A comparison of intravenous immunoglobulin (2 g/kg totally) and single doses of anti-D immunoglobulin at 50 μg/kg, 75 μg/kg in newly diagnosed children with idiopathic thrombocytopenic purpura

Abstract

We conducted this prospective randomized trial of intravenous immunoglobulin (IVIG) treatment in children with newly diagnosed immune thrombocytopenic purpura (ITP) to compare the efficacy of IVIG to standard and higher doses of anti-D IVIG. Seventy-eight patients who were previously untreated and between the age of 1 and 18 years with newly diagnosed acute ITP and a platelet concentration less than 20×10/l were eligible for enrollment. In this study IVIG treatment was compared with two different doses of anti-D. Study patients were randomized to receive treatment according to one of the two single anti-D IVIG doses [50 μg/kg (n=19) or 75 μg/kg (n=20)] or 2 g/kg (400 mg/kg per day, 5 day) total dose of IVIG (n=39). There is a significant increase of 24th hour, 48th hour, 72nd hour, 7th day and 30th day platelet counts in IVIG (2 g/kg, total dose) group compared to anti-D IVIG 50 μg/kg and anti-D IVIG 75 μg/kg groups. However, there were no difference between 24th hour, 48th hour, 72nd hour, 7th day and 30th day platelet counts across anti-D IVIG 50 μg/kg and anti-D IVIG 75 μg/kg groups. In conclusion, this study suggests that IVIG is well tolerated and significantly more effective than standard and high-dose anti-D IVIG for the treatment of newly diagnosed ITP in children. Apart from this, we believe that IVIG might be the first-line treatment of these patients. Regarding this issue further prospective studies comparing different IVIG treatment regimens with anti-D IVIG treatment regimens are needed.

Updated international consensus report on the investigation and management of primary immune thrombocytopenia

“…The most common treatment schedule for IVIg in children with newly diagnosed ITP is 0.8 to 1 g/kg in a single dose, 79,84,256,[258][259][260] but some studies continue to use 0.4 g/kg per day over 5 days. 244,261 It is often combined with steroids, antihistamines, and paracetamol to reduce side effects, especially headaches. Treatment is usually discontinued once a safe platelet count is reached, although it can be repeated as/if needed.…”

“…79,256,260 Common AEs include headache, nausea/vomiting, and fever/chills. 79,256,[259][260][261] As described above, 4 studies have compared IVIg with anti-D in children newly diagnosed with ITP; 3 studies reported no significant difference, and 1 study reported improved efficacy with IVIg (evidence level Ib-IIb). 244,258,259,261 The phase 3 TIKI trial compared single-dose IVIg (0.8 g/kg) with observation in children with newly diagnosed ITP, platelet count #20 3 10 9 /L, and grade 1-3 bleeding (evidence level Ib).…”

“…79,256,[259][260][261] As described above, 4 studies have compared IVIg with anti-D in children newly diagnosed with ITP; 3 studies reported no significant difference, and 1 study reported improved efficacy with IVIg (evidence level Ib-IIb). 244,258,259,261 The phase 3 TIKI trial compared single-dose IVIg (0.8 g/kg) with observation in children with newly diagnosed ITP, platelet count #20 3 10 9 /L, and grade 1-3 bleeding (evidence level Ib). 256 Overall and complete response rates were significantly higher with IVIg vs observation at 1 week and 1 month, at 3 months only the complete response rate was significantly higher, and at 6 and 12 months there was no significant difference in either measure.…”

“…IV ANTI-D. IV anti-D can be given to Rh(D)-positive children as a short infusion, and it is usually effective in transiently increasing platelet counts. 90,244,258,259,261,262 Four studies since 2010 have evaluated the treatment efficacy of anti-D in newly diagnosed children with ITP and compared with IVIg, methylpredniso(lo)ne, or both. 244,258,259,261 Three studies reported no significant difference between single-dose anti-D (50 or 75 mg/kg) and IVIg (single-dose 0.8-1 g/kg or 5 3 0.4 g/kg per day) in children newly diagnosed with ITP (evidence level Ib-IIb); 1 study also reported no difference compared with methylpredniso(lo)ne (2 mg/kg per day) (evidence level Ib).…”

Comparison of the Therapeutic Effect of Anti-D IG and IVIG in Children with Acute Immune Thrombocytopenic Purpura Attending a Children’s Medical Center: A Randomized, Double-Blind, Controlled Clinical Trial

“…However, these studies are mostly retrospective and have different methodological errors. On the other hand, there are a few clinical trials, whose results are inconsistent due to small sample size and other errors (22)(23)(24)(25)(26)(27)(28).…”