In a recent study published in Springerresearchers evaluated coronavirus disease 2019 (COVID-19) monoclonal antibody (mAb) treatment in pregnant and postpartum women.
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has been a major public health emergency for two years now. Comorbid individuals were recognized as vulnerable to infection in the early pandemic; Pregnant and postpartum women were later classified as highly susceptible to disease with an increased risk of developing severe COVID-19.
According to some studies, pregnant women had higher odds of admission to the intensive care unit and death; in addition, children born to infected mothers were more likely to require neonatal intensive care unit. Pregnant women were not initially included in COVID-19 vaccinations due to lack of data on safety and efficacy. Nevertheless, in mid-2021, they were recommended for vaccination. The relative delay in coverage of pregnant populations during the vaccination program and vaccine hesitation among sections of society put them at risk of SARS-CoV-2 infection.
COVID-19 mAb treatment started in March 2021, in Italy, initially for outpatients with mild to moderate disease, at risk of developing serious illness, within 10 days after the onset of symptoms. With an increase in positive outcomes for inpatients, a higher mAb dose was approved by Agenzia Italiana del Farmaco (AIFA) for seronegative inpatients without the need for mechanical ventilation or high-flow oxygen. Later, National Institutes of Health (NIH) guidelines stated that pregnant women should be treated in the same way as non-pregnant patients, including mAb use.
The current research reported COVID-19 patients in pregnant women who received mAb treatment at the Department of Infectious and Tropical Diseases at Careggi University Hospital, Italy. The electronic records of pregnant COVID-19 patients treated (with mAbs) were obtained between 1 March 2020 and 30 September 2021. Pregnant and postpartum patients treated with casirivimab / imdevimab were included in the study. A dose of 2.4 g was approved for patients who did not require hospitalization, while 8 g was approved for hospitalized patients.
Ten patients received mAbs during the study period, two of whom were outpatients and eight were hospitalized. The median age was 31 years with a mean gestational age of 24 weeks. Eight patients were treated during their pregnancy and two were treated after delivery. No one was vaccinated with a median body mass index (BMI) of 24.8 kg / m2 and a median comorbid condition.
The most common comorbidity was obesity reported at a BMI> 25 kg / m2. Four patients developed the severe clinical disease; six had a moderate illness. SARS-CoV-2 variant data, available for nine patients, revealed infection B.1.167.2 (Delta) variant for all patients.
Five patients were on the 2.4 g dose regimen and the remainder on the 8 g regimen. They received mAbs after two median days after the onset of symptoms. No adverse reactions to mAb therapy were observed and recovery was rapid with no complications. Four hospitalized patients required low-flow oxygen, and three were treated with steroids. One patient showed myocarditis, a possible COVID-19 complication. No one was admitted to the intensive care unit (ICU).
Uncomplicated births were recorded for five patients, two premature births due to 1) premature rupture of membranes and 2) preeclampsia necessitating caesarean section (cesarean section). Another patient who required a cesarean section due to fetal pathological cardiotocographic traces had an asymptomatic neonate. Mild postpartum haemorrhage was observed in one patient. One newborn developed mild, transient neonatal jaundice, and another required temporary hospitalization in the pediatric intensive care unit. Nevertheless, these complications were not related to the use of mAbs based on the onset of events and the time of administration.
The researchers observed no side effects on mAbs for COVID-19 treatment in pregnant women. This is in line with other recent reports of mAb treatment for pregnant women reporting good efficiency of mAbs without any major negative effect. The authors also included postpartum patients at risk of developing serious illness in the first few days after birth.
It is noteworthy that the small sample size of the study without a control group generally does not provide conclusive evidence for the safety and efficacy profile of mAbs for COVID-19 treatment in pregnant women. But none of the patients here showed severe disease manifestation.
In summary, the current study suggested that mAbs could be used to treat pregnant and postpartum COVID-19 inpatients and outpatients in the early stages of the disease.