A real-world assessment of tolerability and treatment outcomes of COVID-19 monoclonal antibodies administered in pregnancy.

Objective

Monoclonal antibodies (mAb) for the treatment of COVID-19, which are available under emergency use authorization (EUA), prevent disease progression and reduce the risks of hospitalization and mortality when given early. Pregnancy is associated with increased rates of severe illness, intensive care unit (ICU) admission, mechanical ventilation, preterm birth, stillbirth, and death compared with nonpregnant women of reproductive age. , Despite a paucity data on tolerability and outcomes, the American College of Obstetricians and Gynecologists and the Society of Maternal Fetal Medicine support the recommendation from the National Institutes of Health to offer mAb to pregnant individuals with mild-to-moderate COVID-19 infections. To date, there are only 2 published studies on mAb treatment outcomes during pregnancy. , The objectives of this study were to evaluate the tolerability of mAb treatment during pregnancy and to assess the subjective improvement in symptoms, admission within 30 days for COVID or non-COVID reasons, and the pregnancy outcomes.

Study Design

A single-center retrospective observational chart review was conducted for all pregnant persons with mild-to-moderate COVID-19 treated with monoclonal antibodies (bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab) at our medical center between December 2020 and October 2021. The tolerability; infusion-related reactions; and self-reported subjective improvement in symptoms 1–7 days after infusion; 30 days posttreatment admission for COVID or non-COVID reasons; and the pregnancy outcomes where available were analyzed. Patients were considered fully vaccinated if presenting 2 weeks or more following the receipt of 2 doses of an mRNA COVID vaccine or 1 dose of an adenoviral vector-based COVID-19 vaccine.

Results

Of the 30 pregnant patients treated, 25 (83%) reported a subjective improvement in symptoms within 1 to 7 days after infusion (Table). Ten (33%) patients were admitted within 30 days posttreatment. Two (7%) patients with COVID-related admissions within 30 days required supplemental oxygen; neither developed severe infections. Both subsequently delivered at full term by cesarean delivery and were discharged home. Eight were admitted for non-COVID-related issues, 3 for full-term vaginal deliveries, 1 for management of urinary tract infection, 2 deliveries because of category II fetal heart rate tracing patterns prompting interventions (1 vaginal preterm, 1 cesarean full term), and 2 additional preterm deliveries because of preterm premature rupture of membranes. Only 1 patient reported an infusion reaction with mild hypotension and dizziness, which was resolved with fluids. Twenty-two (73%) patients had delivered by November 2021 with 15 vaginal and 4 cesarean full-term deliveries and 2 vaginal and 1 cesarean preterm deliveries. One preterm infant delivered because of preterm premature rupture of membrane required neonatal ICU admission. To date, all 22 mother–baby pairs remain stable without any abnormalities reported in infant growth and anatomy or postpartum COVID-related complications. Six (20%) remain pregnant, and 2 (7%) terminated their pregnancy by choice. No significant adverse pregnancy outcomes were reported.

Table

Characteristics of SARS-CoV-2–positive pregnant patients treated with monoclonal antibodies, February 1, 2021 to October 31, 2021

Characteristics	Total n (%) n=30
Age, median (IQR)	31.5 (25.3–38.5)
Race/ethnicity
Hispanic	4 (0.13)
Non-Hispanic Black	19 (63.3)
Non-Hispanic White	6 (0.2)
Asian	1 (0.03)
Other	0 (0)
BMI (kg/m2)	31 (26–35)
Fully vaccinated before treatment	1 (3)
High-risk comorbidities per EUAa
BMI ≥25 (kg/m2)	24 (80)
Pregnancy	30 (100)
Chronic lung disease	11 (37)
Chronic kidney disease	0 (0)
Diabetes mellitus	2 (7)
Immunocompromised disease or immunosuppressive treatment	0 (0)
Medical-related technological dependence	0 (0)
Neurodevelopmental disorders	0 (0)
Cardiovascular disease or hypertension	1 (3)
Number of EUA criteria met, median	2
Symptom duration before treatment
Days, median (IQR)	3 (2–6)
Asymptomatic, n (%)	1 (3)
Monoclonal antibody product administered
Bamlanivimab	9 (30)
Bamlanivimab/etesevimab	1 (3)
Casirivimab/imdevimab	20 (67)
Outcomes
All-cause 30-d admission	10 (33)
COVID-related 30-d admission	2 (7)
Infusion reactions	1 (3)
Subjective symptom improvement	25 (83)
Delivered	22 (73)
Preterm	3 (14)
Full term	19 (86)
Cesarean	5 (23)
Vaginal	17 (77)
Remains pregnant	6 (20)
Terminated pregnancy by choice	2 (7)
Adverse pregnancy outcome	0 (0)

BMI, body mass index; EUA, emergency use authorization; IQR, interquartile range.

Chang. A real-world assessment of tolerability and treatment outcomes of COVID-19 monoclonal antibodies administered in pregnancy. Am J Obstet Gynecol 2022.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.

Conclusion

Pregnancy is a risk factor for severe COVID-19 and meets EUA criteria for mAb treatment. Monoclonal antibodies are well-tolerated, effective, may benefit the fetus, and should be considered in pregnancy. This study supports the favorable safety and tolerability profile reported in earlier studies. Although 2 oral antivirals are now available, 1 is not indicated in pregnancy, and the other is affected by limited supplies.