Objective:

To inform about the FDA approval of risankizumab for pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis.

Approach:

• Approval Details: Risankizumab (Skyrizi) is approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis.
• Dosing Information: Includes a 55-mg prefilled syringe for patients weighing less than 40 kg; the existing 150-mg syringe remains for those weighing 40 kg or greater.
• Clinical Trial Support: The pediatric plaque psoriasis indication is supported by the phase 3 OptIMMize clinical trial program.
• Safety Profile: The safety profile in pediatric patients is consistent with that observed in adults.

Key Findings:

• Approximately 30% of psoriasis cases begin before age 18.
• About 20,000 children under 10 are diagnosed with psoriasis annually in the US.
• Approximately 14,000 children are affected by psoriatic arthritis.

Interpretation:

Limitations:

• Risankizumab may cause serious allergic reactions and infections.
• Patients should be screened for infections and tuberculosis before treatment.

Conclusion:

Sources:

• AbbVie Press Release