Open AccessLong-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study
Author(s) -
Michael Borte,
Štefan Raffáč,
M Hrubiško,
Karina JahnzRóżyk,
Enrique Rivera García,
Barbara McCoy,
Shailesh Chavan,
András Nagy,
Leman Yel
Publication year - 2022
Publication title -
immunotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.127
H-Index - 48
eISSN - 1750-7448
pISSN - 1750-743X
DOI - 10.2217/imt-2021-0336
Subject(s) - medicine , pregnancy , adverse effect , pediatrics , clinical trial , authorization , primary immunodeficiency , gestation , obstetrics , disease , genetics , computer security , computer science , biology
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