Real-world Effect of Monoclonal Antibody Treatment in COVID-19 Patients in a Diverse Population in the United States

Abstract

Background: Monoclonal antibodies (mAbs) against SARS-CoV-2 are a promising treatment for limiting the progression of COVID-19 and decreasing strain on hospitals. Their use, however, remains limited, particularly in disadvantaged populations. Methods: Electronic health records were reviewed from SARS-CoV-2 patients at a single medical center in the United States that initiated mAb infusions in January 2021 with the support of the U.S. Department of Health and Human Services' National Disaster Medical System. Patients who received mAbs were compared to untreated patients from the time period before mAb availability who met eligibility criteria for mAb treatment. We used logistic regression to measure the effect of mAb treatment on the risk of hospitalization or emergency department (E.D.) visit within 30 days of laboratory-confirmed COVID-19. Results: Of 598 COVID-19 patients, 270 (45%) received bamlanivimab and 328 (55%) were untreated. Two hundred and thirty-one patients (39%) were Hispanic. Among treated patients, 5/270 (1.9%) presented to the E.D. or required hospitalization within 30 days of a positive SARS-CoV-2 test, compared to 39/328 (12%) untreated patients (p<0.001). After adjusting for age, gender, and comorbidities, the risk of E.D. visit or hospitalization was 82% lower in mAb-treated patients compared to untreated patients (95% confidence interval [CI]: 66%-94%). Conclusions: In this diverse, real-world COVID-19 patient population, mAb treatment significantly decreased the risk of subsequent E.D. visit or hospitalization. Broader treatment with mAbs, including in disadvantaged patient populations, can decrease the burden on hospitals and should be facilitated in all populations in the United States to ensure health equity.

Emulation of a target trial from observational data to compare effectiveness of Casirivimab/Imdevimab and Bamlanivimab/Etesevimab for early treatment of non-hospitalized patients with COVID-19

“…In June 2021 21 , AIFA expanded use of mAbs including all patients with one of the following: 65 years and older, BMI >30, any chronic renal impairment (including subjects undergoing peritoneal dialysis or hemodialysis), uncontrolled or complicated diabetes mellitus, any immunocompromising condition, cardio-cerebrovascular diseases (including hypertension with concomitant organ damage), COPD or other chronic respiratory diseases, chronic liver disease, hemoglobinopathies, neurodevelopmental and neurodegenerative disease. Comorbidity burden was assessed using Monoclonal Antibodies Screening Score (MASS [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] ) that assigned points, as follows: age ≥65 (2 points), BMI ≥35 (1 point), diabetes mellitus (2 points), chronic kidney disease (3 points), cardiovascular disease in a patient ≥55 years (2 points), chronic respiratory disease in a patient ≥55 years (2 points), hypertension in a patient ≥55 years (1 point), and immunocompromised status (3 points). All consecutive adult patient (age>18) who provided a written informed consent were included in study population.…”