Effectiveness and Safety of Initiating Treatment for Primary Immunodeficiency with Subcutaneously Administered Immunoglobulins – A Systematic Review of the Literature
The aim of the systematic review of the literature published last year was to evaluate the effectiveness and safety of initiating treatment with subcutaneously administered immunoglobulins (SCIG) in patients with primary immunodeficiency (PID) who had not previously been treated with this modality. There was insufficient data available for such a defined population because SCIGs had typically been introduced into studies only after intravenously administered immunoglobulins (IVIG).
Purpose and Objectives of the Systematic Review
Immunoglobulin substitution is the cornerstone of treatment for patients with significantly impaired antibody production, with the aim of preventing infections. The standard for initiating and long-term administration of treatment is the intravenous application of immunoglobulins. Subcutaneous administration of immunoglobulins has also become an established option, offering patients previously treated with IVIG various application possibilities that they can adapt to their needs.
In common practice, the treatment of primary immunodeficiency (PID) is initiated with IVIG or directly with SCIG. The evaluation of the effectiveness of SCIG as the first method of immunoglobulin substitution has been sporadic. The authors of the cited work below attempted to summarize existing knowledge, with the aim of evaluating the effectiveness and safety of this therapy and the quality of life of patients with PID without prior immunoglobulin substitution, who were initiated on SCIG.
Included Studies
A literature survey without language restrictions was conducted in the MEDLINE, Embase, BioSciences Information Service, and Cochrane Library databases as of publication date March 30, 2021. Sixteen studies met the inclusion criteria. None of these had a randomized controlled design; 14 were retrospective, and 1 was cross-sectional. Five studies included only patients without previous immunoglobulin administration. The population size in these studies ranged from 14 to 15,327 patients. Assessing the quality of the works was more difficult.
Findings
Treatment with SCIG in patients with PID without prior immunoglobulin substitution led to increased levels of immunoglobulin G (IgG) and a reduction in the burden of infections due to PID. Similar pharmacokinetic parameters and responses to treatment were achieved in both immunoglobulin-pretreated and non-pretreated patients after the completion of the loading dose phase.
The most commonly reported adverse events overall were erythema, swelling, or pain and discomfort at the infusion site, generally of mild nature.
Three studies showed significant improvements in health-related quality of life following SCIG initiation.
Conclusion and Discussion
Based on data from available studies, similar tolerance profiles, target immunoglobulin levels, and improvements in health-related quality of life are achieved with SCIG initiation in patients with PID who had not previously undergone immunoglobulin substitution as with SCIG initiation in patients previously treated with IVIG. The authors propose conducting new studies to evaluate optimal loading dose regimens of SCIG in patients without prior immunoglobulin substitution and to directly compare clinical outcomes and quality of life developments with SCIG administration in immunoglobulin-pretreated and non-pretreated patients.
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Source: Anderson-Smits C., Park M., Bell J. et al. Subcutaneous immunoglobulin use in immunoglobulin-naive patients with primary immunodeficiency: a systematic review. Immunotherapy 2022 Apr; 14 (5): 373−387, doi: 10.2217/imt-2021-0265.
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