The following is the summary of “Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy” published in the December 2022 issue of Internal medicine by McCreary, et al.
High-risk outpatients with mild to moderate COVID-19 who get monoclonal antibody (mAb) treatment have a reduced risk of hospitalization and mortality. However, no trials have compared the safety and efficacy of mAb therapy with placebo in pregnant women. The study’s goal was to compare the rates of drug-related adverse events and obstetric-related safety outcomes between pregnant women who received mAb treatment versus those who did not, as well as to examine the correlation between mAb treatment and a composite of hospitalization, ED visit, delivery, and death within 28 days of a COVID-19 diagnosis. Cohort research looks at past data and pairs individuals based on their propensity scores. From April 30, 2021, until January 21, 2022, you’ll be at UPMC’s Health System. SARS-CoV-2 positive pregnant women or women with a history of SARS-CoV-2 infection (aged 12 or older) (polymerase chain reaction or antigen test).
Compared to no mAb treatment, the outcomes of interventions including Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab were favorable. Drug-related adverse events, obstetric-related safety outcomes among women who gave birth, and a risk-adjusted composite of hospitalization or ED visit, delivery, or death within 28 days of contracting COVID-19 were all included as outcome measures. About 552 out of 944 pregnant women (median age [IQR], 30 [26 to 33]; White (79.5%; n = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]) were given mAb therapy (58 percent). The most common treatment was sotrovimab (69%), and the median gestational age at diagnosis or treatment for COVID-19 was 179 days (IQR, 123 to 227). About 62% (392) immunization rates were among those whose vaccination status was known. Only 8 women, or 1.4%, experienced a drug-related adverse event, and there were no significant differences in obstetric-related outcomes among the remaining 778 women. With regard to the composite 28-day COVID-19-associated outcome, the risk ratio for mAb therapy was 0.71 (95% CI, 0.37 to 1.4) in the overall population. 0.61 (95% CI: 0.34 to 1.1) was the risk ratio after adjusting for propensity scores. Patients treated with mAbs had a 100% survival rate, while the control group had a 100% mortality rate (1 death). The propensity score-matched rates were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%), but there was no difference in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7).
Drug-related adverse events were reported by patients and healthcare providers, which may lead to an underrepresentation of the true incidence. It was not possible to determine the severity of symptoms for untreated patients at the time of SARS-CoV-2 testing. The incidence of serious side events was low and generally mild following mAb treatment for pregnant women with mild to moderate COVID-19. When comparing those who gave birth after receiving mAb treatment with those who did not, there was no discernible difference in obstetric-related safety outcomes. When comparing mAb treatment to no mAb treatment in a group with a similar propensity score, there was no change in 28-day COVID-19-associated outcomes or hospital admissions for reasons other than COVID-19.