Abstract

In the mid-20th century, Hemolytic Disease of the Fetus and Newborn, caused by maternal alloimmunization to the Rh(D) blood group antigen expressed by fetal red blood cells (i.e., “Rh disease”), was a major cause of fetal and neonatal morbidity and mortality. However, with the regulatory approval, in 1968, of IgG anti-Rh(D) immunoprophylaxis to prevent maternal sensitization, the prospect of eradicating Rh disease was at hand. Indeed, the combination of antenatal and post-partum immunoprophylaxis is ~99% effective at preventing maternal sensitization to Rh(D). To investigate global compliance with this therapeutic intervention, we used an epidemiological approach to estimate the current annual number of pregnancies worldwide involving an Rh(D)-negative mother and an Rh(D)-positive fetus. The annual number of doses of anti-Rh(D) IgG required for successful immunoprophylaxis for these cases was then calculated and compared with an estimate of the annual number of doses of anti-Rh(D) produced and provided worldwide. Our results suggest that ~50% of the women around the world who require this type of immunoprophylaxis do not receive it, presumably due to a lack of awareness, availability, and/or affordability, thereby putting hundreds of thousands of fetuses and neonates at risk for Rh disease each year. The global failure to provide this generally acknowledged standard-of-care to prevent Rh disease, even 50 years after its availability, contributes to an enormous, continuing burden of fetal and neonatal disease and provides a critically important challenge to the international health care system.

Highlights

  • Hemolytic Disease of the Fetus and Newborn (HDFN) is caused by maternal alloimmunization to blood group antigens expressed by fetal red blood cells

  • Most severe cases of HDFN were attributed to Rh(D) incompatibility between an Rh(D)-negative woman and her Rh(D)-positive fetus, with Rh(D) alloimmunization having occurred during a previous pregnancy [2, 3]

  • The annual number of doses of IgG anti-Rh(D) required to provide antenatal and post-partum immunoprophylaxis by Global Burden of Disease (GBD) Super Region is shown in Table 1, together with the total number of annual doses administered and the difference between the number of IgG anti-Rh (D) doses required for post-partum immunoprophylaxis and the number administered (i.e., Δ)

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Summary

Introduction

Hemolytic Disease of the Fetus and Newborn (HDFN) is caused by maternal alloimmunization to blood group antigens expressed by fetal red blood cells. Before 1945, ~50% of all fetuses with hemolytic diseases of various etiologies died of kernicterus or hydrops fetalis [4]. Most severe cases of HDFN were attributed to Rh(D) incompatibility between an Rh(D)-negative woman and her Rh(D)-positive fetus, with Rh(D) alloimmunization having occurred during a previous pregnancy [2, 3]. In the 1960s, studies in the United States and in Great Britain determined that passive immunization of Rh(D)-negative mothers with IgG anti-Rh(D), soon after parturition, could protect women from sensitization against Rh(D)-positive red blood cells [5]. This led to regulatory approval and licensure of IgG anti-Rh(D) preparations for routine post-partum prophylaxis in 1968, more than 50 years ago

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