Golimumab (Simponi) Dosing for Pediatric Patients According to BNFC
The recommended dose of golimumab (Simponi) for pediatric patients with polyarticular juvenile idiopathic arthritis according to evidence is 30 mg/m² of body surface area (maximum 50 mg) administered subcutaneously every 4 weeks.
Dosing Recommendations
For Polyarticular Juvenile Idiopathic Arthritis (pJIA)
- Dose: 30 mg/m² of body surface area
- Maximum dose: 50 mg per dose
- Frequency: Every 4 weeks
- Administration route: Subcutaneous injection
This dosing regimen is supported by clinical evidence from a multicenter, double-blind, randomized-withdrawal trial that demonstrated efficacy and safety in children with active polyarticular-course juvenile idiopathic arthritis 1.
Clinical Efficacy
The recommended dosing regimen has shown significant clinical benefits:
- 89.0% of patients achieved JIA ACR30 response
- 79.2% achieved JIA ACR50 response
- 65.9% achieved JIA ACR70 response
- 36.4% achieved JIA ACR90 response 1
Safety Considerations
Golimumab is generally well-tolerated in the pediatric population with:
- Injection site reactions occurring in <1% of all injections
- No unexpected safety events reported in clinical trials 1
- Similar adverse event rates compared to placebo in controlled studies
Monitoring Recommendations
- Regular assessment of clinical response
- Monitoring for signs of infection
- Tuberculosis screening prior to initiation
- Periodic assessment of liver function tests
- Evaluation for development of antibodies if loss of response occurs
Special Considerations
For Severe Pediatric Crohn's Disease
In patients with severe pediatric Crohn's disease who have failed other TNF-α inhibitors, dose escalation may be required:
- Some patients may need dosing intervals shortened from every 4 weeks to every 2 weeks to maintain therapeutic response 2
- Monitoring of drug levels is advisable when using golimumab in patients previously exposed to other TNF-α inhibitors
Concomitant Medications
- Golimumab can be administered with methotrexate for enhanced efficacy in JIA 1
- When used with other immunosuppressants, increased vigilance for infections is warranted
Practical Implementation
- Calculate body surface area accurately to determine the appropriate dose
- Ensure proper training for subcutaneous administration technique
- Store medication as directed in product information
- Consider the patient's weight and age when determining the appropriate dose
While the evidence primarily supports the use of golimumab in polyarticular JIA, limited evidence suggests it may also be considered as an alternative treatment option in pediatric patients with severe Crohn's disease who have failed other TNF-α inhibitors, though response rates may be suboptimal in these previously exposed patients 2.