IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, blinded trial in childhood ITP

Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada. Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada. Kingston General Hospital, Kingston, ON, Canada. Pediatric Hematology Oncology, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada. Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada. Alberta Children's Hospital, Calgary, AB, Canada. Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada; and. Department of Nursing, Hospital for Sick Children, Toronto, ON, Canada.

Blood Adv. 2020;4(7):1492-1500
PICO Summary

Population

Children with immune thrombocytopenia (ITP), (n=32).

Intervention

IV methylprednisolone (IVMP 30 mg/kg) followed by IVIG (Gamunex 10%) 1 g/kg, (n=14).

Comparison

IV placebo followed by IVIG (Gamunex 10%) 1 g/kg, (n=18).

Outcome

By 8 hours after initiating therapy, 55% of all children had a platelet count (PC) >/=20 x 109/L (no group difference). By 24 hours, mean PCs were 76.9 x 109/L (B) vs 55 x 109/L (A). No patient experienced severe bleeding/unexpected severe associated adverse events. There were statistically fewer IVIG-related headaches in the group receiving combination therapy.
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 x 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 x 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 x 109/L (no group difference). By 24 hours, mean PCs were 76.9 x 109/L (B) vs 55 x 109/L (A) (P = .06; P = .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 = .046). Our findings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP+IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine