IVMP1IVIG raises platelet counts faster than IVIG alone: Results of a randomized, blinded trial in childhood ITP

Manuel Carcao; Mariana Silva; Michele David; Robert J. Klaassen; MacGregor Steele; Victoria Price; Cindy Wakefield; Lussia Kim; Derek Stephens; Victor S. Blanchette

doi:10.1182/bloodadvances.2019001343

IVMP1IVIG raises platelet counts faster than IVIG alone: Results of a randomized, blinded trial in childhood ITP

Manuel Carcao, Mariana Silva, Michele David, Robert J. Klaassen, MacGregor Steele, Victoria Price, Cindy Wakefield, Lussia Kim, Derek Stephens, Victor S. Blanchette

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

Abstract

Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs ,20 3 10⁹/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 3 10⁹/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC $20 3 10⁹/L (no group difference). By 24 hours, mean PCs were 76.9 3 10⁹/L (B) vs 55 3 10⁹/L (A) (P 5 .06; P 5 .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P 5 .046). Our ﬁndings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP1IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.

Original language	English
Pages (from-to)	1492-1500
Number of pages	9
Journal	Blood advances
Volume	4
Issue number	7
DOIs	https://doi.org/10.1182/bloodadvances.2019001343
Publication status	Published - Apr 14 2020
Externally published	Yes

Bibliographical note

Funding Information:
The authors thank the patients/families, nurses, and clinical research associates in our centers who participated in the study (Hospital for Sick Children, Toronto, ON, Canada; Children's Hospital of Eastern Ottawa, Ottawa, ON, Canada; Kingston General Hospital, Kingston, ON, Canada; Ste-Justine Hôpital, Montreal, QC, Canada; IWK Health Centre, Halifax, NS, Canada; and Alberta Children's Hospital, Calgary, AB, Canada). The authors also thank the members of the Data Monitoring Safety Board (Kaiser Ali, Sara Israels, and Shinya Ito). Funding for this study was provided through an investigator-initiated peer-reviewed grant submitted to the Bayer-Talecris-Canadian Blood Services Partnership fund.

Publisher Copyright:
© 2020 by The American Society of Hematology

ASJC Scopus Subject Areas

Hematology

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10.1182/bloodadvances.2019001343

Cite this

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title = "IVMP1IVIG raises platelet counts faster than IVIG alone: Results of a randomized, blinded trial in childhood ITP",

abstract = "Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs ,20 3 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 3 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC $20 3 109/L (no group difference). By 24 hours, mean PCs were 76.9 3 109/L (B) vs 55 3 109/L (A) (P 5 .06; P 5 .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P 5 .046). Our ﬁndings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP1IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.",

author = "Manuel Carcao and Mariana Silva and Michele David and Klaassen, {Robert J.} and MacGregor Steele and Victoria Price and Cindy Wakefield and Lussia Kim and Derek Stephens and Blanchette, {Victor S.}",

note = "Funding Information: The authors thank the patients/families, nurses, and clinical research associates in our centers who participated in the study (Hospital for Sick Children, Toronto, ON, Canada; Children's Hospital of Eastern Ottawa, Ottawa, ON, Canada; Kingston General Hospital, Kingston, ON, Canada; Ste-Justine H{\^o}pital, Montreal, QC, Canada; IWK Health Centre, Halifax, NS, Canada; and Alberta Children's Hospital, Calgary, AB, Canada). The authors also thank the members of the Data Monitoring Safety Board (Kaiser Ali, Sara Israels, and Shinya Ito). Funding for this study was provided through an investigator-initiated peer-reviewed grant submitted to the Bayer-Talecris-Canadian Blood Services Partnership fund. Publisher Copyright: {\textcopyright} 2020 by The American Society of Hematology",

year = "2020",

month = apr,

day = "14",

doi = "10.1182/bloodadvances.2019001343",

language = "English",

volume = "4",

pages = "1492--1500",

journal = "Blood advances",

issn = "2473-9529",

publisher = "Elsevier BV",

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T1 - IVMP1IVIG raises platelet counts faster than IVIG alone

T2 - Results of a randomized, blinded trial in childhood ITP

AU - Carcao, Manuel

AU - Silva, Mariana

AU - David, Michele

AU - Klaassen, Robert J.

AU - Steele, MacGregor

AU - Price, Victoria

AU - Wakefield, Cindy

AU - Kim, Lussia

AU - Stephens, Derek

AU - Blanchette, Victor S.

N1 - Funding Information: The authors thank the patients/families, nurses, and clinical research associates in our centers who participated in the study (Hospital for Sick Children, Toronto, ON, Canada; Children's Hospital of Eastern Ottawa, Ottawa, ON, Canada; Kingston General Hospital, Kingston, ON, Canada; Ste-Justine Hôpital, Montreal, QC, Canada; IWK Health Centre, Halifax, NS, Canada; and Alberta Children's Hospital, Calgary, AB, Canada). The authors also thank the members of the Data Monitoring Safety Board (Kaiser Ali, Sara Israels, and Shinya Ito). Funding for this study was provided through an investigator-initiated peer-reviewed grant submitted to the Bayer-Talecris-Canadian Blood Services Partnership fund. Publisher Copyright: © 2020 by The American Society of Hematology

PY - 2020/4/14

Y1 - 2020/4/14

N2 - Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs ,20 3 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 3 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC $20 3 109/L (no group difference). By 24 hours, mean PCs were 76.9 3 109/L (B) vs 55 3 109/L (A) (P 5 .06; P 5 .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P 5 .046). Our ﬁndings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP1IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.

AB - Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs ,20 3 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 3 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC $20 3 109/L (no group difference). By 24 hours, mean PCs were 76.9 3 109/L (B) vs 55 3 109/L (A) (P 5 .06; P 5 .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P 5 .046). Our ﬁndings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP1IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.

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IVMP1IVIG raises platelet counts faster than IVIG alone: Results of a randomized, blinded trial in childhood ITP

Abstract

Bibliographical note

ASJC Scopus Subject Areas

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