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What is the age limit for STELARA? Understanding Eligibility by Condition

According to the U.S. Food and Drug Administration (FDA), the age limit for STELARA (ustekinumab) varies depending on the medical condition it is being used to treat. While it is approved for some pediatric patients, other indications are limited to adults, making it crucial to understand the specific guidelines for each use. This guide will detail the age restrictions for STELARA based on its approved uses for inflammatory conditions.

Quick Summary

STELARA's age limit depends on the treated condition, with pediatric approval for plaque psoriasis and psoriatic arthritis starting at age 6. For Crohn's disease and ulcerative colitis, the drug is currently approved for adult patients only. Specific dosage considerations apply to children.

Key Points

  • Condition-Specific Age Limits: The approved age for STELARA varies depending on the specific inflammatory condition being treated.

  • Pediatric Use for Psoriasis and PsA: For moderate to severe plaque psoriasis and active psoriatic arthritis, STELARA is approved for children aged 6 years and older.

  • Adults Only for IBD: For inflammatory bowel diseases like Crohn's disease and ulcerative colitis, STELARA is currently limited to adult patients aged 18 and over.

  • Dosage based on weight for Children: For pediatric patients aged 6 and older, dosage is calculated based on body weight.

  • Professional Administration for Children: For patients under 18, it is recommended that STELARA injections be administered by a healthcare professional.

  • Ongoing Review: As of late 2025, applications were under review for potential expanded use of STELARA in younger patients for conditions like pediatric Crohn's disease.

In This Article

Before considering treatment with STELARA, it is important to understand that eligibility is determined not only by the specific medical condition but also by the patient's age. The U.S. Food and Drug Administration (FDA) has approved STELARA for various conditions, each with its own age requirements. Patients and caregivers should always consult with a healthcare provider to determine if STELARA is appropriate based on the patient's age and diagnosis. This section details the age limits for STELARA for its approved indications.

STELARA for Plaque Psoriasis

STELARA is approved by the FDA for the treatment of moderate to severe plaque psoriasis in adults and in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. Clinical studies, such as CADMUS and CADMUS Junior, have supported the use of STELARA in adolescents (ages 12–17) and younger children (ages 6–11). For adult patients with plaque psoriasis, there is no specific upper age limit for receiving STELARA, provided a healthcare provider assesses its safety and suitability.

STELARA for Psoriatic Arthritis

STELARA is also approved for the treatment of active psoriatic arthritis. This indication includes both adult patients aged 18 and older, as well as pediatric patients aged 6 years and older. STELARA can be used alone or in combination with methotrexate.

STELARA for Crohn's Disease and Ulcerative Colitis

For moderately to severely active Crohn's disease and ulcerative colitis, STELARA is currently indicated only for adult patients aged 18 years and older. While an application for pediatric use in Crohn's disease was pending with the FDA as of September 2025, there are no FDA-approved indications for the use of STELARA in pediatric patients with ulcerative colitis at this time.

Dosage Considerations for Pediatric Patients

When STELARA is used in pediatric patients aged 6 years and older, dosage is determined based on the child's body weight. This approach helps ensure that the appropriate amount of medication is administered for safety and effectiveness.

Here is a comparison of age eligibility and dosing considerations for different conditions:

Condition Minimum Age Pediatric Dosing Considerations Adult Dosing Considerations
Plaque Psoriasis 6 years old Dosage is weight-based. The medication is typically administered at specific intervals. Dosage may be weight-based. Administration follows a specific schedule.
Psoriatic Arthritis 6 years old Dosage is weight-based. Administration follows a specific schedule. Dosage may vary. Administration follows a specific schedule, potentially adjusted for certain factors.
Crohn's Disease 18 years old Not currently approved. Treatment involves an initial intravenous infusion, followed by subcutaneous injections at regular intervals.
Ulcerative Colitis 18 years old Not currently approved. Treatment involves an initial intravenous infusion, followed by subcutaneous injections at regular intervals.

Conclusion

The age limits for STELARA are condition-specific and must be evaluated by a medical professional. While children as young as six may be eligible for treatment for certain skin and joint conditions, the medication's use for inflammatory bowel diseases is currently limited to adults aged 18 and over. It is essential for prospective patients and their caregivers to have a detailed discussion with their doctor to review the safety and suitability of STELARA for their individual circumstances. Staying informed about the FDA-approved indications is crucial for making informed treatment decisions. For further information, including complete prescribing information and safety guidelines, the manufacturer's official website can serve as an authoritative resource.

Disclaimer:

This article provides general information and is not a substitute for medical advice. Always consult with a qualified healthcare professional before making any decisions about your treatment plan. The information on age limits and indications is based on FDA approvals and is subject to change.

Note: A healthcare provider must determine if STELARA is the right course of treatment for a patient and provide guidance on its administration.

Frequently Asked Questions

The minimum age for STELARA treatment for moderate to severe plaque psoriasis is 6 years old, following its FDA approval for pediatric patients in 2020.

No, STELARA is not currently approved for children with Crohn's disease. Its use for this condition is limited to adult patients aged 18 and older.

For active psoriatic arthritis, STELARA is approved for both adult patients (18 and older) and pediatric patients aged 6 years and older.

Yes, adolescents aged 12 to 17 can take STELARA for moderate to severe plaque psoriasis, and clinical studies have supported its efficacy and safety in this age group.

No, STELARA is not approved for treating ulcerative colitis in patients under 18. Its use for this condition is restricted to adult patients.

Yes, for pediatric patients aged 6 and older, the dosage of STELARA is based on the patient's body weight, which differs from dosage considerations for adult patients.

Yes, STELARA should only be used under the supervision of a healthcare provider. A doctor must evaluate the child's specific condition and health status to determine if STELARA is an appropriate and safe treatment.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Always consult a qualified healthcare provider regarding personal health decisions.