Evidence map›Paper›PMID 42791567›Full record

ArticleClinical pharmacology and therapeutics2026

Model-Informed Dose Optimization of Anakinra in Preterm Neonates Implications for Safe and Effective Dosing.

Jia Li, David K Metz, Elys Green, Gergely Toldi, Robert Galinsky, Megan Clark, Rebecka Atkinson, Ina Rudloff, Josephine C Owen, Sara K DiSimone and 18 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05280340 (Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05280340 phase1 / phase2active not recruitingnot on this map

Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot

TypeinterventionalSponsorMonash Medical CentreRan2022 to 2025Enrolled25ConditionsPrematurity, Extreme, InflammationArmsAnakinra
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

28 authors.

Jia LiMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0009-0009-8688-9878
David K MetzDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0003-4478-5308
Elys GreenDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.
Gergely ToldiLiggins Institute, University of Auckland, Auckland, New Zealand.ORCID https://orcid.org/0000-0003-0178-1243
Robert GalinskyRitchie Centre, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-6374-9372
Megan ClarkMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-8391-1306
Rebecka AtkinsonMonash Children's Hospital, Melbourne, Victoria, Australia.ORCID https://orcid.org/0009-0009-2133-381X
Ina RudloffDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-7885-110X
Josephine C OwenDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0009-0002-7599-994X
Sara K DiSimoneDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.
Samuel C ForsterCentre for Innate Immunity and Infectious Disease, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0003-4144-2537
Steven X ChoDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-4057-2092
Atif MajidLiggins Institute, University of Auckland, Auckland, New Zealand.
Graeme R PolglaseDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-8906-614X
Marcel FavillaMonash Children's Hospital, Melbourne, Victoria, Australia.
Pramod PharandeDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-3251-1417
Atul MalhotraDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-9664-4182
Calum T RobertsDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-9111-5027
Scott H StansfieldMonash Children's Hospital, Melbourne, Victoria, Australia.
Arvind SehgalDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0003-2600-7529
Kenneth TanDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1931-0549
Alistair J GunnDepartment of Physiology, The University of Auckland, Auckland, New Zealand.ORCID https://orcid.org/0000-0003-0656-7035
Philip J BergerRitchie Centre, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.
Alex VeldmanDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.
Rod W HuntDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-2446-1739
Claudia A Nold-PetryDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-7439-3834
Marcel F NoldDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-9682-4618
Carl M J KirkpatrickMonash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-5715-1534

Funding

Catalyst: Seeding General (NZ) 22-UOA-071-CSGHealth Research Council of New Zealand 22/559NHMRC APP1173584NHMRC APP1173731NHMRC APP1175634NHMRC APP 2033196Royal Society of New Zealand CSG-UOA2209
6 · The paper itself

Abstract

Anakinra, an interleukin-1 receptor antagonist, shows promise for reducing inflammatory complications of premature birth. However, the pharmacokinetics (PK) of anakinra in neonates has not been characterized, limiting evidence-based dosing. This study aimed to develop a population PK model for anakinra to guide dosing in preterm neonates. Data from 25 preterm neonates (median gestational age: 26.3 weeks) from a Phase I/IIa trial of intravenous anakinra (Anakinra Pilot, NCT05280340) were analyzed, with 4-8 samples collected per neonate across 0-20 days postnatal age (PNA). A population PK model was developed and dosing simulations were performed incorporating a pharmacodynamic (PD) direct effect model (I

Identifiers

PMID42791567
PMCPMC13615173

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Registered trials

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.