There appears to be no significant difference in long-term neurodevelopmental outcomes between patients who received standard hemolytic disease of the fetus and newborn (HDFN) care and those who received darbepoetin alpha, according to a comment on a recently published study in The Lancet.
The authors aimed to assess the neurodevelopmental effects of darbepoetin treatment for HDFN two years after birth. The study consisted of a 24-month follow-up of 43 children who participated in an open-label, single-center, phase 2 trial testing the efficacy of darbepoetin alpha. The patients were divided into two groups: one receiving standard treatment and the other darbepoetin alpha.
The initial study’s results showed that darbepoetin alpha significantly reduced the need for transfusions in patients who received it. Two years later, the authors analysed their neurodevelopmental outcomes in the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley-III).
Researchers observed that the rate of mild-to-moderate neurodevelopmental impairment, defined as the presence of cerebral palsy, Bayley-III cognitive score below 85, and/or mild visual or auditory impairment, was around 16% in both groups. One patient in the standard treatment group had severe neurodevelopmental impairment.
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The authors remarked that the study’s small sample was a limiting factor that could be partly responsible for the results. Therefore, further larger studies are required to confirm the findings.
“We hypothesized that a decrease in the number of transfusion episodes would lead to better neurodevelopmental outcomes,” the authors wrote. “However, this effect could not be demonstrated as this posthoc analysis is limited by a small sample size that was not powered to detect such differences.”
About darbepoetin alpha
Darbepoetin alpha is an erythropoiesis stimulant, which means it binds to receptors in the bone marrow, stimulating it to produce more red cells. The drug has been shown to reduce the need for red blood cell transfusions in patients with HDFN.
Evidence shows that red blood cell transfusion dependency could negatively affect neurodevelopmental development. Therefore, the authors hypothesized that the neurodevelopmental outcomes could be better in patients treated with it.
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