Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy

McCreary, Erin K; Lemon, Lara; Megli, Christina; Oakes, Amber; Seymour, Christopher W.

doi:10.7326/m22-1329

Cited by 11 publications

(6 citation statements)

References 30 publications

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“…In our series, a pregnant woman in active labor was also treated, and the study demonstrated a certain safety of monoclonal antibodies, such as not affecting breastfeeding in the first few days. These data are in agreement with previous data that showed the absence of serious treatment-related adverse events [ 10 , 35 , 36 , 37 ]. The low frequency of maternal–fetal adverse events may be explained by the younger age of the patients with few comorbidities and the exchanged maternal IgG between the mother and the newborn during the first few days after birth.…”

Section: Discussionsupporting

confidence: 93%

“…The first studies evaluating and reporting outcomes of pregnant women with COVID-19 and conducted with the combinations of Bamlanivimab/etesevimab and Casirivimab/imdevimab observed that monoclonal antibodies were well-tolerated and no adverse mother-fetus effects were reported [10,35,36]. Furthermore, another study similar to ours showed that adverse events after monoclonal antibody treatment were mild and rare [37]. However, neonatal outcomes have not been fully described due to a short follow-up period, while our study had a period of follow-up that was prolonged until 6 months.…”

Section: Discussionsupporting

confidence: 68%

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Use of Monoclonal Antibodies in Pregnant Women Infected by COVID-19: A Case Series

Crispino,

Marocco,

Di Trento

et al. 2023

Microorganisms

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Background: Monoclonal antibodies are designed to target specific proteins of COVID-19 and can be used as a treatment for people with mild to moderate infection and at a high risk of severe disease. Casirivimab/imdevimab, sotrovimab, and Bamlanivimab/etesevimab have been authorized for emergency use in the treatment of COVID-19. However, during pregnancy, these drugs have not been extensively studied. Methods: A total of 22 pregnant women with mild to moderate infection were treated with three different monoclonal antibodies, and efficacy and safety were evaluated in the first period and until six months of follow-up. Results: No infusion/allergic reactions occurred. No fatal or adverse events were observed in the pregnant women or fetus. The time of negativization with sotrovimab was shorter in comparison to Imdevimav/casirivimab (p = 0.0187) and Bamlanivimab/etesevimab (p < 0.00001). The time of negativization with sotrovimab was earlier in comparison to Imdevimav/casirivimab (t-value: 2.92; p = 0.0052) in vaccinated patients and similar in comparison to Imdevimav/casirivimab (t-value: 1.48; p = 0.08). In unvaccinated patients, sotrovimab was faster to achieve negativization in comparison to Bamlanivimab/etesevimab (t-value: 10.75; p < 0.0005). Conclusions: Pregnant COVID-19 patients receiving sotrovimab obtained better clinical outcomes. Pregnancy or neonatal complications were not observed after monoclonal treatment, confirming the safety and tolerability of these drugs in pregnant women.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 68%

Use of Monoclonal Antibodies in Pregnant Women Infected by COVID-19: A Case Series

Crispino,

Marocco,

Di Trento

et al. 2023

Microorganisms

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“…The study demonstrated that adverse events after monoclonal antibody treatment were mild and rare. In addition, there was no difference in obstetric-related safety outcomes or COVID-19-related outcomes and non-COVID-19 related hospital admissions between the two arms [ 11 ]. Notably, neonatal outcomes were not fully described due to a short follow-up period.…”

Section: Conclusion and Discussionmentioning

confidence: 99%

Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO)

et al. 2023

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Background Sotrovimab, a monoclonal antibody with efficacy against SARS-CoV-2 including certain Omicron variants, has been used in treatment of mild-moderate COVID-19. Limited data exists regarding its use in pregnant women. Methods Electronic medical record review of pregnant COVID-19 patients treated with sotrovimab from 12/30/21 − 1/31/22 (Yale New Haven Health Hospital System [YNHHS]) was performed. Included were pregnant individuals ≥ 12 years, weighing ≥ 40 kg, with positive SARS-CoV-2 test (within 10 days). Those receiving care outside YNHHS or receiving other SARS-CoV-2 treatment were excluded. We assessed demographics, medical history, and Monoclonal Antibody Screening Score (MASS). The primary composite clinical outcome assessed included emergency department (ED) visit < 24 h, hospitalization, intensive care unit (ICU) admission, and/or death within 29 days of sotrovimab. Secondarily, adverse feto-maternal outcomes and events for neonates were assessed at birth or through the end of the study period, which was 8/15/22. Results Among 22 subjects, median age was 32 years and body mass index was 27 kg/m2. 63% were Caucasian, 9% Hispanic, 14% African-American, and 9% Asian. 9% had diabetes and sickle cell disease. 5% had well-controlled HIV. 18%, 46%, and 36% received sotrovimab in trimester 1, 2, and 3, respectively. No infusion/allergic reactions occurred. MASS values were < 4. Only 12/22 (55%) received complete primary vaccination (46% mRNA-1273; 46% BNT162b2; 8% JNJ-78,436,735); none received a booster. Conclusions Pregnant COVID-19 patients receiving sotrovimab at our center tolerated it well with good clinical outcomes. Pregnancy and neonatal complications did not appear sotrovimab-related. Though a limited sample, our data helps elucidate the safety and tolerability of sotrovimab in pregnant women.

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“…A large retrospective, propensity score-matched cohort study from the UPMC Health System insurance (Pittsburgh, PA, USA) from April 2021 to January 2022 included 994 women with a median gestational age of 179 days and mild to moderate COVID-19; 552 unvaccinated women received mAbs, and most were treated with sotrovimab; others received bamlanivimab and etesevimab or casirivimab and imdevimab [89]. Adverse events were rare, demonstrated in 1.4 % of women.…”

Section: Treatment With Monoclonal Antibodiesmentioning

confidence: 99%

COVID-19, Pregnancy, and Diabetes Mellitus

Kleinwechter,

Weber,

Liedtke

et al. 2023

Z Geburtshilfe Neonatol

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During the severe acute respiratory distress virus coronavirus type 2 (SARS-CoV-2) pandemic, many women were infected during their pregnancies. The SARS-CoV-2-induced coronavirus disease 19 (COVID-19) has an impact on maternal health and pregnancy outcomes; peripartum and perinatal morbidity and mortality are increased. Pregnancy is considered a risk factor for severe COVID-19 course. Additional risk factors during pregnancy are diabetes mellitus, gestational diabetes mellitus (GDM), and obesity. Systemic inflammation can lead to severe metabolic dysregulation with ketoacidosis. The endocrine pancreas is a target organ for SARS-CoV-2 and the fetal risk depends on inflammation of the placenta. Up to now there is no evidence that SARS-CoV-2 infection during pregnancy leads to permanent diabetes in mothers or their offspring via triggering autoimmunity or beta cell destruction. The frequently observed increased prevalence of GDM compared to the years before the pandemic is most likely due to changed lifestyle during lockdown. Furthermore, severe COVID-19 may be associated with the development of GDM due to worsening of glucose tolerance. Vaccination with a mRNA vaccine is safe and highly effective to prevent infection and to reduce hospitalization. Registries support offering evidence-based recommendations on vaccination for pregnant women. Even with the current omicron virus variant, there are increased risks for symptomatic and unvaccinated pregnant women.

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Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy

Cited by 11 publications

References 30 publications

Use of Monoclonal Antibodies in Pregnant Women Infected by COVID-19: A Case Series

Use of Monoclonal Antibodies in Pregnant Women Infected by COVID-19: A Case Series

Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO)

COVID-19, Pregnancy, and Diabetes Mellitus

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