Evidence map›Paper›PMID 39972375›Full record

ArticlePediatric rheumatology online journal2025

Safety and effectiveness of intravenous abatacept for polyarticular-course juvenile idiopathic arthritis: An all-case postmarketing surveillance study.

Tomo Nozawa, Naomi Iwata, Toru Igarashi, Ichiro Kobayashi, Shoji Ota, Takako Yamada, Etsuya Bando, Katsuyoshi Habiro, Syuji Takei

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In one paragraph

Article in Pediatric rheumatology online journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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

5 · Who and what money

Authors and funding

9 authors.

Tomo NozawaDepartment of Pediatrics, Yokohama City University Graduate School of Medicine, Yokohama, Japan. tnozawa@yokohama-cu.ac.jp.
Naomi IwataDepartment of Infection and Immunology, Aichi Children's Health and Medical Center, Obu, Japan.
Toru IgarashiDepartment of Pediatrics, Nippon Medical School, Tokyo, Japan.
Ichiro KobayashiCenter for Pediatric Allergy and Rheumatology, KKR Sapporo Medical Center, Sapporo, Japan.
Shoji OtaBristol Myers Squibb, Tokyo, Japan.
Takako YamadaBristol Myers Squibb, Tokyo, Japan.
Etsuya BandoBristol Myers Squibb, Tokyo, Japan.
Katsuyoshi HabiroBristol Myers Squibb, Tokyo, Japan.
Syuji TakeiFaculty of Medicine, School of Health Sciences, Kagoshima University, Kagoshima, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 2018, intravenous abatacept was approved for the treatment of refractory polyarticular-course juvenile idiopathic arthritis (JIA) in Japan. However, reports describing the effectiveness and safety of abatacept in clinical practice in Japanese patients with refractory polyarticular-course JIA are limited. Therefore, this postmarketing surveillance study aimed to evaluate the real-world safety and effectiveness of abatacept in Japanese pediatric patients with refractory polyarticular-course JIA.

methodsThis study evaluated patients included in an all-case postmarketing surveillance study between February 2018 and August 2020 who were treated with intravenous abatacept. Data on the safety and effectiveness of the registered patients were collected during the 52-week follow-up period. Disease activities were evaluated using Juvenile Arthritis Disease Activity Score 27 (JADAS-27). The effect of abatacept on a child's growth was assessed using the height and weight standard deviation scores (SDS).

resultsA total of 82 patients were registered in this study, of whom 14.6% and 85.4% were males and females, respectively. The proportion of patients with oligoarticular, rheumatoid factor (RF)-negative polyarticular, and RF-positive polyarticular JIA was 12.2, 28.0, and 54.9%, respectively. The incidence of adverse drug reactions (ADRs) and serious ADRs was 22.0% and 2.4%, respectively. During the study period, 64.7% of the patients achieved JADAS-27 low disease activity or less. A significant difference in JADAS-27 scores in patients with RF-positive polyarticular JIA was observed between baseline and 24 or 52 weeks after abatacept administration. The height and weight SDS tended to improve during abatacept treatment.

conclusionsAbatacept is effective in polyarticular-course JIA, particularly in RF-positive patients, and in restoring a child's growth. Additionally, the incidence of ADRs is similar to that observed in the clinical trial. The results of the study suggest that abatacept is a useful therapeutic option for treating refractory polyarticular-course JIA in real-world settings in Japan.

Indexed as

AbataceptAntirheumatic AgentsArthritis, JuvenileAdministration, IntravenousAdolescentChildChild, PreschoolFemaleHumansJapanMaleProduct Surveillance, PostmarketingTreatment OutcomeAbataceptAntirheumatic AgentsAbataceptGrowth retardationJuvenile Arthritis Disease Activity Score 27Polyarticular-course juvenile idiopathic arthritisPostmarketing surveillance studyStandard deviation score

Identifiers

PMID39972375
PMCPMC11841336

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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.