Special editorial submitted by champion steward partner, Johnson & Johnson
Hemolytic disease of the fetus and newborn (HDFN) is a rare and potentially life-threatening disease where maternal antibodies, or alloantibodies, produced in a pregnant person’s immune system cross the placenta and attack fetal red blood cells — causing fetal hemolysis leading to anemia.1 According to the American Journal of Obstetrics and Gynecology, in the U.S., up to 80 out of every 100,000 pregnancies are affected by HDFN every year.² HDFN can lead to serious health complications for the baby, such as anemia, jaundice, or edema (fluid buildup). The severe form of HDFN can lead to hydrops fetalis, which is a condition in which large amounts of fluid buildup in the fetus or neonate’s tissues and organs, which can be life threatening.
HDFN is caused when there is a mismatch in red blood cell antigens of the pregnant person and fetus, or maternal alloimmunization – the most common causes of which is blood transfusion and pregnancy. Typically, HDFN does not develop in the mother’s first pregnancy because the baby is born before many of the antibodies have been produced. HDFN occurs most often in later pregnancies, after the mother’s immune system has already developed antibodies from an earlier pregnancy.
Determined to protect what matters most Have you experienced a hemolytic disease of the fetus and newborn (HDFN) pregnancy? If so, it’s normal to feel concerned about the health of your next child. Researchers are currently conducting a research study. Consider joining the Phase 3 AZALEA trial, a clinical trial currently enrolling women who are at risk for severe HDFN who have a history of severe HDFN in a prior pregnancy.
You may be able to participate in the AZALEA trial if you:
• have tested positive for red cell antibodies
• have been diagnosed with HDFN in a prior pregnancy
• are 18 to 45 years old
If you are interested in participating, the trial doctor or staff will review additional information with you to assess if you can join the study.
“There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN,” said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson, “Our aspiration is to transform the existing paradigm for families who endure the consequences of this potentially devastating disease.”
1 Hemolytic disease of the newborn. Medline Plus. Accessed: November 18, 2022. https://medlineplus.gov/ency/article/001298. htm.
2 Delaney M and Matthews D. Hemolytic disease of the fetus and newborn: managing the mother, fetus, and newborn. Hematology Am Soc Hematol Educ Program (2015) 2015 (1): 146–151. doi: https://doi.org/10.1182/asheducation-2015.1.146.
