Treatment with anti-SARS-CoV-2 monoclonal antibodies in pregnant and postpartum women: first experiences in Florence, Italy

Manciulli, Tommaso; Modi, Giulia; Campolmi, Irene; Borchi, Beatrice; Trotta, Michele; Spinicci, Michele; Lagi, Filippo; Bartoloni, Alessandro; Zammarchi, Lorenzo

doi:10.1007/s15010-022-01777-z

Cited by 8 publications

(4 citation statements)

References 33 publications

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“…We identified 53 articles, 28 of which were assessed with respect to their eligibility for inclusion and 17 studies ultimately included in the systematic review ( Table 1 , Figure 1 ) [ 30 , 32 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 ]. Eight studies came from the United States of America (USA), four from Europe, three from Japan and the other two studies were from the United Arab Emirates (UAE).…”

Section: Resultsmentioning

confidence: 99%

Do Anti-SARS-CoV-2 Monoclonal Antibodies Have an Impact on Pregnancy Outcome? A Systematic Review and Meta-Analysis

et al. 2023

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Monoclonal antibodies (mAbs) have been used as a rescue strategy for pregnant women affected by COVID-19. To explore its impact on maternal-fetal health, we included all observational studies reporting maternal, fetal, delivery and neonatal outcomes in women who underwent mAbs infusion for COVID-19. Primary outcome was the percentage of preterm delivery. We used meta-analyses of proportions to combine data for maternal, fetal, delivery and neonatal outcome of women treated with mAbs for COVID-19 and reported pooled proportions and their 95% confidence intervals (CIs) for categorical variables or mean difference (MD) with their 95% confidence intervals for continuous variables. Preterm birth was observed in 22.8% of cases (95% CI 12.9–34.3). Fetal distress was reported in 4.2% (95% CI 1.6–8.2). Gestational hypertension and pre-eclampsia were observed in 3.0% (95% CI 0.8–6.8) and 3.4% (95% CI 0.8–7.5) of cases, respectively. Fetal growth restriction was observed in 3.2% of fetuses (95% CI 0.8–7.0). Secondary prophylaxis with mAbs is currently considered the best treatment option for people with mild to moderate COVID-19 disease. More attention should be paid to infants born from mothers who were treated with mAbs, for the risk of immunosuppression.

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Section: Resultsmentioning

confidence: 99%

Do Anti-SARS-CoV-2 Monoclonal Antibodies Have an Impact on Pregnancy Outcome? A Systematic Review and Meta-Analysis

et al. 2023

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“…However, for preventive purposes, pregnant women have been included among the risk categories for major consequences of a related COVID-19 infection [ 1 , 2 , 3 , 4 , 5 , 6 ]. Furthermore, pregnant women have been excluded from clinical pharmaceutical trials of new drugs to be used against the virus, resulting in poor documentation of the complications and consequences of infection during pregnancy [ 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. Nonetheless, the results of some studies showed that COVID-19 infection during pregnancy was associated with a greater probability of maternal, fetal, and neonatal adverse events [ 14 , 15 , 16 ], as more cases of preeclampsia, hospitalization in intensive care, preterm birth, and neonatal mortality were recorded compared to pregnant women not affected by the virus [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

“…Microorganisms 2023,11, 1953. https://doi.org/10.3390/microorganisms11081953 https://www.mdpi.com/journal/microorganisms…”

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confidence: 99%

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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“…[3][4][5][6] Yet, no studies evaluate the effectiveness of mAbs targeting SARS-CoV-2 among pregnant persons, data are limited on the safety of mAbs in pregnancy, and immunoglobulin-based therapy remains controversial. [7][8][9][10][11][12][13] The purpose of this study is to estimate the rate of drug-related adverse events from mAb treatment among a cohort of pregnant persons with SARS-CoV-2 infection, the rate of obstetric-associated safety outcomes among all persons who delivered, and the risk-adjusted association between mAb treatment and composite 28-day COVID-19-related hospital admission or emergency department (ED) visit, COVID-19-associated delivery, or mortality compared to no mAb treatment.…”

Section: Introductionmentioning

confidence: 99%

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

McCreary

Lemon

Megli

et al. 2022

Preprint

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IMPORTANCEMonoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared to no mAb treatment.OBJECTIVETo determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared to no mAb treatment, and the association between mAb treatment and a composite of 28-day COVID-19-related hospital admission or emergency department visit, COVID-19-associated delivery, or mortality.DESIGN, SETTING, PARTICIPANTSPropensity-score matched cohort study of persons aged 12 years of age or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test) in the UPMC health system from April 30, 2021 to January 21, 2022.EXPOSURESBamalanivmab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared to no mAb treatment.MAIN OUTCOMES AND MEASURESDrug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19-related hospital admission or ED visit, COVID-19-associated delivery, or mortality.RESULTSAmong 944 pregnant persons (median [IQR] age 30 [26, 33] years, White (79.5%, N=750), median [IQR] Charlson Comorbidity Index Score 0 (0,0)), 552 persons received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR: 123, 227), and most persons received sotrovimab (69%, N=382). Of those with known vaccination status, 178 (62%) were fully vaccinated. Drug-related adverse events were uncommon (N=8, 1.4%), and there were no differences in any obstetric-associated outcome among 276 persons who delivered. After propensity score matching, the frequency of the composite 28-day COVID-19-associated outcome was 4.0 per 100 persons (95% CI 1.9, 6.2) in mAb-treated compared to 3.7 per 100 persons (95% CI 1.7, 5.8) in non-treated controls (risk difference = 0.31 per 100 persons [95% CI -2.6, 3.3). There were no deaths among mAb-treated patients compared to 1 death in the non-treated controls (p = 0.24). There were more non-COVID-19-related hospital admissions in the mAb-treated persons (risk difference 2.8 per 100 persons (95% CI 1.1, 4.5)).CONCLUSIONS AND RELEVANCEIn pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. MAb treatment was associated with similar 28-day COVID-19-associated outcomes and more non-COVID-19-related hospital admissions compared to no mAb treatment.Key PointsQUESTIONAmong pregnant persons with COVID-19, is monoclonal antibody (mAb) treatment associated with drug-related adverse events, similar frequency of obstetric-associated safety outcomes, and improved COVID-19-related clinical outcomes compared to no mAb treatment?FINDINGSIn 944 pregnant persons with COVID-19, drug-related adverse events were mild and infrequent. Obstetric-associated safety outcomes were similar between mAb treatment and no treatment. There was no evidence of difference in risk of COVID-19-related hospital admission, COVID-19-associated delivery, or mortality between mAb treatment and no mAb treatment.MEANINGIn pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were uncommon, and there was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment. MAb treatment was associated with similar 28-day risk of a COVID-19-associated outcome and more non-COVID-19-related hospital admissions compared to no mAb treatment.

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Treatment with anti-SARS-CoV-2 monoclonal antibodies in pregnant and postpartum women: first experiences in Florence, Italy

Cited by 8 publications

References 33 publications

Do Anti-SARS-CoV-2 Monoclonal Antibodies Have an Impact on Pregnancy Outcome? A Systematic Review and Meta-Analysis

Do Anti-SARS-CoV-2 Monoclonal Antibodies Have an Impact on Pregnancy Outcome? A Systematic Review and Meta-Analysis

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

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

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