PMID- 35443783
OWN - NLM
STAT- MEDLINE
DCOM- 20220512
LR  - 20220613
IS  - 1750-7448 (Electronic)
IS  - 1750-743X (Linking)
VI  - 14
IP  - 8
DP  - 2022 Jun
TI  - Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant 
      women with primary immunodeficiency diseases: results from a registry study.
PG  - 609-616
LID - 10.2217/imt-2021-0336 [doi]
AB  - 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.
FAU - Borte, Michael
AU  - Borte M
AD  - Klinik fur Kinder- und Jugendmedizin, Klinikum St Georg GmbH, Leipzig, Germany.
FAU - Raffac, Stefan
AU  - Raffac S
AD  - Clinic of Clinical Immunology and Allergology, RAFMED s.r.o, Kosice, Slovak 
      Republic.
FAU - Hrubisko, Martin
AU  - Hrubisko M
AUID- ORCID: 0000-0002-3954-7172
AD  - Department of Clinical Allergology and Immunology, Oncology Institute of St. 
      Elisabeth, Bratislava, Slovak Republic.
FAU - Jahnz-Rozyk, Karina
AU  - Jahnz-Rozyk K
AUID- ORCID: 0000-0002-3505-1858
AD  - Department of Internal Medicine, Pneumology, Allergology and Clinical Immunology, 
      Military Institute of Medicine, Warsaw, Poland.
FAU - Garcia, Enrique
AU  - Garcia E
AD  - Plasma-Derived Therapies BU, Takeda Development Center Americas, Inc., Cambridge, 
      MA 02142, USA.
FAU - McCoy, Barbara
AU  - McCoy B
AD  - Plasma-Derived Therapies BU, Baxalta Innovations GmbH, a Takeda company, Vienna, 
      Austria.
FAU - Chavan, Shailesh
AU  - Chavan S
AD  - Plasma-Derived Therapies BU, Baxalta Innovations GmbH, a Takeda company, Vienna, 
      Austria.
FAU - Nagy, Andras
AU  - Nagy A
AD  - Plasma-Derived Therapies BU, Baxalta Innovations GmbH, a Takeda company, Vienna, 
      Austria.
FAU - Yel, Leman
AU  - Yel L
AUID- ORCID: 0000-0001-8357-3186
AD  - Plasma-Derived Therapies BU, Takeda Development Center Americas, Inc., Cambridge, 
      MA 02142, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02556775
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220420
PL  - England
TA  - Immunotherapy
JT  - Immunotherapy
JID - 101485158
RN  - 0 (Immunoglobulins)
SB  - IM
MH  - Female
MH  - Humans
MH  - Immunoglobulins
MH  - Pregnancy
MH  - *Pregnant Women
MH  - *Primary Immunodeficiency Diseases
MH  - Prospective Studies
MH  - Registries
OTO - NOTNLM
OT  - IgRT
OT  - PID
OT  - fSCIG
OT  - facilitated subcutaneous immunoglobulin
OT  - immunoglobulin-replacement therapy
OT  - infant
OT  - pregnancy
OT  - primary immunodeficiency diseases
OT  - real-world data
OT  - safety
EDAT- 2022/04/22 06:00
MHDA- 2022/05/14 06:00
CRDT- 2022/04/21 05:21
PHST- 2022/04/22 06:00 [pubmed]
PHST- 2022/05/14 06:00 [medline]
PHST- 2022/04/21 05:21 [entrez]
AID - 10.2217/imt-2021-0336 [doi]
PST - ppublish
SO  - Immunotherapy. 2022 Jun;14(8):609-616. doi: 10.2217/imt-2021-0336. Epub 2022 Apr 
      20.