Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy
Erin K. McCreary, Lara Lemon, Christina Megli, Amber Oakes, Christopher Seymour, UPMC Magee Monoclonal Antibody Treatment Group, Rich Beigi, Maribeth McLaughlin, Hyagriv N. Simhan, Harold C. Wiesenfeld, Scarlet Lau, Michael Haley, Sandy Trizzino, Ashley Steiner, Lauren Wiser, Michelle Adam, Tina Borneman, David T. Huang, Richard J. Wadas, Russell Meyers, J Ryan Bariola, Mark Schmidhofer, Graham M. Snyder, Donald M. Yealy, Derek C. Angus, Tami Minnier, Judith A. Shovel, Debbie Albin, Oscar C. Marroquin, Kevin Collins, Adam C. King, Kevin E. Kip, Mary Kay Wisniewski, Colleen Sullivan, Meredith Axe, William Garrard, Stephanie K. Montgomery, Ghady Haidar, Paula L. Kip, Rachel L. Zapf, Sharen Ziska, Jessica Shirley, Rebecca Medva
Abstract
BACKGROUND: Monoclonal 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 with no mAb treatment. OBJECTIVE: To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19-related hospital admission or emergency department (ED) visit, COVID-19-associated delivery, or mortality. DESIGN: Retrospective, propensity score-matched, cohort study. SETTING: UPMC Health System from 30 April 2021 to 21 January 2022. PARTICIPANTS: Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test). INTERVENTION: Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment. MEASUREMENTS: Drug-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. RESULTS: = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19-associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score-matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19-related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, 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%). LIMITATIONS: Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients. CONCLUSION: In 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. There was no difference in 28-day COVID-19-associated outcomes and non-COVID-19-related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score-matched cohort. PRIMARY FUNDING SOURCE: No funding was received for this study.