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Systematic Review of Adverse Events of IL-1 and IL-6 Inhibitor Use in Pediatrics
Amandi Perera1, Nikita Chugh1, Facundo Garcia-Bournissen1
1Schulich School of Medicine and Dentistry (AP, NC, FG-B), Western University, Department of Pediatrics (FG-B), Western University, London, Ontario, Canada.
Insights
This review found that infections and injection site reactions are common adverse events in children using interleukin-1 (IL-1) and interleukin-6 (IL-6) inhibitors. Serious adverse events occurred in 25% of pediatric patients, highlighting the need for careful risk-benefit consideration.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Pharmacology
Background:
- Interleukin-6 (IL-6) and Interleukin-1 (IL-1) inhibitors are potent biologics increasingly used in pediatric care.
- The safety profile of these advanced therapies in children requires thorough investigation due to their relatively recent introduction.
Purpose of the Study:
- To systematically review the literature and elucidate the adverse event risks associated with IL-1 and IL-6 inhibitor use in pediatric populations.
- To identify common and serious adverse events in children treated with these biologic agents.
Main Methods:
- A comprehensive systematic literature search was performed, including English-language clinical studies of pediatric patients receiving IL-1 or IL-6 inhibitors.
- Two independent reviewers screened abstracts and full texts based on predefined criteria, with conflicts resolved by a third reviewer.
- Data extraction focused on intervention details, adverse events, and their frequencies.
Main Results:
- Out of 2707 screened studies, 38 were included, analyzing data from specific drugs like canakinumab, anakinra, rilonacept, and tocilizumab.
- Common adverse events reported were infections, injection site reactions, headache, fever, arthralgia, and rash.
- A significant rate of 25% (557 events in 2208 patients) for serious adverse events was observed.
Conclusions:
- The use of IL-1 and IL-6 inhibitors in pediatric patients necessitates a careful balance between immunosuppressive benefits and potential risks.
- Limited data currently exist regarding the long-term safety and follow-up of children treated with these biologic therapies.
Objective:
Two, relatively new and potent, classes of biologicals are interleukin-6 (IL-6) and interleukin-1 (IL-1) inhibitors. As the use of these biologicals in children is more recent, the nature and incidence of adverse effects in the pediatric population are less well known. We systematically reviewed the available literature to elucidate the risks of IL-1 and IL-6 inhibitor use in the pediatric population.
Methods:
A systematic literature search was conducted including English-language clinical studies of children who received IL-1 or IL-6 inhibitors for therapeutic purposes. Abstracts and full-text screening of manuscripts were carried out by 2 independent reviewers, based on predefined eligibility criteria. Any conflicts between the 2 reviewers were resolved by a third reviewer. Data extracted included characteristics such as intervention (drug, dose, method of administration, frequency), adverse events, and frequency of adverse events.
Results:
A total of 2707 studies were screened and 38 studies were selected for inclusion. Of these 38 studies, 9 involved canakinumab, 12 involved anakinra, 2 involved rilonacept, 15 involved tocilizumab, and 1 involved an unspecified recombinant IL-6 antagonist. The most common adverse events included infection, local injection site reactions, headache, fever, arthralgia, and rash. There were 557 serious adverse events reported in 2208 patients (rate = 25%).
Conclusions:
Risks of biological use should be considered alongside the immunosuppressive benefits when prescribing IL-1 and IL-6 inhibitors in the pediatric population. Few data were available on long-term follow-up of these patients.
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