Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study

Clinical outcomes of women who become pregnant during/after facilitated subcutaneous immunoglobulin (fSCIG) treatment are not well characterized. This noninterventional, prospective, open-label, post authorization, pregnancy registry study assessed safety outcomes in mothers with primary immunodefic...

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Veröffentlicht in:	Immunotherapy 2022-06, Vol.14 (8), p.609-616
Hauptverfasser:	Borte, Michael, Raffac, Stefan, Hrubiško, Martin, Jahnz-Rozyk, Karina, Garcia, Enrique, McCoy, Barbara, Chavan, Shailesh, Nagy, Andras, Yel, Leman
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Sprache:	eng
Schlagworte:	facilitated subcutaneous immunoglobulin fSCIG IgRT immunoglobulin-replacement therapy infant PID pregnancy primary immunodeficiency diseases real-world data safety
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container_title	Immunotherapy
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creator	Borte, Michael Raffac, Stefan Hrubiško, Martin Jahnz-Rozyk, Karina Garcia, Enrique McCoy, Barbara Chavan, Shailesh Nagy, Andras Yel, Leman
description	Clinical outcomes of women who become pregnant during/after facilitated subcutaneous immunoglobulin (fSCIG) treatment are not well characterized. 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. 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. 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: ( ); EUPAS5798
doi_str_mv	10.2217/imt-2021-0336
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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. 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. Findings provide limited but useful safety data regarding women who received fSCIG before/during pregnancy and the growth/development of their infants. 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subjects	facilitated subcutaneous immunoglobulin fSCIG IgRT immunoglobulin-replacement therapy infant PID pregnancy primary immunodeficiency diseases real-world data safety
title	Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study
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