In a recent study published in Springer, researchers evaluated coronavirus disease 2019 (COVID-19) monoclonal antibody (mAb) treatment in pregnant and postpartum women.
Study: Treatment with anti-SARS-CoV-2 monoclonal antibodies in pregnant and postpartum women: first experiences in Florence, Italy. Image Credit: M M Vieira/Shutterstock
Background
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 females were later classified as highly susceptible to disease with an increased risk of developing severe COVID-19.
According to some studies, pregnant women were at higher odds of intensive care unit (ICU) admission and death; moreover, children born to infected mothers were more likely to require neonatal ICU. Pregnant individuals were not included for COVID-19 vaccinations in the beginning due to the lack of data on safety and efficacy. Nonetheless, by mid-2021, they were recommended for vaccination. The relative delay in covering pregnant populations under the vaccination program and vaccine-hesitancy among sections of the society put them at risk for SARS-CoV-2 infection.
COVID-19 mAb treatment began in March 2021, in Italy, initially for outpatients with mild to moderate disease, at risk of developing severe disease, within the 10 days of onset of symptoms. With an increase in positive results for inpatients, a higher mAb dose was authorized by the Agenzia Italiana del Farmaco (AIFA) for seronegative, hospitalized patients without the need for mechanical ventilation or high flow oxygen. Later on, the National Institutes of Health (NIH) guidelines stated that pregnant individuals should be managed in the same way as non-pregnant patients, including mAb use.
The study
The current research reported COVID-19 patient outcomes in pregnant females given mAb therapy at the infectious and tropical diseases unit of the Careggi University Hospital, Italy. The electronic medical records of pregnant COVID-19 patients treated (with mAbs) were obtained between March 1, 2020, and September 30, 2021. Pregnant and postpartum patients treated with casirivimab/imdevimab were included in the study. A 2.4 g dose was authorized for patients who did not require hospitalization, while 8 g was authorized for hospitalized patients.
Ten patients were given mAbs during the study period, of which two were outpatients and eight were inpatients. 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 postpartum. None were vaccinated with a median body mass index (BMI) of 24.8 kg/m2 and one median comorbid condition.
The most common comorbidity was excess weight indicated by 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 in the 2.4 g dosage regimen and the remaining in the 8 g regimen. They received mAbs after two median days post-onset of symptoms. No adverse responses to mAb therapy were observed, and recovery was quick without complications. Four inpatients required low flow oxygen, and three were treated with steroids. One patient showed myocarditis, a possible COVID-19 complication. None were admitted to the intensive care unit (ICU).
Uncomplicated deliveries were recorded for five patients, two premature deliveries because of 1) premature rupture of membranes and 2) pre-eclampsia necessitating cesarean section (C-section). Another patient who required C-section due to fetal pathological cardiotocographic trace had an asymptomatic neonate. Mild postpartum bleeding was observed for one patient. One newborn developed mild, transient neonatal jaundice, and another required transitory admission to pediatric ICU. Nonetheless, these complications were unrelated to the use of mAbs based on the onset of events and time of administration.
Conclusions
The researchers observed no adverse reactions to mAbs for COVID-19 treatment in pregnant women. This is in line with other recent reports on mAb therapy for pregnant females reporting good efficacy of mAbs without any major adverse effect. The authors also included postpartum patients at risk of developing severe disease in the first few days following delivery.
It is noteworthy that the small sample size of the study without a control group does not, in general, provide conclusive evidence on the safety and efficacy profile of the mAbs for COVID-19 treatment in pregnant individuals. However, none of the patients here showed severe disease manifestation.
In summary, the present study suggested that mAbs can be used to treat pregnant and postpartum COVID-19 inpatients and outpatients in the early stages of the disease.
Oregon study finds no clear link between mRNA vaccines and sudden cardiac deaths in young people