Trial reportBMC pharmacology & toxicology2013
Anakinra pharmacokinetics in children and adolescents with systemic-onset juvenile idiopathic arthritis and autoinflammatory syndromes.
Trial report in BMC pharmacology & toxicology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Clinical Pharmacokinetics and Pharmacodynamics of the IL-1 Receptor Antagonist Anakinra: A Systematic Review.Clinical pharmacokinetics · 2026Pooled it
- Management of adult-onset Still's disease with interleukin-1 inhibitors: evidence- and consensus-based statements by a panel of Italian experts.Arthritis research & therapy · 2019Pooled it
- Anakinra in Sanfilippo syndrome: a phase 1/2 trial.Nature medicine · 2024Trial
- Anakinra Pilot - a clinical trial to demonstrate safety, feasibility and pharmacokinetics of interleukin 1 receptor antagonist in preterm infants.Frontiers in immunology · 2022Trial
- Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis.British journal of clinical pharmacology · 2015Trial
- Model-Informed Dose Optimization of Anakinra in Preterm Neonates Implications for Safe and Effective Dosing.Clinical pharmacology and therapeutics · 2026Article
- Dose Exploration Based on Quantitative Pharmacokinetic Analysis of Monoclonal Antibodies for Pediatric Immune-Mediated Diseases: Current Evidence and Future Directions.Drug design, development and therapy · 2026Review
- Physiologically Based Pharmacokinetic Modelling in Critically Ill Children Receiving Anakinra While on Extracorporeal Life Support.Clinical pharmacokinetics · 2024Article
- The Role of Cytokines in the Pathogenesis and Treatment of Alcoholic Liver Disease.Diseases (Basel, Switzerland) · 2024Review
- Autoantibody-Mediated Depletion of IL-1RA in Still's Disease and Potential Impact of IL-1 Targeting Therapies.Journal of clinical immunology · 2024Article
- Clonal hematopoiesis related TET2 loss-of-function impedes IL1β-mediated epigenetic reprogramming in hematopoietic stem and progenitor cells.Nature communications · 2023Article
- Efficacy and safety of emapalumab in macrophage activation syndrome.Annals of the rheumatic diseases · 2023Article
- Design of a multicenter randomized clinical trial for treatment of Alcohol-Associated Hepatitis.Contemporary clinical trials communications · 2023Article
- Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis.Paediatric drugs · 2022Article
- Anakinra in Paediatric Rheumatology and Periodic Fever Clinics: Is the Higher Dose Safe?Frontiers in pediatrics · 2022Article
- The Trilogy of SARS-CoV-2 in Pediatrics (Part 2): Multisystem Inflammatory Syndrome in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Pharmacotherapy of Acute COVID-19 Infection and Multisystem Inflammatory Syndrome in Children: Current State of Knowledge.Pediatric allergy, immunology, and pulmonology · 2020Review
- New Medications Are Needed for Children With Juvenile Idiopathic Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2020Article
- Precision multiparameter tracking of inflammation on timescales of hours to years using serial dried blood spots.Bioanalysis · 2020Article
- Development and Application of a Physiologically-Based Pharmacokinetic Model to Predict the Pharmacokinetics of Therapeutic Proteins from Full-term Neonates to Adolescents.The AAPS journal · 2020Article
Corrections and comments
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Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnakinra pharmacokinetics and pharmacodynamics were investigated in children and adolescents treated for systemic-onset juvenile idiopathic arthritis (SJIA) and autoinflammatory syndromes.
methodsAnakinra was given subcutaneously at doses between 2 and 10 mg/kg (maximum 100 mg) per day. Anakinra concentrations were recorded in patients, as well as C-reactive protein (CRP) levels, on different occasions. The data were fitted to a pharmacokinetic-pharmacodynamic model via a population approach using Monolix.
resultsA total of 87 children and adolescents, 8 months to 21 years old, were available for pharmacokinetic evaluation. A one compartment model with linear absorption and elimination described the pharmacokinetics. Taking into account bodyweight to explain variations in apparent clearance (CL/F) and distribution volume (V/F) significantly reduced the associated between-subject and between-occasion variabilities. The final estimates were 6.24 L/h/70 kg and 65.2 L/70 kg for CL/F and V/F respectively. A mixture pharmacodynamic model described the CRP level change during anakinra treatment for the SJIA patients with 2 subpopulations, patients with high baseline and large CRP decrease and patients with low baseline and small CRP decrease followed by a re-increase in CRP levels. There was no significant effect of the combined anti-inflammatory treatment. The proportion of patients for which the development of a resistance to treatment was significant was 62% and the corresponding time was approximately 60 days.
conclusionsBased on effects in SJIA, a prospective dosage adjustment was proposed based on a 0.4 mg/L Css target in order to obtain a CRP decrease to 10 mg/L or below.
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