Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn

In early onset severe hemolytic disease of the fetus and newborn (HDFN), maternal IgG alloantibodies cross the placenta, causing fetal anemia. In this phase 2, international, open label study, 13 pregnancies at high risk for recurrent HDFN received weekly intravenous nipocalimab from 14 to 35 weeks’ gestation. The primary outcome live birth at ≥32 weeks without intrauterine transfusions occurred in 7 of 13 pregnancies (54%). No cases of fetal hydrops occurred. The treatment showed promise in reducing transfusions and alloantibody levels without unusual infections, supporting its further evaluation.

In early onset severe hemolytic disease of the fetus and newborn (HDFN), maternal IgG alloantibodies cross the placenta, causing fetal anemia. In this phase 2, international, open label study, 13 pregnancies at high risk for recurrent HDFN received weekly intravenous nipocalimab from 14 to 35 weeks’ gestation. The primary outcome live birth at ≥32 weeks without intrauterine transfusions occurred in 7 of 13 pregnancies (54%). No cases of fetal hydrops occurred. The treatment showed promise in reducing transfusions and alloantibody levels without unusual infections, supporting its further evaluation.