The future options for the prevention and management of fetal and neonatal alloimmune thrombocytopenia (FNAIT) were summarized in a recently published review in Best Practice & Research Clinical Obstetrics & Gynaecology.
FNAIT is caused by maternal antibodies of the IgG class against fetal platelet antigens, often leading to severe fetal thrombocytopenia and risk of intracranial hemorrhage. Despite routine antibody screening and advances in diagnosis, these alloimmune complications remain a major cause of fetal and neonatal morbidity and mortality.
IVIG with or without steroids remains the gold standard to reduce the risk of fetal and neonatal bleeding in pregnancies with FNAIT. The effectiveness of this approach has been confirmed by registry data, meta-analyses, and randomized trials.
“Intravenous immune globulin is useful in improving perinatal outcomes in cases of EOS-HDFN 407 and continues to be the standard treatment for preventing the sequalae of FNAIT,” the authors wrote.
Currently, the field of alloimmune perinatal disorders like FNAIT is at a turning point, with biologics like nipocalimab offering a targeted approach that could transform prevention and management.
New biologic agents such as nipocalimab, a humanized monoclonal antibody that blocks the neonatal Fc receptor (FcRn), are now in advanced clinical trials for both hemolytic disease of the fetus and newborn (HDFN) and FNAIT. FcRn blockade is designed to prevent the transplacental transfer of maternal IgG, thereby protecting the fetus from harmful antibodies.
Ongoing phase III trials are further evaluating nipocalimab’s efficacy and safety. For FNAIT, early-phase studies of nipocalimab are underway, comparing its effects with IVIG, aiming to establish it as a future alternative therapy.
However the authors remarked that some questions remain regarding optimal patient selection, long-term neonatal outcomes, and the comparative effectiveness of biologics versus established treatments.
“The outcomes of a subsequent ongoing phase III 410 clinical trial in HDFN and planned trials in FNAIT are awaited to prove the safety and efficacy 411 in the treatment of these alloimmune diseases in pregnancy,” the authors wrote.
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