The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease

KIDCARE Multicenter Study Group

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10–20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. Objectives: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. Methods: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5–18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. Conclusion: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.

Original languageEnglish (US)
Pages (from-to)98-103
Number of pages6
JournalContemporary Clinical Trials
Volume79
DOIs
StatePublished - Apr 2019

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Mucocutaneous Lymph Node Syndrome
Intravenous Immunoglobulins
Therapeutics
Fever
Coronary Vessels
Hospitalization
Infliximab
Coronary Aneurysm
Intravenous Infusions
Signs and Symptoms
Heart Diseases
Outpatients
Randomized Controlled Trials

Keywords

  • IVIG
  • IVIG-resistance
  • Infliximab
  • Kawasaki disease

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{e1e62d55594542179585f83740a406a0,
title = "The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease",
abstract = "Background: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10–20{\%} of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. Objectives: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. Methods: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5–18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. Conclusion: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.",
keywords = "IVIG, IVIG-resistance, Infliximab, Kawasaki disease",
author = "{KIDCARE Multicenter Study Group} and Roberts, {Samantha C.} and Sonia Jain and Tremoulet, {Adriana H.} and Kim, {Katherine K.} and Burns, {Jane C.} and Vikram Anand and Marsha Anderson and Jocelyn Ang and Emily Ansusinha and Moshe Arditi and Negar Ashouri and Allison Bartlett and Archana Chatterjee and Roberta DeBiasi and Cornelia Dekker and Chandani DeZure and Lisa Didion and Samuel Dominguez and {El Feghaly}, Rana and Guliz Erdem and Natasha Halasa and Ashraf Harahsheh and Jackson, {Mary Anne} and Preeti Jaggi and Supriya Jain and Jone, {Pei Ni} and Neeru Kaushik and Gregory Kurio and Anna Lillian and David Lloyd and John Manaloor and Amy McNelis and Michalik, {David E.} and Jane Newburger and Charles Newcomer and Tiffany Perkins and Michael Portman and Jose Romero and Tova Ronis and Anne Rowley and Kathryn Schneider and Jennifer Schuster and Tejtel, {S. Kristen Sexson} and Kavita Sharma and Kari Simonsen and Jacqueline Szmuszkovicz and Dongngan Truong and James Wood and Sylvia Yeh",
year = "2019",
month = "4",
doi = "10.1016/j.cct.2019.02.008",
language = "English (US)",
volume = "79",
pages = "98--103",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial

T2 - A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease

AU - KIDCARE Multicenter Study Group

AU - Roberts, Samantha C.

AU - Jain, Sonia

AU - Tremoulet, Adriana H.

AU - Kim, Katherine K.

AU - Burns, Jane C.

AU - Anand, Vikram

AU - Anderson, Marsha

AU - Ang, Jocelyn

AU - Ansusinha, Emily

AU - Arditi, Moshe

AU - Ashouri, Negar

AU - Bartlett, Allison

AU - Chatterjee, Archana

AU - DeBiasi, Roberta

AU - Dekker, Cornelia

AU - DeZure, Chandani

AU - Didion, Lisa

AU - Dominguez, Samuel

AU - El Feghaly, Rana

AU - Erdem, Guliz

AU - Halasa, Natasha

AU - Harahsheh, Ashraf

AU - Jackson, Mary Anne

AU - Jaggi, Preeti

AU - Jain, Supriya

AU - Jone, Pei Ni

AU - Kaushik, Neeru

AU - Kurio, Gregory

AU - Lillian, Anna

AU - Lloyd, David

AU - Manaloor, John

AU - McNelis, Amy

AU - Michalik, David E.

AU - Newburger, Jane

AU - Newcomer, Charles

AU - Perkins, Tiffany

AU - Portman, Michael

AU - Romero, Jose

AU - Ronis, Tova

AU - Rowley, Anne

AU - Schneider, Kathryn

AU - Schuster, Jennifer

AU - Tejtel, S. Kristen Sexson

AU - Sharma, Kavita

AU - Simonsen, Kari

AU - Szmuszkovicz, Jacqueline

AU - Truong, Dongngan

AU - Wood, James

AU - Yeh, Sylvia

PY - 2019/4

Y1 - 2019/4

N2 - Background: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10–20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. Objectives: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. Methods: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5–18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. Conclusion: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.

AB - Background: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10–20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. Objectives: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. Methods: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5–18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. Conclusion: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.

KW - IVIG

KW - IVIG-resistance

KW - Infliximab

KW - Kawasaki disease

UR - http://www.scopus.com/inward/record.url?scp=85062835937&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85062835937&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2019.02.008

DO - 10.1016/j.cct.2019.02.008

M3 - Article

C2 - 30840903

AN - SCOPUS:85062835937

VL - 79

SP - 98

EP - 103

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

ER -