achieved a PASI 90 response (90% or greater improvement from baseline Psoriasis Area and Severity Index score) compared with 2.9% for placebo and 49.7% for adalimumab. At week 24, the PASI 90 response rate for guselkumab increased to 80.2%. Complete skin clearance (PASI 100) was achieved by 37.4% of guselkumab-treated patients at week 16, compared with 12.4% for adalimumab.
- VOYAGE 2: This trial enrolled 992 adults and included a randomized withdrawal and retreatment design. At week 16, 70.0% of guselkumab patients achieved PASI 90 compared with 2.4% for placebo and 46.8% for adalimumab. Long-term data through 5 years demonstrated sustained efficacy with continued guselkumab treatment, with approximately 82% of patients maintaining PASI 90 at week 252.
In the head-to-head comparisons with adalimumab (one of the most widely prescribed biologics for psoriasis at the time of the trials), guselkumab demonstrated statistically superior efficacy across all primary and key secondary endpoints. These results established Tremfya as one of the most effective biologic therapies available for plaque psoriasis. Subsequent real-world evidence and network meta-analyses have confirmed these findings, consistently ranking guselkumab among the top-performing biologics for psoriasis alongside other IL-23 inhibitors (risankizumab) and IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab).
Tremfya was first approved by the U.S. Food and Drug Administration (FDA) in July 2017 and by the European Medicines Agency (EMA) in November 2017. It is now approved in more than 70 countries worldwide. The more recent pediatric approval (for children aged 6 years and older) represents an important expansion of treatment options for younger patients with moderate to severe plaque psoriasis, a population with limited approved biologic therapies.
By targeting IL-23 at the top of the inflammatory cascade rather than downstream effector cytokines, guselkumab offers the potential for deep and sustained disease remission. Many patients treated with IL-23 inhibitors maintain excellent skin clearance even after treatment withdrawal, suggesting that blocking this upstream cytokine may help “reset” the aberrant immune response in psoriasis. This has led to growing interest in the concept of treatment-free remission in psoriasis.
What Should You Know Before Taking Tremfya?
Contraindications
Tremfya must not be used in the following circumstances:
- Hypersensitivity: Do not use Tremfya if you are allergic to guselkumab or to any of the other ingredients in the formulation (histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injections). If you suspect you may be allergic, consult your doctor before using Tremfya.
- Active infections: Do not use Tremfya if you have an active infection, including active tuberculosis (TB). Guselkumab modulates immune function by blocking IL-23, which plays a role in host defense against certain infections. Starting treatment during an active infection could worsen the infection or impair your body’s ability to fight it.
Warnings and Precautions
Tremfya may cause serious side effects, including infections and allergic reactions. Stop using Tremfya and seek immediate medical attention if you develop signs of a serious allergic reaction (swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing or breathing; dizziness; or hives) or symptoms of a serious infection (fever, muscle pain, cough, shortness of breath, burning on urination, bloody sputum, weight loss, diarrhea, abdominal pain, or warm, red, or painful skin).
Talk to your doctor, pharmacist, or nurse before using Tremfya if any of the following apply to you:
- Current or recurrent infections: If you are being treated for an infection, have an infection that keeps coming back, or are prone to infections, tell your doctor. Guselkumab may lower your body’s ability to fight infections. Your doctor may decide to delay treatment until the infection has resolved.
- Tuberculosis (TB): Your doctor will evaluate you for TB before starting Tremfya. If you have latent TB, you may need to receive TB treatment before starting guselkumab. If you have been in close contact with someone who has active TB, inform your doctor. During treatment, continue to be monitored for signs and symptoms of TB.
- Vaccinations: You should not receive live vaccines while using Tremfya. Inactivated (killed) vaccines can generally be given during treatment. For children, ensure that all age-appropriate vaccinations are up to date before starting Tremfya therapy. If you have a planned vaccination, discuss the timing with your doctor.
Children and Adolescents
Tremfya is approved for the treatment of moderate to severe plaque psoriasis in children aged 6 years and older. It should not be given to children younger than 6 years as it has not been studied in this age group. For children aged 6 and older who weigh less than 40 kg, a weight-based dose is administered using a specially designed pre-filled pen containing 45 mg/0.45 mL, which allows the healthcare provider or trained caregiver to dial the appropriate dose. Children weighing 40 kg or more receive the standard adult 100 mg dose. Before starting treatment, children should have received all age-appropriate vaccinations.
