Hemolytic disease of the fetus and newborn (HDFN) is a severe disorder caused by maternal antibodies against fetal RBC antigens causing hemolytic anemia. Rh immunoglobin prophylaxis has reduced the number of cases, and intrauterine transfusions have reduced mortality. However, more than 80% of infants with HDFN who received intrauterine transfusions require additional RBC transfusions after birth. Since observational studies have found conflicting results on the effect of erythropoiesis stimulating agents such as darbepoetin alfa among infants with HDFN, researchers in the Netherlands conducted an open-label, single-center, randomized-controlled trial. Between 2017 and 2022, the study enrolled 44 infants (>35 weeks gestation) at birth with HDFN who received intrauterine transfusions; infants were randomized to receive 10 µg/kg of darbepoetin alfa subcutaneously once a week for 4 to 8 weeks (n=20) or standard care (n=24). After three months, infants in the darbepoetin alfa arm received fewer transfusions than those in the standard care arm (median of 1.0 [IQR, 1.0 to 2.0] vs 2.0 [IQR, 1.3 to 3.0] transfusion episodes; p=0.008). No safety concerns were noted, but additional studies are needed to confirm that darbepoetin alfa is safe and reduces the need for RBC transfusions in infants with HDFN.
References:
- Ree IMC, Haas M de, Geloven N van, Juul SE, Winter D de, Verweij EJT, et al. Darbepoetin alfa to reduce transfusion episodes in infants with haemolytic disease of the fetus and newborn who are treated with intrauterine transfusions in the Netherlands: an open-label, single-centre, phase 2, randomised, controlled trial. The Lancet Haematology. 2023 Dec 1;10(12):e976–84.
- Patel RM, Ohls R. Use of darbepoetin alfa in haemolytic disease of the fetus and newborn. The Lancet Haematology. 2023 Dec 1;10(12):e943–5.
