Evidence map›Paper›PMID 24487484›Full record

Trial reportClinical rheumatology2014

Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years.

Daniel J Kingsbury, Brigitte Bader-Meunier, Gina Patel, Vipin Arora, Jasmina Kalabic, Hartmut Kupper

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Clinical rheumatology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
3.7field-weighted citation impact, top 6% of its field
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

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis.The Cochrane database of systematic reviews · 2025
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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

6 authors at 4 institutions in 3 countries.

Daniel J KingsburyRandall Children's Hospital at Legacy Emanuel, 501 N Graham, Suite 355, Portland, OR, 97227, USA, dkingsbu@lhs.org.
Brigitte Bader-Meunier
Gina Patel
Vipin Arora
Jasmina Kalabic
Hartmut Kupper
AbbVie (Germany) · DEAbbVie (United States) · USHôpital Necker-Enfants Malades · FRRandall Children's Hospital at Legacy Emanuel · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study was to assess the safety of adalimumab in patients aged 2 to <4 years old or ≥4 years old weighing <15 kg with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Clinical effectiveness and pharmacokinetics (PK) of adalimumab were also evaluated. This was an international, multicenter, open-label, phase 3b study in 32 patients with active JIA that were treated with adalimumab 24 mg/m(2) (maximum = 20 mg/dose) every other week up to 120 weeks, with or without concomitant methotrexate. Adverse events (AEs) were summarized for completed visits. Efficacy endpoints included American College of Rheumatology pediatric (PedACR) 30/50/70/90 responses and JIA core components. Adalimumab serum trough concentrations were measured in a subset of patients. Among the patients, 88 % were female. Baseline mean age, weight, and JIA duration were 3 years, 13 kg, and 12 months, respectively; 39 % had elevated C-reactive protein. AE incidence rates included any AEs (29/32, 91 %), serious AEs (5/32, 16 %), infectious AEs (25/32, 78 %), and serious infections (3/32, 9 %). No deaths, malignancies, or opportunistic infections were reported. Growth was not adversely impacted. At week 96, 92 % of patients achieved PedACR30, and 77 % achieved PedACR70. Improvements in JIA core components were observed. Mean steady-state serum adalimumab trough concentrations were 7-8 μg/mL at weeks 12 and 24. Adalimumab was well tolerated in JIA patients aged 2 to <4 years old or ≥4 years old weighing <15 kg. The efficacy and PK of adalimumab were comparable to those seen in older JIA patients.

Indexed as

AdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, JuvenileBiomarkersChild, PreschoolC-Reactive ProteinDose-Response Relationship, DrugDrug Therapy, CombinationEuropeFemaleHumansInternational CooperationMaleMethotrexateTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkersC-Reactive ProteinMethotrexate

Identifiers

PMID24487484
PMCPMC4161937
OpenAlexW2035913022

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.