Pregnancy and Breastfeeding
Tremfya should not be used during pregnancy as the effects of guselkumab on the developing fetus have not been adequately studied. As an IgG1 monoclonal antibody, guselkumab is expected to cross the placenta, particularly during the second and third trimesters. Women of childbearing potential are advised to use effective contraception during treatment and for at least 12 weeks after the last dose of Tremfya. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
It is not known whether guselkumab passes into human breast milk. Human IgG antibodies are known to be present in breast milk, particularly during the first days after birth. The decision to breastfeed during Tremfya treatment should be made together with your doctor, balancing the benefits of breastfeeding for the infant against the benefits of treatment for the mother.
Driving and Operating Machinery
Tremfya is unlikely to affect your ability to drive or operate machinery. Based on its pharmacological properties and known side effect profile, no significant impairment of these abilities is expected. However, if you experience any adverse effects that could affect your alertness or coordination, refrain from driving or operating machinery until you feel well again.
Important Information About Ingredients
Tremfya contains polysorbate 80 (0.3 mg per pre-filled pen, equivalent to 0.5 mg/mL). Polysorbates may cause allergic reactions in susceptible individuals. Inform your doctor if you have any known allergies to polysorbates or other excipients. The other inactive ingredients include histidine, histidine hydrochloride monohydrate, sucrose, and water for injections.
How Does Tremfya Interact with Other Drugs?
One of the notable practical advantages of Tremfya as a biologic therapy for psoriasis is its favorable drug interaction profile. Unlike many conventional systemic treatments for psoriasis (such as methotrexate, cyclosporine, or acitretin), which are metabolized by hepatic enzymes and can interact with numerous other medications, guselkumab is a monoclonal antibody that is degraded through general protein catabolic pathways. It is not metabolized by cytochrome P450 (CYP) enzymes, and therefore is not expected to participate in CYP-mediated drug-drug interactions.
No formal drug interaction studies have been conducted with guselkumab. Population pharmacokinetic analyses from the clinical trial program did not identify any clinically meaningful effects of concomitant medications on guselkumab pharmacokinetics. Similarly, guselkumab is not expected to affect the metabolism, absorption, or elimination of other drugs.
In clinical trials, Tremfya was used alongside a variety of medications commonly prescribed to psoriasis patients, with no evidence of adverse interactions:
| Drug Category | Examples | Interaction Status |
|---|---|---|
| Topical corticosteroids | Betamethasone, clobetasol, mometasone | No interaction identified |
| Topical vitamin D analogues | Calcipotriol, calcitriol | No interaction identified |
| NSAIDs | Ibuprofen, naproxen, diclofenac | No interaction identified |
| Methotrexate | Oral or subcutaneous methotrexate | No interaction identified |
| Antihypertensives | ACE inhibitors, ARBs, beta-blockers | No interaction identified |
| Statins | Atorvastatin, rosuvastatin, simvastatin | No interaction identified |
| Antidiabetics | Metformin, insulin, sulfonylureas | No interaction identified |
| Antidepressants | SSRIs, SNRIs, tricyclics | No interaction identified |
Vaccines
While Tremfya does not interact with conventional drugs, there is an important restriction regarding live vaccines. Patients receiving Tremfya should not receive live vaccines (such as live attenuated influenza vaccine, MMR, varicella, BCG, or live typhoid vaccine) because guselkumab modulates the immune system and could theoretically reduce the immune response to live vaccines or increase the risk of infection from the live vaccine strain. Inactivated vaccines (such as inactivated influenza vaccine, pneumococcal vaccine, hepatitis B vaccine, and COVID-19 mRNA vaccines) can generally be administered during Tremfya treatment, although the immune response may be somewhat reduced. Ideally, all recommended vaccinations should be completed before starting Tremfya therapy.
Because guselkumab is a monoclonal antibody cleared by protein catabolism rather than hepatic metabolism, it does not affect or is not affected by drugs metabolized through the cytochrome P450 system. This makes Tremfya particularly suitable for psoriasis patients who take multiple medications for comorbid conditions such as cardiovascular disease, diabetes, or depression—conditions that are more prevalent in the psoriasis population.
What Is the Correct Dosage of Tremfya?
