Monoclonal antibody treatment for COVID-19 stands safe in pregnancy: Study

Pennsylvania : A single-center study published in Annals of Internal Medicine found that monoclonal antibody therapy for COVID-19 was safe to use during pregnancy but was only marginally effective.

"This is one of the largest datasets documenting safety and efficacy of monoclonal antibodies for COVID-19 treatment in pregnancy," said Erin McCreary, PharmD, of the University of Pittsburgh Medical Center.

Despite mixed efficacy findings, she emphasized that monoclonal antibody therapy may nonetheless be the best option depending on a patient's unique risk profile for developing a serious illness.

Pregnancy was added as a risk factor for severe COVID-19 in May 2021 updates to emergency use authorizations for monoclonal antibodies. McCreary's team noted that few studies have looked into the efficacy and safety of these treatments for pregnant patients.

To assess the effectiveness of monoclonal antibody treatment in pregnant patients who tested positive for SARS-CoV-2, researchers conducted the retrospective cohort analysis. Between April 2021 and January 2022, University of Pittsburgh Medical Center provided care for all trial participants.

All patients receiving monoclonal antibody therapy prior to mid-December 2021 received a medication such as bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab. Every patient treated with this variation received IV sotrovimab (mid-December 2021 to January 2022). According to the authors, patients underwent treatment in any outpatient infusion center, urgent care center, or obstetric triage area, and both the treated and untreated cohorts underwent a 28-day follow-up period.

Using drug-related adverse events (AEs) recorded by healthcare professionals or patients at each treatment location as well as obstetric results, the team assessed the safety of monoclonal antibodies. The likelihood of receiving therapy was modeled using multivariate logistic regression, which produced propensity scores. This model included factors like age, race, vaccination status, gestational age, insurance type, medical comorbidities, and others.

58% of 944 pregnant patients, with a median age of 30, were treated with monoclonal antibodies. At the time of the COVID-19 diagnosis, the mean gestational age was 179 days, or more than 25 weeks of pregnancy. 62% of patients with known vaccination status had received all recommended doses.

Conclusive points of the research:

• There were 8 instances of drug-related adverse events (n = 1, or 1.4%), but there were no variations in any obstetric-related outcomes among the 778 women who gave birth.
• The risk ratio for mAb therapy of the composite 28-day COVID-19-associated outcome in the entire population was 0.71 (95% CI, 0.37 to 1.4).
• The risk ratio for propensity score matching was 0.61 (95% CI, 0.34 to 1.1).
• there was only one fatality among the control patients who weren't receiving mAb treatment.
• Although there was no difference in the propensity score-matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%), there were more non-COVID-19-related hospital admissions in the mAb-treated individuals in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7).

According to McCreary, the use of monoclonal antibody therapy in pregnant patients is dubious if new variations continue to show resistance to them. These treatments are a good choice for individuals who are pregnant if antibodies that neutralize current variations are still accessible, she added.

REFERENCE

McCreary E, et al "Monoclonal antibodies for treatment of SARS-CoV-2 infection during pregnancy" Ann Intern Med 2022; DOI: 10.7326/M22-1329.