Evidence map›Paper›PMID 23053683›Full record

Trial reportClinical rheumatology2012

Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan.

Tomoyuki Imagawa, Syuji Takei, Hiroaki Umebayashi, Kenichi Yamaguchi, Yasuhiko Itoh, Toshinao Kawai, Naomi Iwata, Takuji Murata, Ikuo Okafuji, Mari Miyoshi and 10 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical rheumatology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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  6. Article
  7. Article
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  9. Article
  10. Observational
  11. Tuberculosis in children and adolescents with rheumatic diseases using biologic agents: an integrative review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2023
    Review
  12. Article
  13. Article
  14. Article
  15. Biotherapies in Uveitis.Journal of clinical medicine · 2020
    Review
  16. Article
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  20. Observational
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

20 authors at 16 institutions in 4 countries.

Tomoyuki ImagawaYokohama City University, Japan. timagawa@ca2.so-net.ne.jp
Syuji Takei
Hiroaki Umebayashi
Kenichi Yamaguchi
Yasuhiko Itoh
Toshinao Kawai
Naomi Iwata
Takuji Murata
Ikuo Okafuji
Mari Miyoshi
Yasuhiro Onoe
Yoshifumi Kawano
Noriko Kinjo
Masaaki Mori
Neelufar Mozaffarian
Hartmut Kupper
Sourav Santra
Gina Patel
Shinichi Kawai
Shumpei Yokota
Yokohama City University · JPAbbott Fund · USAbbott (Germany) · DEGlaxoSmithKline (India) · INKagoshima University · JPKagoshima University Hospital · JPKobe Children's Hospital · JPKobe City Medical Center General Hospital · JPMiyagi Children's Hospital · JPNational Center For Child Health and Development · JPNational Hospital Organization · JPNippon Medical School Hospital · JPOsaka Medical and Pharmaceutical University · JPSt. Luke's International Hospital · JPToho University · JPUniversity of the Ryukyus University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study was to evaluate the efficacy, pharmacokinetics, and safety of adalimumab in patients with polyarticular juvenile idiopathic arthritis (JIA) in Japan. Patients aged 4 to 17 years were enrolled in a single-arm, open-label, multicentre study of adalimumab. Patients weighing <30 kg received 20 mg every other week (eow), and those ≥30 kg received 40 mg eow. Concomitant methotrexate (MTX) was allowed (≤10 mg/m(2) per week). The primary efficacy outcome was the percent of patients with American College of Rheumatology Pediatric 30 response (ACR Pedi 30) at week 16. JIA core variables, serum adalimumab concentrations, and anti-adalimumab antibodies (AAAs) were analysed. Patients were monitored for adverse events (AEs). Twenty-five patients (20 with concomitant MTX at baseline and 5 without) were enrolled: 24 patients completed 16 weeks of therapy and 22 patients completed 60 weeks. At week 16, 90 % of patients with MTX and 100 % without MTX achieved ACR Pedi 30; response rates were maintained through week 60 in 94 and 80 % of patients, respectively. Each JIA core variable improved over time. Six patients became AAA positive (two each at weeks 8, 16, and 60), some of which were transient. All six AAA-positive patients achieved ACR Pedi 30 at week 16, and four maintained that response at week 60. Six patients (all with MTX) experienced nine serious AEs (JIA, pyrexia, arthralgia, pneumonia, hepatitis B infection, pharyngitis, dehydration, pharyngeal pain, and pneumonia). In pediatric patients with polyarticular JIA in Japan, adalimumab was safe and effective for reducing disease activity for up to 60 weeks.

Indexed as

AdalimumabAdolescentAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, JuvenileChildChild, PreschoolDrug Therapy, CombinationFemaleHumansJapanMaleMethotrexateTreatment OutcomeTumor Necrosis Factor-alphaAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexateTumor Necrosis Factor-alpha

Identifiers

PMID23053683
PMCPMC3505492
OpenAlexW2032008287

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.