Age Restrictions for Risankizumab Use
Risankizumab is NOT approved for use in pediatric patients at any age—the FDA explicitly states that "the safety and effectiveness of SKYRIZI have not been established in pediatric patients." 1
FDA-Approved Age Indication
- Risankizumab is approved exclusively for adult patients with moderate-to-severe plaque psoriasis 1
- There is no lower age cutoff specified within the adult population, meaning it can be used in adults 18 years and older 1
- The FDA label contains no data on pediatric safety or efficacy, making off-label use in children unsupported by regulatory approval 1
Contrast with Other Biologics
This represents a key difference from some other biologics used in psoriasis:
- Etanercept is FDA-approved for pediatric patients as young as 4 years of age for plaque psoriasis 2
- In pediatric studies, etanercept demonstrated that 57% of children aged 4-17 years achieved PASI-75 when dosed at 0.8 mg/kg weekly 2
- Adalimumab is also approved for use in patients as young as 4 years for various inflammatory conditions 2
Clinical Trial Data Limitations
The absence of pediatric approval reflects the lack of clinical trial data in younger populations:
- Clinical trials of risankizumab enrolled only adult patients 2, 3, 4, 5
- Long-term safety data extending through 6 years (324 weeks) included only adult subjects 3
- The 6,862 subjects exposed to risankizumab across all indications included no pediatric patients 1
Geriatric Use
At the upper end of the age spectrum, risankizumab can be used without age-related restrictions in older adults:
- No dose adjustment is required for geriatric patients 1
- Clinical studies included 664 patients aged 65 years or older and 71 patients aged 75 years or older 1
- No clinically meaningful differences in pharmacokinetics were observed based on age 1
- The American Academy of Dermatology provides Grade A recommendations for risankizumab use in adults without upper age limitations 6
Practical Implications
For clinical practice, this means risankizumab should only be prescribed to patients 18 years of age or older. For pediatric patients with moderate-to-severe plaque psoriasis requiring biologic therapy, alternative agents with established pediatric safety profiles (such as etanercept) should be considered instead 2.