ArticleRheumatology (Oxford, England)2024
Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis.
Article in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02165345 (Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- The Asia-Pacific League of Associations for Rheumatology Consensus Recommendations on the Management of Systemic Juvenile Idiopathic Arthritis (Juvenile Still's Disease).International journal of rheumatic diseases · 2026Guideline
- Electroacupuncture for juvenile idiopathic arthritis: clinical efficacy and its role in modulating pyroptosis and autophagy pathways.Clinical rheumatology · 2025Trial
- Safety signals of tocilizumab in pediatric patients: A real-world pharmacovigilance analysis based on the FAERS database with network pharmacology insights.Human vaccines & immunotherapeutics · 2026Article
- Two- and 3-year outcomes of the childhood arthritis and rheumatology research alliance FiRst Line Options for sJIA Treatment (FROST) trial.Pediatric rheumatology online journal · 2026Article
- [Clinical characteristics and outcomes of children with rheu-matoid factor-positive polyarticular juvenile idiopathic arthritis].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2026Article
- Efficacy, safety, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab intravenously administered to adults with active rheumatoid arthritis and an inadequate response to methotrexate: a phase 3, randomised study.EULAR rheumatology open · 2026Article
- A nomogram based on LASSO-logistic regression for predicting tocilizumab-associated hypofibrinogenemia in patients with rheumatic diseases.Frontiers in pharmacology · 2026Article
- Interleukin-6 in complications of prematurity: from biomarker to targeted therapy.Frontiers in pediatrics · 2026Review
- The evolving landscape of rheumatic drugs and their indications in paediatric and adolescent care.Rheumatology (Oxford, England) · 2025Review
- Pharmacovigilance analysis of drug-induced hypofibrinogenemia using the FDA Adverse Event Reporting System.International journal of clinical pharmacy · 2025Article
- 25 Years of Biologics for the Treatment of Pediatric Rheumatic Disease: Advances in Prognosis and Ongoing Challenges.Arthritis care & research · 2025Review
- Characteristics, risk factors and a risk prediction model of tocilizumab-induced hypofibrinogenemia: a retrospective real-world study of inpatients.BMC pharmacology & toxicology · 2025Article
- Interleukin family in vascular calcification: molecular mechanisms and therapeutic perspectives.Frontiers in cardiovascular medicine · 2025Review
- Update on Biologic Therapy in Juvenile Idiopathic Arthritis: A Five-year Narrative Review.Biologics : targets & therapy · 2025Review
- Advancing multidisciplinary management of pediatric hyperinflammatory disorders.Frontiers in pediatrics · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 18 institutions in 10 countries.
Funding
Abstract
objectiveTo investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA or sJIA).
methodsPatients with pJIA or sJIA from two open-label, 52-week phase 1b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight-based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years, and safety for up to 5 years in the LTE.
resultsForty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values: pJIA, ∼10 μg/ml; sJIA, ∼75 μg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection).
conclusionPatients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile. CLINICAL
trial registrationclinicaltrials.gov, NCT02165345.
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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.