Adults
The recommended dosing regimen of Tremfya for adults with moderate to severe plaque psoriasis is as follows:
Standard Adult Dosing Regimen
- Initial dose: 100 mg by subcutaneous injection at week 0
- Second dose: 100 mg at week 4
- Maintenance dose: 100 mg every 8 weeks thereafter
The 100 mg dose is administered using a pre-filled pen (Tremfya OnePress or Tremfya PushPen) or pre-filled syringe. The injection should be given subcutaneously (under the skin) into the front of the thigh, the lower abdomen (avoiding the 5 cm area around the navel), or the back of the upper arm. Injection sites should be rotated with each injection, and injections should not be given into skin that is tender, bruised, red, scaly, hard, thick, scarred, or affected by psoriasis.
After initial training from a healthcare professional, patients or their caregivers may self-administer Tremfya at home. Your doctor will determine the duration of treatment based on your response and the clinical course of your psoriasis. In clinical trials, sustained efficacy has been demonstrated for up to 5 years of continuous treatment. Discontinuation of treatment should be discussed with your doctor, as psoriasis symptoms may return after stopping Tremfya.
Children (6 Years and Older)
Tremfya is approved for children aged 6 years and older with moderate to severe plaque psoriasis. The dosing depends on the child’s body weight:
| Body Weight | Dose | Formulation | Schedule |
|---|---|---|---|
| Less than 40 kg | Weight-based (set by dial on pen) | 45 mg/0.45 mL adjustable pre-filled pen | Week 0, week 4, then every 8 weeks |
| 40 kg or more | 100 mg | 100 mg pre-filled syringe | Week 0, week 4, then every 8 weeks |
For children weighing less than 40 kg, the dose is determined by body weight and is set using the adjustable dial on the specially designed 45 mg/0.45 mL pre-filled pen. The available dose settings are 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, and 45 mg. Your doctor will determine the correct dose for your child. The initial injection should be given by a healthcare professional. Subsequent injections may be administered by a trained caregiver at home.
Elderly Patients
No dose adjustment is required for elderly patients. The safety and efficacy of Tremfya in patients aged 65 years and older were consistent with those observed in younger adults in clinical trials. However, the overall number of elderly patients in the clinical development program was limited, and a higher susceptibility to infections in older patients cannot be excluded. Healthcare providers should exercise appropriate clinical judgment when treating elderly patients with Tremfya.
Missed Dose
If you forget to inject a dose of Tremfya, administer it as soon as possible. Then continue your regular dosing schedule from the date of the missed injection. Do not inject a double dose to make up for a missed one. If you are unsure when to give your next dose, contact your doctor or pharmacist for guidance.
Overdose
If you have received more Tremfya than prescribed, or if the dose was given earlier than scheduled, inform your doctor. In clinical trials, single doses up to 300 mg were administered subcutaneously without dose-limiting toxicity. In the event of an overdose, monitor the patient for signs and symptoms of adverse reactions and provide appropriate symptomatic treatment as necessary.
Stopping Treatment
You should not stop using Tremfya without first discussing it with your doctor. If you stop treatment, your psoriasis symptoms may return. In the VOYAGE 2 trial, patients who were withdrawn from guselkumab after achieving skin clearance experienced gradual disease recurrence, although the time to relapse was generally longer than with conventional therapies. If relapse occurs, retreatment with the same dosing regimen can restore disease control in most patients.
What Are the Side Effects of Tremfya?
Like all medicines, Tremfya can cause side effects, although not everybody gets them. The side effects of guselkumab are generally mild to moderate in severity and rarely lead to treatment discontinuation. The following side effects have been reported in clinical trials and post-marketing surveillance:
Stop using Tremfya and seek emergency medical care immediately if you experience signs of a potentially serious allergic reaction (anaphylaxis): difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, severe skin itching with red rash or raised bumps, dizziness, low blood pressure, or lightheadedness. These reactions are rare (may affect up to 1 in 1,000 patients) but can be life-threatening.
Very Common
May affect more than 1 in 10 patients
- Upper respiratory tract infections (common cold, pharyngitis, nasopharyngitis, sinusitis)
Common
May affect up to 1 in 10 patients
- Headache
- Joint pain (arthralgia)
- Diarrhea
- Elevated liver enzymes in blood tests
- Skin rash
- Injection site reactions (redness, irritation, or pain at the injection site)
Uncommon
May affect up to 1 in 100 patients
- Decreased neutrophil count (a type of white blood cell)
- Herpes simplex infections (cold sores)
- Skin fungal infections (e.g., athlete’s foot, tinea)
- Gastroenteritis (stomach flu)
- Urticaria (hives)
Rare
May affect up to 1 in 1,000 patients
- Serious allergic reactions (anaphylaxis)
Injection Site Reactions
Injection site reactions are among the most commonly reported side effects with Tremfya and typically include redness, pain, swelling, itching, or bruising at the injection site. These reactions are generally mild to moderate, transient, and do not require treatment discontinuation. They usually resolve within a few days. Rotating injection sites with each dose can help minimize injection site reactions. If an injection site reaction is severe or does not resolve, contact your healthcare provider.
