80202135EBF0001_Non Interventional Outcome of pregnancies with HDFN_2

• Research type

  Research Study

• Full title

  A Historical Cohort, Multicenter Study to Characterize the Management, Clinical Course, and Outcomes of Pregnancies in Women Who Have Experienced a Pregnancy With Early Onset Severe HDFN

• IRAS ID

  324290

• Contact name

  Jason Balderson

• Contact email

  jbalders@its.jnj.com

• Sponsor organisation

  Janssen Research & Development, LLC

• Clinicaltrials.gov Identifier

  EDMS-RIM-925766, 1.0, EDMS Number

• Duration of Study in the UK

  0 years, 8 months, 1 days

• Research summary

  This is a historical cohort, observational study designed to collect health information to gain further understanding on the management, clinical course, and risk of re-occurrence of severe haemolytic disease of the foetus and newborn (HDFN) in women who have had pregnancies with offspring affected by early onset severe (EOS)-HDFN.

  Data will be used for external control comparisons to evaluate the data in the sponsor’s MOM-M281-003 study to evaluate nipocalimab when administered to pregnant women at high risk for EOS-HDFN.
  HDFN may develop when a mother and her unborn baby have different blood types. The types are based on small substances (antigens) on the surface of the red blood cells.

  Data will be collected from the medical charts of eligible women (in the timeframe from 2006 to 2019 at the selected sites) who have had at least one pregnancy affected by EOS-HDFN and who then had at least one subsequent antigen-positive pregnancy. The target is approximately 50 women.

  The study consists of collecting health information already available in the participant’s medical records retrospectively. The study itself has no impact on their care. Participants will not be required to visit the study site.

  Maternal and foetal data will be obtained from the gestational period through birth. If available, neonatal data will be collected up to 12 weeks of age.

  Summary of Results
  Participants with a prior pregnancy affected by severe HDFN remained at substantial risk for recurrent fetal and neonatal morbidity in subsequent antigen-positive pregnancies. A low proportion of pregnancies met the composite endpoint without fetal loss, IUT, hydrops fetalis, or neonatal death, underscoring the persistent clinical burden of disease despite specialized management.
  • Less than 15% of at-risk pregnancies had outcomes without fetal loss (for any reason), IUT, fetal hydrops or neonatal death. 82-85% did result in at least one of these poor outcomes.
  • Fetal loss occurred in 7% and fetal hydrops in 17% of at-risk pregnancies. No neonatal deaths were reported.
  • Less than 20% of at-risk pregnancies achieved a live birth at >32 weeks GA without any IUTs • Less than 20% of at-risk pregnancies had neither IUT(s) nor fetal demise. Conversely more than 80% resulted in IUT(s) or fetal demise.
  • Approximately 15-17% had IUT(s) or fetal demise observed earlier than 20 weeks GA. Approximately 83-84% experienced fetal hydrops or underwent IUT before 28 weeks GA, with a median GA at onset of IUT or fetal hydrops approximately 24 weeks GA.
  • Median GA at first IUT occurred earlier in all at risk (234/7 weeks) and latest at risk (24 0/7 weeks) pregnancies compared to qualifying pregnancies (29 0/7 weeks). The first IUT in at-risk pregnancies occurred at approximately 4 weeks earlier than in the qualifying pregnancies.
  • Overall delivery outcomes were broadly similar despite earlier onset of disease requiring intervention in at-risk pregnancies.
  • Survey responses suggest that experiences associated with HDFN influenced reproductive decision-making in many participants
  

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  23/LO/0678

• Date of REC Opinion

  10 Aug 2023

• REC opinion

  Favourable Opinion