Study Aims to Determine Feasibility of Low-Dose Intravenous Immunoglobulin in Children With Immune Thrombocytopenia

A new study seeks to determine whether a low dose of intravenous immunoglobulin (IVIG) in children with newly diagnosed immune thrombocytopenia (ITP) can effectively stop bleeding and result in a durable response while lowering the financial burden incurred with higher doses, according to a protocol published in BMJ Open.

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Typical first-line therapy for children with ITP consists of corticosteroids, IVIG or a combination of both for certain patients. Multiple studies have shown that IVIG can increase platelet counts more quickly than corticosteroids and can reduce the risk of chronic ITP, the study authors wrote.

However, the costs are IVIG are high, with a reported median medical cost of $6275, which can be even more pronounced for children who require high doses of IVIG. Further, high doses of IVIG were reported to be one of the main risk factors for IVIG-related adverse effects (AEs), such as thrombotic events and aseptic meningitis, the investigators explained.

The researchers will include randomized-control trials (RCT), quasi-randomized RCTs, and prospective observational studies that compare different doses of IVIG for children with ITP in their review. Patients included will be pediatric (18 years old or less) with newly diagnosed ITP, the researchers say.

Interventions that will be included in the investigators’ meta-analysis will be all studies involving the administration of IVIG that compare different doses. The primary outcome of the studies selected will be the proportion of patients achieving a durable response, while the secondary outcomes include the proportion of patients achieving an initial response and AEs.

Investigators plan to utilize an extensive search strategy to locate any available articles and will search a variety of databases. To select the studies for the review, 2 reviewers will independently conduct screening and selection, with any disagreement being resolved by a third reviewer.

Regarding data management, 2 reviewers will independently extract necessary data from each eligible study using a prespecified data extraction form and then cross-checking the results, the researchers explain.

The investigators will extract sample size, participant baseline characteristics, details of experimental and comparator interventions, outcomes, follow-up period, and AEs, along with other general information, such as author name and year of publication.

To measure the estimated effect of dichotomous variables, the researchers will use a risk ratio with 95% confidence interval (CI). For any continuous variables, the estimated effect will be measured using mean difference with 95% CI.

The researchers will perform a subgroup analysis based on the different total doses of IVIG. Subgroups will be divided into a group who received high-dose IVIG (total dose of 2 g/kg body weight) and a group who received moderate-dose IVIG (total dose of 1-2 g/kg body weight). If there are sufficient data regarding corticosteroids, then the investigators will conduct further analysis on those factors.

The GRADE system will be used to evaluate the reliability and certainty of the evidence, which is based on 5 aspects: the risk of bias, inconsistency, indirectness, imprecision, and publication bias, according to the study authors. Based on this system, their certainty of the evidence will be categorized as high, moderate, low, or very low.

“The findings from this study may help healthcare providers and policymakers to select an appropriate dosage regimen which may ultimately lead to a reduction in medical costs,” the researchers concluded.

Reference

Ren X, Zhang M, Zhang X, Zhao P, Zhai W. Low-dose intravenous immunoglobulin for children with newly diagnosed immune thrombocytopenia: protocol of a systematic review and meta-analysis. BMJ Open. 2023;13(6):e071644. doi:10.1136/bmjopen-2023-071644