Infections
Because Tremfya modulates the immune system by blocking IL-23, it may increase the susceptibility to certain infections. Upper respiratory tract infections (including the common cold, sinusitis, pharyngitis, and nasopharyngitis) are the most commonly reported infectious adverse events. More serious infections, including lower respiratory tract infections, cellulitis, and herpes zoster, have been reported uncommonly. Before starting Tremfya, your doctor should screen you for tuberculosis and evaluate any active or latent infections. During treatment, be vigilant for signs and symptoms of infection and report any concerns to your healthcare provider promptly.
Long-Term Safety
Long-term safety data from clinical trials extending up to 5 years have shown a consistent and favorable safety profile for Tremfya, with no new safety signals emerging over time. The rates of serious infections, malignancies, and major adverse cardiovascular events (MACE) remained low and comparable to background rates in the psoriasis population. No significant laboratory abnormalities, including liver or kidney function tests, were attributable to guselkumab treatment. These data support the long-term use of Tremfya for the chronic management of plaque psoriasis.
Seek medical advice promptly if you develop signs of infection (fever, flu-like symptoms, muscle pain, cough, shortness of breath, burning on urination, bloody sputum, weight loss, warm or painful skin), or if you notice any side effects that become severe or persistent. Your doctor may need to adjust your treatment or provide additional care.
How Should You Store Tremfya?
Proper storage of Tremfya is essential to maintain the medication’s effectiveness and safety. Follow these storage guidelines carefully:
- Refrigeration: Store the pre-filled pen in the refrigerator at 2°C to 8°C (36°F to 46°F). Keep it in the original carton to protect the solution from light and physical damage.
- Do not freeze: Never freeze Tremfya. If the medication has been accidentally frozen, do not use it—contact your pharmacist for a replacement.
- Do not shake: Shaking may damage the protein structure of the monoclonal antibody and reduce its effectiveness.
- Before use: Remove the carton from the refrigerator and allow the pre-filled pen to reach room temperature for approximately 30 minutes before injection. Do not warm it by any other means (e.g., microwave or hot water).
- Visual inspection: Before use, check the solution through the viewing window. It should be clear, colorless to light yellow, and may contain small white or translucent particles. Small air bubbles are normal. Do not use the solution if it is cloudy, discolored, or contains large particles.
- Expiry date: Check the expiry date (“EXP”) on the pen label and carton. Do not use after the expiry date, which refers to the last day of the stated month.
- Single use only: Each pre-filled pen is intended for a single injection. Discard the used pen in a sharps disposal container immediately after use, even if there is residual medication remaining.
Keep Tremfya out of the sight and reach of children. Do not dispose of the pen in household waste or recycling. Ask your pharmacist how to properly dispose of medicines and sharps containers that are no longer needed. These measures help protect the environment.
If you need to travel with Tremfya, use an insulated cooler bag with ice packs to maintain the recommended temperature range. Avoid exposing the medication to direct sunlight or extreme temperatures. When flying, keep Tremfya in your carry-on luggage (not checked baggage) to avoid exposure to freezing temperatures in the cargo hold. Carry a letter from your doctor explaining the medical necessity of the medication and the injection device.
What Does Tremfya Contain?
Active Ingredient
The active substance in Tremfya is guselkumab, a fully human IgG1 lambda monoclonal antibody directed against the p19 subunit of interleukin-23. Two formulations are available:
- Tremfya 100 mg: Each pre-filled pen or syringe contains 100 mg of guselkumab in 1 mL of solution. This formulation is used for adult dosing and for children weighing 40 kg or more.
- Tremfya 45 mg/0.45 mL: Each adjustable pre-filled pen contains 45 mg of guselkumab in 0.45 mL of solution. This formulation is specifically designed for weight-based dosing in children weighing less than 40 kg, with adjustable dose settings from 20 mg to 45 mg.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Histidine | Buffer (pH stabilizer) | Maintains optimal pH for protein stability |
| Histidine hydrochloride monohydrate | Buffer (pH stabilizer) | Works with histidine to maintain pH |
| Polysorbate 80 (E433) | Surfactant (stabilizer) | Prevents protein aggregation; may cause allergic reactions in rare cases |
| Sucrose | Tonicity modifier / stabilizer | Protects the antibody during storage |
| Water for injections | Solvent | Pharmaceutical-grade water |
Appearance and Packaging
Tremfya solution for injection is a clear, colorless to light yellow liquid. It is available as:
- Tremfya 100 mg: Supplied in a pre-filled pen (OnePress or PushPen) or pre-filled syringe. Available in packs of 1 or 2 pre-filled pens/syringes.
