Evidence map›Paper›PMID 31039807›Full record

Trial reportPediatric rheumatology online journal2019

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.

Ryoki Hara, Hiroaki Umebayashi, Syuji Takei, Nami Okamoto, Naomi Iwata, Yuichi Yamasaki, Yasuo Nakagishi, Toshitaka Kizawa, Ichiro Kobayashi, Tomoyuki Imagawa and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric rheumatology online journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01835470 (A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT01835470 phase3completednot on this map

A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics

TypeinterventionalSponsorBristol-Myers SquibbRan2013 to 2018Enrolled23ConditionsJuvenile Idiopathic ArthritisArmsAbatacept
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

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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

16 authors at 12 institutions in 1 country.

Ryoki HaraDepartment of Pediatrics, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa, 236-0004, Japan. r.hara.ycuped@gmail.com.
Hiroaki UmebayashiDepartment of General Pediatrics, Miyagi Children's Hospital, 4-3-17 Ochiai, Aoba-ku, Sendai-shi, Miyagi, 989-3126, Japan.
Syuji TakeiDepartment of Pediatrics, Kagoshima University Medical and Dental Hospital, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8544, Japan.
Nami OkamotoDepartment of Pediatrics, Graduate School of Medicine, Osaka Medical College, 2-7 Daigaku-machi, Takatsuki-shi, Osaka, 569-8686, Japan.
Naomi IwataDepartment of Immunology and Infectious Diseases, Aichi Children's Health and Medical Center, 1-2 Osakata, Morioka-cho, Oobu-shi, Aichi, 474-8710, Japan.
Yuichi YamasakiDepartment of Pediatrics, Kagoshima University Medical and Dental Hospital, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8544, Japan.
Yasuo NakagishiDepartment of Pediatric Rheumatology, Hyogo Prefectural Kobe Children's Hospital, 1-6-7 Minamimachi, Minatojima, Chuo-ku, Kobe-shi, Hyogo, 650-0047, Japan.
Toshitaka KizawaDepartment of Pediatrics, Japan Community Health Care Organization Sapporo Hokushin Hospital, 1-2, 2-jo, 6-chrome, Atsubetsu-chuo, Atsubetsu-ku, Sapporo-shi, Hokkaido, 004-8618, Japan.
Ichiro KobayashiDepartment of Pediatrics, Hokkaido University Hospital, North-15, West-7, Sapporo-shi, Hokkaido, 060-8638, Japan.
Tomoyuki ImagawaDivision of Infection, Immunology and Rheumatology, Kanagawa Prefectural Hospital Organisation Kanagawa Children's Medical Center, 2-138-4 Mutsukawa, Minami-ku, Yokohama-shi, Kanagawa, 232-8555, Japan.
Noriko KinjoDepartment of Pediatrics, University of the Ryukyus Hospital, 207 Aza Uehara, Nishihara-cho, Nakagami-gun, Okinawa, 903-0215, Japan.
Norihito AmanoBristol-Myers Squibb K.K, 6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1328, Japan.
Yoko TakahashiBristol-Myers Squibb K.K, 6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1328, Japan.
Masaaki MoriDepartment of Lifetime Clinical Immunology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
Yasuhiko ItohDepartment of Pediatrics, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Shumpei YokotaFuji Toranomon Orthopaedics Hospital, 1067-1 Kawashimata, Gotenba-shi, Shizuoka, 412-0045, Japan.
Bristol-Myers Squibb (Japan) · JPKagoshima University · JPHokkaido University Hospital · JPKanagawa Children's Medical Center · JPKobe Children's Hospital · JPMiyagi Children's Hospital · JPNippon Medical School · JPOsaka Medical and Pharmaceutical University · JPTokyo Medical and Dental University · JPToranomon Hospital · JPUniversity of the Ryukyus · JPYokohama City University · JP

Funding

Ono Pharmaceutical Co., Ltd. NA
6 · The paper itself

Abstract

backgroundTo investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA).

methodsIn this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4-17 years who failed ≥1 biologic or methotrexate received weight-tiered (< 75 kg: 10 mg/kg; 75-100 kg: 750 mg; > 100 kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short-term period (16 weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions of patients achieving Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP) remission (score < 1) and minimal disease activity (MDA; score < 3.8), were among exploratory endpoints.

resultsAll 20 patients who received study medication completed the short-term period. During the long-term period, two patients discontinued due to insufficient efficacy or patient decision. Median age and disease duration at baseline were 10.5 and 0.75 years, respectively. Week 16 JIA-ACR30 response rate (primary endpoint) was 90.0% (18/20). JIA-ACR50/70/90 response and inactive disease rates at Week 16 were 75.0% (15/20), 70.0% (14/20), 35.0% (7/20), and 25.0% (5/20), respectively. At Week 52, JIA-ACR30/50/70/90 response and inactive disease rates were observed by 88.9% (16/18), 88.9% (16/18), 83.3% (15/18), 66.7% (12/18) and 44.4% (8/18), respectively. CHAQ-DI improved after Week 12. JADAS27-CRP remission and MDA were achieved by 15.0% (3/20) and 45.0% (9/20) of patients at Week 16, and by 50.0% (9/18) and 78.0% (14/18) of patients at Week 52, respectively. The mean abatacept pre-dose serum concentration was above the target therapeutic exposure (10 μg/ml) from Week 8 through Week 16. All adverse events were of mild/moderate intensity, except for one case of severe gastroenteritis. No deaths, malignancies, or autoimmune disorders were observed. No antidrug antibodies were detected through Week 16; one patient had a positive immunogenic response during the cumulative period.

conclusionIntravenous abatacept was efficacious and well tolerated in Japanese patients with active pJIA.

trial registrationClinicalTrials.gov: NCT01835470 . Date of registration: April 19, 2013.

Indexed as

AbataceptAdolescentAntirheumatic AgentsArthritis, JuvenileChildChild, PreschoolFemaleHumansInfusions, IntravenousMaleTime FactorsTreatment OutcomeAbataceptAntirheumatic AgentsAbataceptDisease-modifying anti-rheumatic drugs (DMARDs)JapaneseJuvenile idiopathic arthritisPharmacokinetics

Identifiers

PMID31039807
PMCPMC6492394
OpenAlexW2947182032

What OpenQuestion holds

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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.