Long-Term Safety of Facilitated Subcutaneous Immunoglobulin Treatment in Pregnant Women with Primary Immunodeficiency Diseases: Results from a Registry Study
Year: 2022
Type: article
Study design: Observational Study
Abstract: Aim: Clinical outcomes of women who become pregnant during/after facilitated subcutaneous immunoglobulin (fSCIG) treatment are not well characterized. Materials & methods: This noninterventional, prospective, open-label, post authorization, pregnancy registry study assessed safety outcomes in mothers with primary immunodeficiency diseases who had ever received fSCIG before/during pregnancy and their infants (n = 7). Enrolled women received alternative treatment (arm 1: n = 2) or continued fSCIG (arm 2: n = 7) during pregnancy. Results: No treatment-related adverse events (AEs)/serious AEs (SAEs) were reported. 13 AEs occurred in mothers, including two SAEs (thrombocytopenia, pre-eclampsia; arm 2). A total of 17 AEs occurred in infants, including two SAEs (cleft lip, talipes calcaneovalgus; arm 2) with normal growth/development. Conclusion: Findings provide limited but useful safety data regarding women who received fSCIG before/during pregnancy and the growth/development of their infants.Clinical Trial registration: NCT02556775 (ClinicalTrials.gov); EUPAS5798
Source: Immunotherapy
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4224236087