- Tremfya 45 mg/0.45 mL: Supplied in an adjustable-dose pre-filled pen for pediatric use. Available in packs of 1.
Marketing Authorization
Tremfya is manufactured by Janssen Biologics B.V. (Leiden, Netherlands) and marketed by Janssen-Cilag International NV (Beerse, Belgium). The marketing authorization holder for the European Union is Janssen-Cilag International NV. In the United States, Tremfya is marketed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson.
Frequently Asked Questions About Tremfya
Tremfya (guselkumab) is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and in children aged 6 years and older. It is also approved for the treatment of active psoriatic arthritis in adults in some countries. Tremfya works by blocking interleukin-23 (IL-23), a key cytokine that drives the inflammation underlying these conditions. It is not used for mild psoriasis or as a first-line treatment.
Tremfya belongs to the IL-23 inhibitor class, which targets a specific upstream cytokine in the psoriasis inflammatory cascade. Unlike TNF inhibitors (adalimumab, etanercept) that broadly suppress inflammation, or IL-12/23 inhibitors (ustekinumab) that block both IL-12 and IL-23, Tremfya selectively blocks only IL-23 by binding its p19 subunit. This targeted approach results in high efficacy rates (approximately 73% PASI 90 at week 16) with a favorable safety profile. Compared to IL-17 inhibitors (secukinumab, ixekizumab), IL-23 inhibitors like Tremfya generally have a lower incidence of candidiasis and may offer more durable responses.
Yes, after receiving proper training from a healthcare professional, you can self-inject Tremfya at home using the pre-filled pen. The pen is designed for ease of use with a single-button injection mechanism. Before self-injecting for the first time, your doctor or nurse will demonstrate the proper technique. Follow the instructions for use provided in the medication packaging carefully. Inject into the front of the thigh, the lower abdomen (avoiding the area around the navel), or the back of the upper arm. Rotate injection sites with each dose.
If you stop taking Tremfya, your psoriasis symptoms may gradually return over time. In the VOYAGE 2 clinical trial, patients who discontinued guselkumab after achieving skin clearance experienced relapse at a median of approximately 15 weeks, although some maintained response for considerably longer. Notably, when patients were retreated with Tremfya after relapse, they generally regained their previous level of skin clearance. You should always discuss any planned treatment changes with your dermatologist rather than stopping treatment on your own.
Clinical trial data extending up to 5 years support the long-term safety of Tremfya. The rates of serious adverse events, serious infections, malignancies, and major adverse cardiovascular events remained low and stable throughout the extended treatment period. No new safety concerns emerged with prolonged use. Anti-drug antibody development was uncommon (approximately 5–7% of patients) and generally did not affect the efficacy or safety of the medication. These data support Tremfya as a suitable option for the long-term management of chronic plaque psoriasis.
Yes, Tremfya is approved for children aged 6 years and older with moderate to severe plaque psoriasis. Children weighing less than 40 kg receive a weight-based dose using a specially designed adjustable pre-filled pen (45 mg/0.45 mL), while children weighing 40 kg or more receive the standard adult dose of 100 mg. The initial injection should be given by a healthcare professional, and subsequent injections may be given by a trained caregiver at home. Children should have received all age-appropriate vaccinations before starting Tremfya. The medication has not been studied in children under 6 years of age.
References
- European Medicines Agency (EMA). Tremfya (guselkumab) – Summary of Product Characteristics. Last updated 2025.
- U.S. Food and Drug Administration (FDA). Tremfya (guselkumab) – Prescribing Information. Janssen Biotech, Inc. Revised 2024.
- Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405–417.
- Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831–839.
- Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178(1):114–123.
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–1072.
- Smith CH, Yiu ZZN, Bale T, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020;183(4):628–637.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd List. Geneva: WHO; 2023.
- Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301–1315.
- Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1 and DISCOVER-2): results from two randomised, double-blind, placebo-controlled, phase 3 trials. Lancet. 2020;395(10230):1115–1125.
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