Journal Article: Intravenous immunoglobulin vs observation in childhood immune thrombocytopenia: a randomized controlled trial
The title of the article is Intravenous immunoglobulin vs observation in childhood immune thrombocytopenia: a randomized controlled trial.
The article was published in Blood in August 2018. The first author is Katja Heitink-Polle. The objective of this RTC is to address the question of whether IVIg treatment at the onset can prevent a chronic course of immune thrombocytopenia in children. The primary endpoint of the study was the development of chronic ITP, defined by platelet counts lower than 150 K/uL at 6 months after initial ITP. Children aged 3 months to 16 years with newly diagnosed IPT, a platelet count of 20 K/uL or less with mild to moderate bleeding meet inclusion criteria. The study enrolled a total of 200 patients. Patients were randomly assigned to IVIg or observation group, and followed up at 1 week, 1 month, 3 months, 6 months, and 12 months. The study found that chronic ITP occurred in 18.6% of patients in the IVIg group and 28.9% in the observation group. The complete response rate in the first 3 months is significantly higher in the IVIg group. The vast majority of children in the observation group did not have serious bleeding events. 100 patients would have to be treated with IVIg to prevent 8 severe bleeding events in the first month after diagnosis. The authors concluded that careful observation is safe in the vast majority of children with newly diagnosed ITP with bleeding grades below 4, and IVIg treatment should be tailored to children with a higher bleeding tendency.
