Tremfya Becomes First IL-23 Biologic Approved for Children with Psoriasis
The FDA approved Tremfya (guselkumab) in September 2025 for children aged 6 and older with moderate-to-severe plaque psoriasis. It’s the first IL-23 inhibitor approved for pediatric patients. In the PROTOSTAR trial, 56% of children on Tremfya achieved PASI 90 (90% or greater improvement in psoriasis) at 16 weeks, compared to 16% on placebo. Dosing follows the same every-8-week schedule used for adults.
For parents managing a child’s psoriasis, treatment choices have been few. Most newer, more targeted drugs were studied and approved only for adults. This left children’s skin doctors relying on older options with more side effects. Tremfya’s approval gives families access to one of the best drug classes for the disease.
Why Does a Pediatric Approval Matter?
Children with psoriasis face problems beyond the skin. Bullying, pulling away from friends, and low self-esteem are common. With few FDA-approved treatments, doctors have had to use adult drugs off-label or stick with less effective options. An approved biologic for children gives families a treatment tested in kids.
Psoriasis affects about 1% of children. The emotional toll on young patients is very high. Children with visible skin conditions report more teasing at school. They often avoid activities like swimming and feel different from their peers. These experiences can shape how children see themselves during key growth years.
Before this approval, the main biologic options studied in children were:
- Etanercept (Enbrel): A TNF inhibitor approved for pediatric psoriasis since 2016
- Ustekinumab (Stelara): An IL-12/23 inhibitor approved for adolescents 12 and older
Both are effective, but the IL-23 class represents a newer generation of treatment with strong efficacy data and a favorable safety profile. Tremfya’s approval extends that class to children as young as 6.
What Did the PROTOSTAR Trial Show?
The PROTOSTAR trial enrolled children ages 6-17 with moderate-to-severe psoriasis. At week 16, 56% of children receiving Tremfya achieved PASI 90 compared to 16% on placebo. Tremfya also improved quality of life scores and was well tolerated. Its safety profile matched what adult studies have shown.
The key numbers from PROTOSTAR:
- PASI 90 at week 16: 56% on Tremfya vs. 16% on placebo
- Study population: Children ages 6-17 with moderate-to-severe plaque psoriasis
- Weight requirement: 40 kg (about 88 pounds) or more
A 56% PASI 90 response rate is strong, especially in a pediatric population. For context, adult IL-23 inhibitor trials typically show PASI 90 rates of 55-75% at similar time points. Tremfya’s results in children match what’s been seen in adults.
Beyond the skin clearance numbers, the trial also measured how children felt about their condition. Quality of life gains were significant. For kids, the emotional toll of psoriasis can be worse than the physical symptoms.
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How Is Tremfya Given to Children?
Tremfya is given as a subcutaneous (under the skin) injection. Dosing starts with a 100 mg injection at the first visit. A second shot comes at week 4, then one injection every 8 weeks after that. For qualifying-weight children, the dose is the same as for adults.
The every-8-week schedule means fewer shots than most other injectable biologics require. For comparison:
- Etanercept (Enbrel): Once weekly
- Secukinumab (Cosentyx): Every 4 weeks after loading doses
- Adalimumab (Humira): Every 2 weeks
Fewer injections means fewer disruptions to a child’s routine. After the first two loading doses, families can expect about 6-7 injection visits per year. The injections can be done at a doctor’s office or, with proper training, administered at home.
For children who fear needles, fewer injections can make a big difference in how well they accept treatment. Many offices also use numbing cream and distraction tricks to make shots easier for kids.
What Are the Safety Considerations for Children?
Tremfya’s safety profile in children was consistent with what’s been seen in adults. The most common side effects were colds, injection site reactions, and headache. No new safety concerns showed up. Parents should talk with their child’s doctor about vaccines before starting treatment. Live vaccines may need to come first.
The safety profile in the PROTOSTAR trial matched Tremfya’s known adult profile. The most commonly reported side effects in children included:
- Upper respiratory infections
- Injection site reactions
- Headache
No new safety concerns appeared in children. Tremfya has been used in adults since 2017. That gives doctors nearly a decade of real-world safety data.
Parents often ask about the long-term effects of suppressing part of the immune system in a growing child. This is a valid concern, and one worth discussing with your child’s dermatologist.
IL-23 blockers target a narrow part of the immune system instead of suppressing it broadly. That’s one reason their safety profiles have been good. Long-term safety data in children will grow as more kids use the drug.
Tremfya doesn’t contain live vaccines. But talk to your child’s doctor about their vaccine schedule before starting treatment. Live vaccines may need to come before starting any biologic.
How Does This Compare to Other Pediatric Psoriasis Options?
