OBJECTIVE: The World Health Organization has reported over 6 million COVID-related deaths, including over 300 cases in the pregnant population in the United States alone.1 In November 2020, Emergency Use Authorization of monoclonal antibodies (mAb) was issued for patients with mild-to-moderate COVID-19 at risk of progression to severe disease given favorable reports in at-risk nonpregnant adults who received these agents.2 The US Food and Drug Administration later added pregnancy to this high-risk category.3 However, the use of mAb in pregnant individuals was challenged by the scarcity of evidence, limited availability, and increased prevalence of mAb-resistant strains. Consequently, the literature behind using mAb for COVID-19 during pregnancy remained scant compared with nonpregnant adults.4 Closing this gap is critical for counseling pregnant individuals who may benefit from this treatment modality as new strains emerge. Therefore, our study objectives were to report on the tolerability, rate of hospitalization for disease progression, and pregnancy outcomes of the largest single cohort of pregnant individuals receiving mAb treatment for COVID-19.
STUDY DESIGN: We conducted a single-center retrospective review of pregnant individuals who received mAb treatment for mild-to-moderate COVID-19 at our institution from May 2021 to May 2022. Patients were identified from an institutional COVID-19 registry following approval by the University of South Florida Institutional Review Board. Patients were considered vaccinated if they had received 2 doses of a messenger RNA COVID-19 vaccine or 1 dose of an adenoviral vector–based COVID-19 vaccine. Mild-to-moderate COVID-19 was defined as presence of flu-like symptoms, abnormal imaging and/or refractory fever while maintaining oxygen saturation of 94% or higher on room air. We obtained maternal age, body mass index, parity, gestational age at diagnosis, latency to treatment, treatment setting, mAb type, mAb administration route, and COVID-19-related hospitalizations for progression to severe disease following treatment. We assessed mAb tolerability based on the rate of mAb infusion–related reactions, defined as any signs or symptoms experienced during or immediately after mAb treatment. In addition, we obtained medical comorbidities, pregnancy-related complications, delivery mode, and postpartum complications.
RESULTS: A total of 370 pregnancies were diagnosed with SARS-CoV-2. Within this group, 103 patients with mild or moderate disease received mAb therapy. One patient experienced an infusion-related reaction characterized by transient hot flush, chest discomfort, and shortness of breath that resolved with intravenous diphenhydramine. Similarly, only 1 patient required hospital admission due to progression to severe disease following treatment. No maternal deaths occurred. A summary of sociodemographic characteristics and clinical outcomes is presented in Table.
Table.
Clinical and sociodemographic characteristics of pregnancies with COVID-19 treated with monoclonal antibodies (N=103)
| Patient factors | Total n (%) n=103 |
|---|---|
| Maternal age (y), mean±SD | 31±6 |
| BMI, mean±SD | 32.5±8.5 |
| Parity, median (IQR) | 1 (0–2) |
| Vaccination status | |
| Vaccinated | 34 (33.7) |
| Unvaccinated | 69 (66.3) |
| Gestational age at diagnosis (wk), mean±SD | 26±9.5 |
| Latency to treatment (d), mean±SD | 4±2 |
| Treatment setting | |
| Outpatient | 84 (82.4) |
| Inpatient | 18 (17.6) |
| mAb type | |
| Casirivimab+imdevimab | 90 (87.4) |
| Bebtelovimab | 7 (6.8) |
| Sotrovimab | 2 (1.9) |
| Bamlamivimab+etesevimab | 4 (3.9) |
| Administration route | |
| Intravenous | 81 (79.4) |
| Subcutaneous | 21 (20.6) |
| COVID-19 readmission following mAb treatment | 1 (1) |
| Infusion reaction | 1 (1) |
| Medical comorbiditiesa | |
| Chronic hypertension | 7 (6.9) |
| Type 1 diabetes mellitus | 2 (2) |
| Type 2 diabetes mellitus | 1 (1) |
| Cardiac disease | 4 (3.9) |
| Chronic kidney disease | 1 (1) |
| Asthma | 14 (13.6) |
| Immunosuppressive state | 2 (2) |
| Pregnancy-related complicationsa | |
| Gestational hypertension | 9 (9) |
| Preeclampsia | 5 (5) |
| Gestational diabetes mellitus | 10 (10) |
| Fetal growth restriction | 5 (5) |
| Stillbirth | 1 (1.1) |
| Preterm delivery | 6 (6.5) |
| Peripartum cardiomyopathy | 0 (0) |
| Delivery mode | |
| Vaginal delivery | 58 (56.3) |
| Cesarean delivery | 36 (35.0) |
| Unknown | 9 (8.7) |
| Postpartum complicationsa | |
| Postpartum hemorrhage | 2 (2.2) |
| Chorioendometritis | 3 (3.6) |
| Surgical-site infection | 1 (1.2) |
BMI, body mass index (kg/m2); IQR, interquartile range; mAb, monoclonal antibody; SD, standard deviation.
Values refer to rates for the whole cohort. Therefore, they do not sum up to 100%.
Schenone. Monoclonal antibody for COVID-19 in pregnancy. Am J Obstet Gynecol Glob Rep 2023.
CONCLUSION: This study represents the largest body of evidence to date regarding the use of mAb therapy in pregnant patients with COVID-19. Patients receiving this medication during our study period showed high tolerability and low hospitalization rates for disease progression following treatment. Clinical outcomes in our study aligned with those reported in smaller pregnancy cohorts.4,5 The information provided in this report is critical to minimizing the lack of evidence behind the use of this treatment modality in the pregnant population, an essential step toward improving the counseling of pregnant individuals for whom this therapy is deemed useful.
Footnotes
The authors declare no conflict of interest.
The authors did not receive any financial support for this study.
The authors are not employed by the Federal Government or Armed Forces.
Patient consent was not required because no personal information or details were included.
References
- 1.Centers for Disease Control and Prevention. Data on COVID-19 during pregnancy: severity of maternal illness. 2022. Available at: https://stacks.cdc.gov/view/cdc/119588. Accessed August 5, 2023.
- 2.Jenks JD, Aslam S, Horton LE, et al. Early monoclonal antibody administration can reduce both hospitalizations and mortality in high-risk outpatients with coronavirus disease 2019 (COVID-19) Clin Infect Dis. 2022;74:752–753. doi: 10.1093/cid/ciab522. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Metz TD, Clifton RG, Hughes BL, et al. Disease severity and perinatal outcomes of pregnant patients with coronavirus disease 2019 (COVID-19) Obstet Gynecol. 2021;137:571–580. doi: 10.1097/AOG.0000000000004339. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Chang MH, Cowman K, Guo Y, et al. A real-world assessment of tolerability and treatment outcomes of COVID-19 monoclonal antibodies administered in pregnancy. Am J Obstet Gynecol. 2022;226:743–745. doi: 10.1016/j.ajog.2022.01.018. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Thilagar BP, Ghosh AK, Nguyen J, et al. Anti-spike monoclonal antibody therapy in pregnant women with mild-to-moderate coronavirus disease 2019 (COVID-19) Obstet Gynecol. 2022;139:616–618. doi: 10.1097/AOG.0000000000004700. [DOI] [PMC free article] [PubMed] [Google Scholar]