What is the dose of adalimumab (Humira) in pediatric patients?

From the Guidelines

The dose of adalimumab for pediatric patients is 0.8 mg/kg (maximum, 40 mg) at weeks 0 and 1 and then is given every other week, as recommended by the joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients 1.

Key Considerations

• The dosing regimen may vary depending on the specific indication, such as juvenile idiopathic arthritis, Crohn's disease, or ulcerative colitis.
• Weight-based dosing is used, with adjustments made based on the patient's weight and clinical response.
• Adalimumab is administered subcutaneously, and patients or caregivers should be trained on proper injection technique.
• Regular monitoring for adverse effects, including infection risk, is essential, and dose adjustments may be necessary based on clinical response and tolerability.

Indication-Specific Dosing

• For pediatric plaque psoriasis, the recommended dose is 0.8 mg/kg (maximum, 40 mg) at weeks 0 and 1 and then every other week 1.
• For juvenile idiopathic arthritis, children 2 years and older weighing 10 kg to less than 15 kg receive 10 mg every other week; those weighing 15 kg to less than 30 kg receive 20 mg every other week; and those weighing 30 kg or more receive 40 mg every other week 1.

Important Safety Considerations

• Patients and their households should be monitored for infection during treatment, and vaccinations should be up to date before initiating treatment 1.
• Baseline monitoring for biologic therapy includes testing for latent tuberculosis, hepatitis, and HIV screening, as well as regular history and physical examinations to monitor for infection 1.

From the FDA Drug Label

The adalimumab mean steady-state trough concentrations were 6.8 mcg/mL and 10. 9 mcg/mL in patients weighing <30 kg receiving 20 mg adalimumab subcutaneously every other week as monotherapy or with concomitant MTX, respectively. The adalimumab mean steady-state trough concentrations were 6.6 mcg/mL and 8. 1 mcg/mL in patients weighing ≥30 kg receiving 40 mg adalimumab subcutaneously every other week as monotherapy or with MTX concomitant treatment, respectively. The adalimumab mean steady-state trough adalimumab concentrations were 6.0 mcg/mL and 7. 9 mcg/mL in patients receiving adalimumab subcutaneously every other week as monotherapy or with MTX concomitant treatment, respectively.

The dose of adalimumab in pediatric patients is:

• For patients weighing <15 kg or 2 years to <4 years of age: the dose is not explicitly stated, but the mean steady-state trough concentrations were 6.0 mcg/mL and 7.9 mcg/mL.
• For patients weighing <30 kg: 20 mg every other week.
• For patients weighing ≥30 kg: 40 mg every other week.
• For patients with pediatric Crohn's disease:
  • Weighing ≥40 kg: 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every other week for maintenance.
  • Weighing <40 kg: 80 mg at Week 0 and 40 mg at Week 2, followed by 20 mg every other week for maintenance. 2 2

From the Research

Dose of Adalimumab in Pediatric Patients

The dose of adalimumab in pediatric patients varies based on weight and the specific condition being treated.

• For patients with juvenile idiopathic arthritis (JIA) associated uveitis, the dose is 20 mg/0.8 ml for patients <30 kg or 40 mg/0.8 ml for patients weighing 30 kg or more, administered via subcutaneous injection every 2 weeks 3.
• In patients with polyarticular JIA, those weighing <30 kg receive 20 mg every other week, and those ≥30 kg receive 40 mg every other week 4.
• For children with polyarticular JIA aged 2 to <4 years or ≥4 years old weighing <15 kg, the dose is 24 mg/m(2) (maximum = 20 mg/dose) every other week 5.
• In the treatment of uveitis in childhood, doses of 20-40 mg every 2 weeks have been used, with some patients requiring weekly administration for effectiveness 6.
• In patients with JIA refractory to etanercept and/or infliximab, adalimumab has been used at a dose of 24 mg/m2/week concomitantly with methotrexate 7.

Administration and Considerations

It's important to note that these doses are based on specific studies and may not be universally applicable.

• Administration is typically via subcutaneous injection.
• The decision to use adalimumab and the appropriate dose should be made by a healthcare professional, taking into account the individual patient's condition, weight, and response to treatment.
• Concomitant use of methotrexate is common in the treatment of JIA and may affect the dosing of adalimumab.
• Monitoring for adverse events, including infections and changes in liver enzymes, is crucial during treatment with adalimumab 3, 4, 5, 6, 7.