Tremfya clears skin at higher rates than older biologics used in kids. Its PASI 90 rate of 56% at 16 weeks compares favorably to Stelara (~36% at 12 weeks, approved for ages 12+) and Enbrel (~28% at 12 weeks, approved for ages 4+). Tremfya also requires fewer injections, with dosing every 8 weeks after initial loading doses.
| Treatment | Age Approved | Type | Dosing Frequency | PASI 90 Data |
|———–|————-|——|——————|————-|
| Tremfya (guselkumab) | 6+ years | IL-23 inhibitor | Every 8 weeks | 56% at 16 weeks |
| Stelara (ustekinumab) | 12+ years | IL-12/23 inhibitor | Every 12 weeks | ~36% at 12 weeks |
| Enbrel (etanercept) | 4+ years | TNF inhibitor | Weekly | ~28% at 12 weeks |
Tremfya’s PASI 90 numbers are higher than the older options for children. But these numbers come from different trials with different designs. The best pick depends on your child’s age, weight, disease severity, and how past treatments have worked.
For children under 6 or under 40 kg, Tremfya isn’t an option yet. Etanercept is still the only biologic approved for kids as young as 4 with psoriasis.
What Questions Should Parents Ask?
Ask your child’s dermatologist whether their psoriasis is severe enough for a biologic, whether you should try older options first or go directly to an IL-23 inhibitor, how treatment fits with school and activities, what happens if your child’s weight changes, and how you’ll track whether Tremfya is working.
If your child has moderate-to-severe psoriasis and you’re considering Tremfya, here are practical questions for your next appointment:
- Is my child’s psoriasis severe enough to warrant a biologic? Not every child with psoriasis needs body-wide treatment. Many children with mild disease do well with topical treatments alone.
- Should we try older options first, or go directly to an IL-23 inhibitor? Insurers sometimes require “step therapy.” This means you must try cheaper drugs before they’ll cover a biologic. Ask what your plan requires.
- How do we handle school and activities during treatment? Tremfya’s every-8-week schedule keeps disruption low. Most children can still take part in sports, swimming, and other activities.
- What if my child gains or loses weight? Dosing is based on a minimum weight of 40 kg. Ask about dose adjustments if your child’s weight changes.
- How will we track whether it’s working? Ask your skin doctor about specific clearance goals and when to check if the drug is working.
Supporting Your Child Beyond Medication
Treatment is one piece of managing your child’s psoriasis. The emotional and social effects of visible skin problems in childhood matter too. Studies show that children with psoriasis benefit from:
- Open conversations about their condition at an age-appropriate level
- Strategies for responding to questions or comments from peers
- Connection with other children who have similar conditions (the National Psoriasis Foundation offers peer support resources)
- Screening for anxiety and depression, which affect children with psoriasis at higher rates
A drug that clears skin can boost a child’s confidence and social life. But emotional support alongside treatment produces the best results.
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Frequently Asked Questions
What age can children start Tremfya?
Tremfya is approved for children aged 6 and older who weigh at least 40 kg (about 88 pounds). It hasn’t been studied in younger children for psoriasis.
Is the dose the same as for adults?
Yes. Children who meet the weight requirement (40 kg or more) receive the same 100 mg dose on the same schedule as adults: weeks 0 and 4, then every 8 weeks.
Can my child still get vaccines while on Tremfya?
Non-live vaccines (like flu shots and COVID vaccines) can generally be given during treatment. Live vaccines should be discussed with your doctor and may need to be completed before starting Tremfya.
How long does my child need to stay on Tremfya?
Psoriasis is a chronic condition, and biologics are typically used as ongoing therapy. If your child achieves and maintains clear skin, your dermatologist may discuss whether dose adjustments or treatment pauses are appropriate.
Does Tremfya also treat psoriatic arthritis in children?
Yes. The September 2025 approval also covers active psoriatic arthritis in pediatric patients aged 6 and older (40 kg minimum weight).
Will insurance cover Tremfya for my child?
Coverage varies by plan. Johnson & Johnson offers a patient assistance program, and many specialty pharmacies have financial counselors who can help with insurance navigation. Ask your dermatologist’s office to connect you with these resources.
Sources
- Johnson & Johnson. “U.S. FDA Approves Tremfya (guselkumab) for the Treatment of Pediatric Plaque Psoriasis and Active Psoriatic Arthritis.” J&J Media Center. 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor
- AJMC. “FDA Approves Guselkumab for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis.” American Journal of Managed Care. 2025. https://www.ajmc.com/view/fda-approves-guselkumab-for-pediatric-plaque-psoriasis-active-psoriatic-arthritis
- Healio Dermatology. “FDA Approves Tremfya for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis.” Healio. 2025. https://www.healio.com/news/dermatology/20250929/fda-approves-tremfya-for-pediatric-plaque-psoriasis-active-psoriatic-arthritis
- Drugs.com. “FDA Approves Tremfya for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis.” Drugs.com. 2025. https://www.drugs.com/news/fda-approves-tremfya-pediatric-plaque-psoriasis-active-psoriatic-arthritis-126952.html
