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Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
Published on: September 16, 2017
Safety of TNF inhibitors in adolescents and children
1Clinical Pharmacy, Philadelphia College of Pharmacy, Philadelphia, PA, USA.
Insights
Tumor necrosis factor (TNF) inhibitors, used for pediatric conditions like Crohn
Area of Science:
- Pediatric Rheumatology and Gastroenterology
- Pharmacology and Therapeutics
- Immunology
Background:
- Tumor necrosis factor (TNF) inhibitors are increasingly utilized in pediatric care for conditions such as Crohn's disease and juvenile idiopathic arthritis.
- While effective, the comprehensive safety profile of these agents in children remains incompletely understood.
- Adverse effects observed in adults, including infections, malignancies, and demyelinating disorders, raise concerns for pediatric populations.
Purpose of the Study:
- To review the use and pharmacology of TNF inhibitors in children.
- To summarize current safety data for etanercept, adalimumab, and infliximab in pediatric patients.
- To assess the known risks and benefits of TNF inhibitors for pediatric indications.
Main Methods:
- Review of existing literature on TNF inhibitor use in children.
- Analysis of safety data from clinical trials and case reports.
- Comparison of adverse event profiles between pediatric and adult populations.
Main Results:
- TNF inhibitors are associated with an increased risk of malignancy, particularly lymphoma, in children.
- Pediatric patients exhibit an elevated rate of infections, including rare and opportunistic types, similar to adults.
- Infusion or injection-site reactions occur, with infliximab showing a lower rate of infusion reactions in children compared to adults.
Conclusions:
- Due to limited long-term safety data, TNF inhibitors in children should be reserved for refractory cases.
- Thorough risk assessment and patient/parental understanding are crucial before initiating TNF inhibitor therapy.
- Ongoing monitoring is essential to fully elucidate the long-term safety of these agents in pediatric populations.
Abstract:
This article describes the use of tumor necrosis factor (TNF) inhibitors in children, reviews the pharmacology of these agents, and reviews and summarizes the current safety information available for etanercept, adalimumab, and infliximab. TNF inhibitors are being used for a variety of indications in children including Crohn's disease and juvenile idiopathic arthritis. However, the full safety profile of these agents is still not known. In adult patients, TNF inhibitors have demonstrated a variety of adverse effects including increased risk of infection, malignancy, demyelinating disorders, and reactivation of latent diseases. In children the rate of adverse effects is harder to elucidate due to the limited number of patients in clinical trials and limited case reports. However, based on the data available, TNF inhibitors have been implicated in increasing the rate of malignancy in children, especially the rate of lymphoma. In addition, similarly with adults the rate of infections is increased and the types of infections are more rare or opportunistic. One of the more common adverse effects continues to be infusion or injection-site reactions, although children tend to have a lower rate of infusion reactions with infliximab compared to adults. Based on the limited safety information and long-term effect data, TNF inhibitors should be reserved in children for patients with refractory disease and the risks need to be understood and assessed prior to initiation.
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