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

Authors: Borte, M; Raffac, S; Hrubiško, M; Jahnz-Rozyk, K; Garcia, E; McCoy, B; Chavan, S; Nagy, A; Yel, L

Affiliations: Klinik für Kinder- und Jugendmedizin, Klinikum St Georg GmbH, Leipzig, Germany. Clinic of Clinical Immunology and Allergology, RAFMED s.r.o, Košice, Slovak Republic. Department of Clinical Allergology and Immunology, Oncology Institute of St. Elisabeth, Bratislava, Slovak Republic. Department of Internal Medicine, Pneumology, Allergology and Clinical Immunology, Military Institute of Medicine, Warsaw, Poland. Plasma-Derived Therapies BU, Baxalta Innovations GmbH, a Takeda company, Vienna, Austria. Plasma-Derived Therapies BU, Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA.

Publication: Immunotherapy ; 2022

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.