Trial reportScientific reports2018
Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial.
Trial report in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01596335 (To Evaluate the Efficacy and Safety of TA-650 in Comparison With a Control Drug Polyethylene Glycol-treated Human Immunoglobulin), which is not on this map. Cited by 37 papers, 7 of them syntheses that pooled 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.
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.
To Evaluate the Efficacy and Safety of TA-650 in Comparison With a Control Drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in Patients With Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin (IVIG).
Who cites it
37 citing papers in PubMed, 7 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Anakinra for intravenous immunoglobulin-resistant Kawasaki disease: a systematic literature review.RMD open · 2026Pooled it
- Assessing the efficacy of infliximab in promoting vascular and mucosal healing in immunoglobulin-resistant kawasaki disease: a meta-analysis.BMC pediatrics · 2025Pooled it
- Intravenous immunoglobulin for the treatment of Kawasaki disease.The Cochrane database of systematic reviews · 2023Pooled it
- Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trials.Pediatric rheumatology online journal · 2021Pooled it
- Pooled it
- TNF-α blockers for the treatment of Kawasaki disease in children.The Cochrane database of systematic reviews · 2019Pooled it
- Indirect-comparison meta-analysis of treatment options for patients with refractory Kawasaki disease.BMC pediatrics · 2019Pooled it
- Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease.Pediatrics international : official journal of the Japan Pediatric Society · 2021Trial
- Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet's disease: a large-scale, long-term postmarketing surveillance in Japan.Arthritis research & therapy · 2019Trial
- Infliximab as an Effective Second-Line Treatment for IVIG-Resistant Kawasaki Disease Accompanied by Severe Dyslipidemia.Pediatric cardiology · 2026Article
- Predicting the Need for Infliximab in Kawasaki Disease Using N-Terminal Pro-Brain Natriuretic Peptide at Diagnosis.Pediatric cardiology · 2026Article
- Ruxolitinib combined with corticosteroids for the successful treatment of kawasaki disease-associated macrophage activation syndrome: a case report.Frontiers in pediatrics · 2026Article
- Favorable coronary outcomes following IL-6 blockade with tocilizumab in IVIG-resistant kawasaki disease: a case series.Frontiers in immunology · 2026Article
- Refractory Kawasaki Disease in Infants Complicated with Giant Coronary Artery Aneurysms and Takayasu Arteritis: A Rare Case Report and Literature Review.Vascular health and risk management · 2026Review
- Cost-effectiveness analysis of second intravenous immunoglobulin infusion versus infliximab for treating IVIG-resistant Kawasaki disease patients.Cost effectiveness and resource allocation : C/E · 2025Article
- Progress on diagnosis and treatment of multisystem inflammatory syndrome in children.Frontiers in immunology · 2025Review
- Treatment of multisystem inflammatory syndrome in children.World journal of pediatrics : WJP · 2024Review
- COVID-19-Related Multi-systemic Inflammatory Syndrome in Children (MIS-C).Advances in experimental medicine and biology · 2024Review
- Research perspective in the clinical management of Kawasaki disease.Frontiers in pediatrics · 2024Review
- Infliximab for intensification of primary therapy for patients with Kawasaki disease and coronary artery aneurysms at diagnosis.Archives of disease in childhood · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 14 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We compared the efficacy and safety of infliximab with intravenous immunoglobulin (IVIG), a standard therapy, in a phase 3 trial (NCT01596335) for Japanese patients with Kawasaki disease (KD) showing persistent fever after initial IVIG. Patients with initial IVIG-refractory KD, aged 1-10 years, received a single dose of IV infliximab 5 mg/kg or IV polyethylene glycol-treated human immunoglobulin (VGIH) 2 g/kg on day 0. Primary outcome was defervescence rate within 48 h after the start of treatment. Safety was evaluated through day 56. Overall, 31 patients were randomized (infliximab, n = 16; VGIH, n = 15); 31.3% and 60.0% patients discontinued due to worsening KD. Defervescence rate within 48 h was greater with infliximab (76.7%) than VGIH (37.0%) (p = 0.023), and defervescence was achieved earlier with infliximab (p = 0.0072). Coronary artery lesions occurred in 1 (6.3%) and 3 (20.0%) patients receiving infliximab and VGIH, respectively, up to day 21. Adverse events occurred in 15 (93.8%) and 15 (100.0%) patients in the infliximab and VGIH groups, respectively. No serious adverse events in the infliximab group and one in the VGIH group were observed. Infliximab improved the defervescence rate within 48 h and time to defervescence versus standard therapy, and was well tolerated in patients with IVIG-refractory KD.
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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.