Evidence map›Paper›PMID 42414846›Full record

SynthesisClinical pharmacokinetics2026

Clinical Pharmacokinetics and Pharmacodynamics of the IL-1 Receptor Antagonist Anakinra: A Systematic Review.

Jia Li, Megan Clark, David K Metz, Marcel F Nold, Carl M J Kirkpatrick

Abstract readSystematic Review
In one paragraph

Synthesis in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jia LiMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Australia. jia.li1@monash.edu.ORCID http://orcid.org/0009-0009-8688-9878
Megan ClarkMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Australia.ORCID http://orcid.org/0000-0002-8391-1306
David K MetzMonash Children's Hospital, Melbourne, Australia.ORCID http://orcid.org/0000-0003-4478-5308
Marcel F NoldMonash Children's Hospital, Melbourne, Australia.ORCID http://orcid.org/0000-0001-9682-4618
Carl M J KirkpatrickMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Australia.ORCID http://orcid.org/0000-0002-5715-1534

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveAnakinra, an interleukin-1 receptor antagonist (IL-1Ra), has been used clinically for over 20 years, with growing interest in repurposing it across diverse indications. However, clinical dosing strategies for anakinra are variable, with limited pharmacokinetic (PK)/pharmacodynamic (PD) knowledge across patient populations and administration routes available. This systematic review aimed to summarise clinical PK and PD characteristics of anakinra and identify research gaps.

methodsA systematic search of Medline, Embase, and other databases was conducted to identify clinical studies reporting the PK, PD, efficacy, and safety of anakinra. Following the application of predefined inclusion and exclusion criteria, 26 articles were included in the review. Extracted data from these studies were converted into uniform units to enable cross-study comparison, and a descriptive synthesis was performed. All included studies were assessed for risk of bias.

resultsData were categorised into three groups: noncompartmental analysis (NCA) PK parameters, model-informed PK/PD parameters, and exposure-response (ER) relationships. Across all studies, anakinra demonstrated linear PK following both intravenous (IV) and subcutaneous (SC) administration, with high SC bioavailability and flip-flop kinetics. Covariate analyses from NCA and PK models consistently identified body weight and renal function as key determinants of anakinra PK variability, with clearance increasing with body weight and decreasing with worsening renal function. ER analyses identify a potential target exposure corresponding to an average steady-state concentration (C

conclusionsOverall, this review highlights substantial gaps in the clinical PK/PD knowledge on anakinra, and model robustness. Future studies, integrating physiologically informed covariates, improved biomarker strategies, and comprehensive ER data, are essential to support model-informed dosing for anakinra repurposing across populations and administration routes. These would facilitate the safety and efficacy of anakinra therapy across diverse populations.

Indexed as

Antirheumatic AgentsInterleukin 1 Receptor Antagonist ProteinDose-Response Relationship, DrugHumansInjections, SubcutaneousModels, BiologicalAntirheumatic AgentsInterleukin 1 Receptor Antagonist Protein

Identifiers

PMID42414846
PMCPMC13461743

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.