Paediatric outcomes after maternal nipocalimab for haemolytic disease of the fetus and newborn: an open-label, single-arm study.

Authors

Derek P de Winter, Kenneth J Moise, Leona E Ling, Dick Oepkes, Eleonor Tiblad, E J T Joanne Verweij, John Smoleniec, Ulrich J Sachs, Gregor Bein, Mark D Kilby, Russell S Miller, Roland Devlieger, Anne Debeer, Jocelyn H Leu, Robert M Nelson, Valerie Smith, Lisa B Schwartz, May Lee Tjoa, Yosuke Komatsu, Shumyla Saeed-Khawaja, Enrico Lopriore, UNITY Study Group

Published in

Archives of disease in childhood. Fetal and neonatal edition. Sep 07, 2026. Epub Sep 07, 2026.

Abstract

To describe haemolytic disease outcomes, growth, neurodevelopment and health-related quality of life (HRQoL) through 24 months of life in infants exposed to nipocalimab in pregnancies at high risk of early-onset severe haemolytic disease of the fetus and newborn (EOS-HDFN).
A multicentre, open-label, single-arm trial.
Centres with expertise in HDFN management.
Pregnant individuals with previous EOS-HDFN and maternal anti-D titres ≥32 or anti-K titres ≥4.
Weekly nipocalimab (30 and/or 45 mg/kg) from 14 to 35 gestational weeks.
Infants' cord-blood alloantibody titres at birth, HDFN management, growth through 6 months, neurodevelopment (caregiver-reported Ages and Stages Questionnaire, third edition (ASQ-3)) and HRQoL assessments through 24 months of life.
Of 13 pregnancies, 12 resulted in live births; one fetal loss occurred due to intrauterine transfusion (IUT) complications. A single simple transfusion was administered in one of seven infants delivered after a maternal nipocalimab course without IUTs, where cord blood alloantibody titres were <8. Multiple transfusions (one to seven simple transfusions/infant; one exchange transfusion) were administered to five infants delivered after early nipocalimab discontinuation and IUTs, with cord-blood alloantibody titres ranging from 512 to 32 768. No unusual growth patterns were observed through 6 months. No neurodevelopmental delays were identified through 24 months of life, with mean ASQ-3 domain scores within normal ranges. HRQoL outcomes were positive across physical, emotional, social and cognitive functioning.
Maternal nipocalimab in pregnancies at high risk of EOS-HDFN may reduce adverse neonatal outcomes correlating with low cord-blood alloantibody titres, without affecting growth through 6 months, neurodevelopment or HRQoL through 24 months of life.
NCT03842189.

PMID:
42705868
Bibliographic data and abstract were imported from PubMed on 08 Sep 2026.

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