PMID- 36156812
OWN - NLM
STAT- MEDLINE
DCOM- 20221222
LR  - 20230415
IS  - 1096-8652 (Electronic)
IS  - 0361-8609 (Print)
IS  - 0361-8609 (Linking)
VI  - 98
IP  - 1
DP  - 2023 Jan
TI  - Romiplostim use in pregnant women with immune thrombocytopenia.
PG  - 31-40
LID - 10.1002/ajh.26743 [doi]
AB  - Treatment for immune thrombocytopenia (ITP) in pregnancy is hampered by the lack 
      of fetal safety evidence of maternally-administered medications. The Pregnancy 
      Surveillance Program (PSP) collected patient information from 2017-2020 for 
      pregnancy, birth outcomes, and adverse events (AEs) for 186 women exposed to 
      romiplostim from 20 days before pregnancy to the end of pregnancy. Timing of 
      exposure was available in 128 women. Seventy-one mothers (38%) had prepregnancy 
      exposure to romiplostim; intrapartum exposure was known for the first (for many 
      mothers when they discovered their pregnancy), second, and third trimesters for 
      74 (40%), 22 (12%), and 44 (24%) mothers, respectively, with 15 mothers exposed 
      during >1 trimester. Among the 86 mothers with known pregnancy outcomes, 46 (53%) 
      had at least one pregnancy-related serious AE (SAE); approximately 2/3 of SAEs 
      were due to underlying ITP. Of 92 mothers with known birth outcomes, 60 (65%) had 
      a normal pregnancy and 16 (17%) had complications, with both categories including 
      term and preterm births; there were 12 (14%) spontaneous 
      miscarriages/stillbirths, 3 (3%) ectopic pregnancies, and 1 (1%) molar pregnancy. 
      Most abnormal births resulted from abnormal pregnancies. There were five 
      neonatal/postnatal AEs of note: inguinal hernia, cytomegalovirus infection, 
      trisomy 8 (third trimester single-dose romiplostim exposure), single umbilical 
      artery without known anomalies, and development of autism at age 2 years. Seven 
      of 12 infants with neonatal thrombocytopenia had resolution of thrombocytopenia 
      before discharge; all 12 were discharged. Review of pregnancies in women exposed 
      to romiplostim did not reveal any specific safety concerns for mothers, fetuses, 
      or infants.
CI  - (c) 2022 The Authors. American Journal of Hematology published by Wiley Periodicals 
      LLC.
FAU - Bussel, James B
AU  - Bussel JB
AUID- ORCID: 0000-0002-2884-9247
AD  - Weill Cornell Medicine, New York, New York, USA.
FAU - Cooper, Nichola
AU  - Cooper N
AUID- ORCID: 0000-0002-9845-8292
AD  - Hammersmith Hospital, London, UK.
FAU - Lawrence, Tatiana
AU  - Lawrence T
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Michel, Marc
AU  - Michel M
AUID- ORCID: 0000-0002-9822-7400
AD  - Henri Mondor University Hospital, Universite Paris-Est Creteil, France.
FAU - Vander Haar, Emilie
AU  - Vander Haar E
AD  - Weill Cornell Medicine, New York, New York, USA.
FAU - Wang, Kejia
AU  - Wang K
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Wang, Hongmei
AU  - Wang H
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Saad, Hossam
AU  - Saad H
AD  - Amgen Inc., Thousand Oaks, California, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221010
PL  - United States
TA  - Am J Hematol
JT  - American journal of hematology
JID - 7610369
RN  - GN5XU2DXKV (romiplostim)
SB  - IM
MH  - Infant
MH  - Infant, Newborn
MH  - Pregnancy
MH  - Female
MH  - Humans
MH  - Child, Preschool
MH  - *Purpura, Thrombocytopenic, Idiopathic/drug therapy/complications
MH  - Pregnant Women
MH  - *Thrombocytopenia/etiology
MH  - Pregnancy Outcome
PMC - PMC10091785
COIS- James B. Bussel has participated in advisory boards and received consultancy fees 
      from Amgen Inc., Novartis, Dova, Rigel, UCB, Argenx, Momenta, Regeneron, Kezar, 
      Principia, and CSL-Behring; has participated in speakers bureaus with Novartis 
      and 3S Bio; and has received honoraria from UpToDate. Nichola Cooper has received 
      honoraria for speaking engagements; has participated in advisory boards with 
      Novartis, Amgen Inc., Rigel, and Principia; and has received support for clinical 
      trials from Amgen Inc., Novartis, Rigel, Principia, and UCB. Tatiana Lawrence, 
      Kejia Wang, Hongmei Wang, and Hossam Saad are employees and stockholders of Amgen 
      Inc. Marc Michel has received consultancy fees from Amgen Inc. and Novartis and 
      honoraria from Rigel, Argenx, UCB, and Alexion. Emilie Vander Haar has no 
      disclosures.
EDAT- 2022/09/27 06:00
MHDA- 2022/12/23 06:00
PMCR- 2023/04/12
CRDT- 2022/09/26 16:54
PHST- 2022/09/14 00:00 [received]
PHST- 2022/09/21 00:00 [accepted]
PHST- 2022/09/27 06:00 [pubmed]
PHST- 2022/12/23 06:00 [medline]
PHST- 2022/09/26 16:54 [entrez]
PHST- 2023/04/12 00:00 [pmc-release]
AID - AJH26743 [pii]
AID - 10.1002/ajh.26743 [doi]
PST - ppublish
SO  - Am J Hematol. 2023 Jan;98(1):31-40. doi: 10.1002/ajh.26743. Epub 2022 Oct 10.