Evidence map›Paper›PMID 39279018›Full record

Trial reportClinical rheumatology2024

Efficacy and safety of tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis: a multicentre phase IV trial.

Caifeng Li, Xuemei Tang, Zhixuan Zhou, Li Sun, Meiping Lu, Wei Zhou, Sirui Yang, Wenjie Zheng, Haiguo Yu, Weiping Tan and 4 more

Abstract readMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical rheumatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
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

14 authors.

Caifeng LiDepartment of Rheumatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, No. 56 South Lishi Road, Xicheng District, Beijing, 100045, China. caifeng_li@yeah.net.ORCID http://orcid.org/0009-0002-8217-6765
Xuemei TangDepartment of Rheumatology and Immunology, Children's Hospital of Chongqing Medical University, Chongqing, China.
Zhixuan ZhouDepartment of Rheumatology and Immunology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.
Li SunDepartment of Rheumatology, Children's Hospital of Fudan University, Shanghai, China.
Meiping LuDepartment of Rheumatology, Immunology and Allergy, Children's Hospital Affiliated to Zhejiang University School of Medicine, Zhejiang, China.
Wei ZhouDepartment of Nephrology, Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Sirui YangDepartment of Pediatric Rheumatology and Allergy, The First Hospital of Jilin University, Jilin, China.
Wenjie ZhengDepartment of Pediatric Rheumatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Zhejiang, China.
Haiguo YuDepartment of Rheumatology and Immunology, Children's Hospital of Nanjing Medical University, Jiangsu, China.
Weiping TanDepartment of Pediatrics, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangdong, China.
Junmei ZhangDepartment of Rheumatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, No. 56 South Lishi Road, Xicheng District, Beijing, 100045, China.
Yu ZhangDepartment of Rheumatology and Immunology, Children's Hospital of Chongqing Medical University, Chongqing, China.
Yuxiu KongMedical Affairs, Shanghai Roche Pharmaceuticals Co., Ltd., Shanghai, China.
Jiahui XuMedical Affairs, Shanghai Roche Pharmaceuticals Co., Ltd., Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesGiven the limited tocilizumab (TCZ) treatment data for systemic juvenile idiopathic arthritis (sJIA) in China, we evaluated the long-term efficacy and safety of TCZ in Chinese patients with sJIA.

methodIn this multicentre, interventional Phase IV study, patients with sJIA and inadequate clinical response to non-steroidal anti-inflammatory drugs/corticosteroids received TCZ infusions every 2 weeks based on body weight (< 30 kg, 12 mg/kg; ≥ 30 kg, 8 mg/kg), over a 52-week open-label period and an 8-week safety follow-up period. The primary endpoint was the proportion of patients with a JIA American College of Rheumatology (ACR) 30 response and absence of fever at Week 12.

resultsSixty-two patients were enrolled and treated (12-mg/kg group, 34; 8-mg/kg group, 28). At Week 12, 87.1% (95% confidence interval 78.8%-95.4%) of patients had JIA ACR 30 response and absence of fever; Week 52 results were similar. The proportion of JIA ACR 30/50/70/90 responders rapidly increased at Week 12, up to Week 52. High-sensitivity C-reactive protein (hsCRP) levels decreased within 4 weeks; 44/58 patients (75.9%) with elevated baseline hsCRP recovered at Week 52. Childhood Health Assessment Questionnaire pain scores, disability index scores, and mean corticosteroid dose decreased over time. Height standard deviation score changes at Week 52 indicated catch-up growth. Most adverse events (AEs) were mild (serious AE incidence, 17.7%). No deaths or macrophage activation syndrome occurred.

conclusionThis is the first multicentre trial to report the efficacy and safety of TCZ in Chinese patients with sJIA at 52 weeks. No new safety concerns were found.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, JuvenileAdolescentChildChild, PreschoolChinaEast Asian PeopleFemaleHumansMaleTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentstocilizumabBiological therapySystemic juvenile idiopathic arthritisTocilizumab

Identifiers

PMID39279018
PMCPMC11489204

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.