Safety profile of TNF- alpha Inhibitors in pediatric patients: A post-marketing surveillance study based on the FAERS database
These videos have been matched automatically. Contact us if they are not relevant.
These videos have been matched automatically. Contact us if they are not relevant.
![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [<sup></noscript>18</sup>F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](https://visualize.jove.com/wp-content/cache/webp/006cd0e0e182faab6215d99044f631fd.webp)
View abstract on PubMed
Summary
This summary is machine-generated.Pediatric patients using tumor necrosis factor-alpha (TNF-α) inhibitors experienced infection and injection-site reactions. Enhanced monitoring is recommended to manage adverse events and optimize treatment benefits.
Area Of Science
- Pediatric Pharmacology
- Immunology
- Pharmacovigilance
Background
- Tumor necrosis factor-alpha (TNF-α) inhibitors are crucial for managing pediatric chronic inflammatory diseases.
- Understanding their safety profile in pediatric populations is essential for clinical practice.
Purpose Of The Study
- To systematically evaluate the safety profile of TNF-α inhibitors in pediatric patients.
- To identify significant adverse event (AE) signals and patterns associated with these therapies.
Main Methods
- Utilized data from the U.S. FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024.
- Conducted disproportionality analysis of AE reports for specific TNF-α inhibitors (infliximab, etanercept, adalimumab, golimumab, certolizumab).
Main Results
- Identified 852 significant safety signals across 27 system organ classes (SOCs).
- Predominant concerns included infection-related AEs and injection-site reactions.
- A significant proportion of AEs required hospitalization (25.5%), with rare fatal (0.9%) or life-threatening (1.4%) outcomes.
Conclusions
- TNF-α inhibitors are associated with multisystemic adverse events in pediatric patients, often with prolonged latency.
- Enhanced clinical vigilance, including infection surveillance and site evaluations, is recommended.
- A tiered monitoring protocol can optimize the risk-benefit ratio for these vital therapies.
These videos have been matched automatically. Contact us if they are not relevant.
These videos have been matched automatically. Contact us if they are not relevant.
Related Concept Videos
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...