In a recent study published in VaccinesIn this study, researchers evaluated the impact of monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on maternal and fetal health.
background
Coronavirus disease 2019 (COVID-19) during pregnancy is associated with an increased risk of adverse outcomes. A multicenter study reported that 11% of pregnant women needed intensive care, and 9.3% used a ventilator. Furthermore, affected females exhibit hypertensive disorders, small for children of gestational age, and early pregnancy loss. Vaccination during pregnancy has long been debated and controversial, with low rates of acceptance among pregnant women worldwide.
Monoclonal antibodies (mAbs) have been offered as a treatment option for out-of-hospital COVID-19 patients with mild/moderate disease. The use of mAbs can reduce the autoimmune response against maternal/placental tissues, since SARS-CoV-2 infection can lead to cellular storms and autoantibodies. Clinical trials of mAb use in pregnancy are not available for ethical reasons, and general safety data for use of an anti-SARS-CoV-2 mAb in pregnancy is limited.
about studying
The current study examined pregnancy outcomes after mAb treatment for COVID-19. A literature search was performed in the Web of Science, Cochrane Library, Embase, Medline, Scopus, and Ovid databases using selected terms between December 1, 2019, and August 12, 2022. Data were searched, eligibility, inclusion, risk of bias, and data extracted. Performed by two authors.
Unreviewed peer-reviewed studies were not considered. The team included all case series and retrospective studies evaluating pregnancy, maternal and neonatal/fetal outcomes in a population receiving mAbs for COVID-19. The Newcastle-Ottawa Quality Assessment Scale was used, which measures studies according to 1) selection, 2) comparability of study groups, and 3) ascertainment of outcomes.
Maternal, neonatal, fetal, and delivery outcomes in pregnant women receiving treatment with mAb were evaluated. The primary outcome was the proportion of premature births. Adverse events such as fetal distress, premature rupture of the membrane (PROM), preeclampsia, etc., and maternal and neonatal outcomes, including neonatal resuscitation, jaundice, and death, among others, were also evaluated.
the findings
The researchers screened 53 articles and included 17 studies in the systematic review. Eight studies were conducted in the United States, four in Europe, three in Japan, and two in the United Arab Emirates. In all, these studies included 190 pregnant women with mild to severe COVID-19 who were treated with mAbs. mAbs were administered to 105 outpatients and 81 inpatients. One study did not specify the outpatient/inpatient status of four patients.
Evaluation of study quality revealed an overall good result for selection/comparability of study groups and outcome assessment. Approximately 13% of individuals reported adverse events after mAb infusion. Fetal distress occurred in 4.2% of cases, preeclampsia in 3.4%, and gestational hypertension in 3%. Premature rupture of membranes and premature premature rupture of membranes (pPROM) were observed in 1.6% and 3.4% of cases, respectively.
Growth restriction was observed in 3.2% of fetuses. Preterm births occurred in 22.8% of subjects, although approximately 30% (of those) were due to an exacerbation of a maternal COVID-19 condition. One individual was delivered shortly after mAb infusion. More than 48% of women delivered vaginally, and 4.6% required a surgical delivery. Urgent caesarean section was performed in 12.6% of cases.
Approximately 16% of babies were admitted to the neonatal intensive care unit (NICU), and 30% of newborns required resuscitation. Approximately 27% of neonates were jaundiced and 2.2% died. There was one case of CMV reactivation, which started using antivirals from birth. Overall, the cumulative incidence of maternal, fetal, and neonatal adverse outcomes was estimated to be 36.9%.
conclusions
The authors found that 22.8% of pregnant women receiving mAb therapy were delivered preterm. However, most of these deliveries were due to an exacerbation of maternal COVID-19 unrelated to mAbs. Adverse events after mAb infusion were observed in 12.8% of cases, and approximately 37% of subjects experienced maternal, fetal, neonatal, or delivery adverse outcomes. Study limitations are the small sample size, retrospective nature of the included studies, and heterogeneity.
Furthermore, the researchers were unable to stratify the sample according to SARS-CoV-2 variant infection and vaccination status. The results indicate that anti-SARS-CoV-2 mAbs could be a useful treatment option for pregnant individuals. Although an increased risk of adverse outcomes in pregnancy was not evident, more data with longer follow-up periods are needed.
