Johnson & Johnson has announced that six abstracts, including an oral poster presentation, will be presented at the 35th International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) World Congress in Cancún, Mexico. The presentations will focus on ongoing unmet needs in maternal fetal immunology, specifically highlighting conditions such as hemolytic disease of the fetus and newborn (HDFN) and fetal neonatal alloimmune thrombocytopenia (FNAIT).
Alloantibody diseases like HDFN and FNAIT occur when a pregnant person’s immune system produces antibodies that cross the placenta. In HDFN, these antibodies attack fetal red blood cells; in FNAIT, they target fetal or newborn platelets. Both conditions can have severe consequences for mother and child.
“For families navigating pregnancies affected by HDFN and FNAIT, the experience is often filled with fear and uncertainty and presents an additional burden of self-advocacy. Earlier diagnosis, greater awareness of the diseases and access to innovative therapies have the potential to transform outcomes for thousands of parents and newborns,” said Bethany Weathersby, Founder and Executive Director of The Allo Hope Foundation. “The new patient insights presented at ISUOG show patients feel the intense need to advocate for themselves in the face of fragmented care and uncertainty following diagnosis, reinforcing a critical need to transform care pathways so no patient has to navigate this journey feeling unsupported in the future.”
Recent studies examine treatment patterns such as intrauterine transfusions (IUTs), which are currently standard for managing HDFN, as well as challenges faced during FNAIT diagnosis.
“Despite the severity of these conditions, there are no approved therapeutics that are effective and have a proven safety profile to help address the serious health consequences of HDFN and FNAIT,” said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader for Rheumatology and Autoantibody at Johnson & Johnson Innovative Medicine. “These new patient insights presented at ISUOG confirm the acute need for earlier diagnosis and intervention to deliver the care these patients deserve.”
Johnson & Johnson’s investigational therapy nipocalimab received U.S. FDA Breakthrough Therapy designation for severe HDFN in February 2024 (https://www.jnj.com/media-center/press-releases/johnson-johnsons-nipocalimab-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-individuals-at-high-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn), along with Fast Track designations for both severe HDFN (July 2019) and FNAIT (March 2024) (https://www.jnj.com/media-center/press-releases/johnson-johnsons-nipocalimab-granted-u-s-fda-fast-track-designation-to-reduce-the-risk-of-fetal-neonatal-alloimmune-thrombocytopenia-fnait-in-alloimmunized-pregnant-adults). Clinical trials are ongoing: The Phase 3 AZALEA trial is enrolling pregnant individuals at risk for severe HDFN (https://clinicaltrials.gov/study/NCT05912517), while FREESIA-1 (https://clinicaltrials.gov/study/NCT06449651) and FREESIA-3 (https://clinicaltrials.gov/study/NCT06533098) trials are recruiting those at risk for FNAIT.
HDFN is a rare condition where maternal antibodies attack fetal red blood cells causing anemia; if untreated by experienced clinicians it can lead to serious complications including heart failure or death before birth. After delivery infants may require transfusions due to persistent anemia or hyperbilirubinemia. Severity tends to increase with each subsequent pregnancy.
There are currently no non-surgical interventions approved in the U.S. for pregnancies at high risk of severe HDFN; repeated IUTs may be necessary but carry risks including a reported 1–3% chance per procedure of fetal death according to British Society of Hematology guidelines.
FNAIT is also rare but potentially life-threatening; maternal antibodies against platelet antigens cause low platelet counts which can result in bleeding complications—including intracranial hemorrhage—which occurs in up to 26% of untreated cases. There are no approved therapies specific for FNAIT management; current options like intravenous immunoglobulin improve survival but do not fully address safety concerns.
The investigational drug nipocalimab is designed as a monoclonal antibody targeting FcRn receptors—potentially reducing harmful IgG antibody levels without affecting other immune functions—and aims to limit transplacental transfer from mother to fetus.
The ISUOG presentations will include data on healthcare resource utilization related to HDFN in Sweden, lived experiences from interviews with affected families, clinical outcomes after intrauterine transfusion treatments, evidence from U.S claims data regarding treatment patterns, psychosocial impacts reported by patients with HDFN during an ongoing council study session, as well as qualitative experiences detailing diagnostic challenges associated with FNAIT.
Further information about Johnson & Johnson’s work can be found at https://www.jnj.com/ or https://innovativemedicine.jnj.com/.