Background: Primary immunodeficiency diseases (PID) are a group of rare disorders that patients do not have normal function of the immune system. Subcutaneous immunoglobulin 20% (SCIG-20%) was a candidate when considering replacement therapy with immunoglobulin in PID, but the evidence was not clear. To understand and interpret the available evidence, we conducted a systematic review to assess the efficacy and safety of SCIG-20% for patients with PID.
Method: Literature searches were conducted in PUBMED, EMBASE, Cochrane Library, CBM, VIP, CNKI, WanFang, LILACS and U.S. ClinicalTrials.gov. Clinical studies published in full text that met predefined inclusion criteria were eligible irrespective of language. Reviewers independently assessed all potential studies and extracted data. The fixed-effect model was used in meta-analysis.
Results: 4 studies involving 100 patients were included. The pooled rate of infection was 0.80 with the annual rate of 3.74. 38% patients missed days from work/school and annual rate was 4.54days in one year per patient. Only 4% patients were hospitalized due to infection and it costs 1.57days in one year per patient. 70% patients used antibiotics during 58.4days in one year per patient. 80 patients (80.0%) who experienced 1630 AEs were considered related to SCIG-20%. Only 7 related AEs were severe, of which, 4 were local reactions and 3 were headaches. Studies on health related quality of life and satisfaction suggested that patients with SCIG-20% had a good life quality and satisfied with SCIG treatment.
Conclusions: SCIG-20% treatment was not recommended for patients with primary immunodeficiency. Low quality of each outcome suggested that the evidence on effect of SCIG-20% for patients with PID is inadequate. Further comparative studies are urgently needed, especially in comparison with IVIG or SCIG of other concentrations.
Keywords: Primary immunodeficiency diseases; Subcutaneous immunoglobulin; Systematic review.
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