Monoclonal Antibody Therapy for US Veterans With COVID-19

Abstract

T he emergence of the novel virus severe acute respiratory syndrome coronavirus syndrome 2 (SARS-CoV-2) has caused worldwide havoc and devastation not experienced since the 1918 Spanish flu pandemic. Like the pandemic a century ago, effective treatment modalities were not readily available in the beginning of this pandemic. Nevertheless, a global effort to understand the new culprit led to a quick sequencing and exploitation of protein targets for vaccine development, as well as antiviral and other therapeutic agents. The SARS-CoV-2 has spike protein on its surface that helps it attach and enter human cells. 1 Blocking viral entry into human cells can be achieved by targeting this viral spike protein either via a vaccine or via monoclonal antibodies (mAB). Monoclonal antibody therapies have been used in the United States under an emergency use authorization (EUA) by the Federal Drug Administration (FDA). We report our experience using mAB in our institution.We retrospectively reviewed the charts of veterans who received mAB under the FDA's EUA protocol from December 1, 2020, to May 31, 2021, at the Northport Veterans Affairs Medical Center. During this period, 2 mAB were used: casirivimab/ imdevimab (CAR/IMD) by Regeneron Pharmaceuticals Inc, and bamlanivimab (BAM) by Eli Lilly and Company.Thirty-seven veterans (all men) received mABs: 20 CAR/ IMD and 17 BAM. The median age was 72.5 (50-90) years. They were 30 Caucasian and 7 African American veterans. The median body mass index was 29.9 (21.6-53.1). There were 67% who had cough, 31% dyspnea, 33% malaise, 27% diarrhea, 11% anosmia, and 16% nasal congestion. Four patients had fever on presentation (101.2°F to 102.9°F). The median pulse oximetry (SpO 2 ) was 96%. There were 78% who had hypertension, 42% diabetes, 14% chronic obstructive lung disease, 33% coronary artery disease, 11% atrial fibrillation, 6% congestive heart failure, and 6% human immunodeficiency virus. The infusions were well tolerated except for one patient who developed a fever of 104°F after CAR/IMD that responded quickly to antipyretic therapy. Nine patients (7 CAR/IMG and 2 BAM) had to be reevaluated because of worsening symptoms at a later hospital visit. They were treated for coronavirus disease 2019 (COVID-19) with intravenous remdesivir (REM) and steroids. There was no difference in age of the patients who got REM versus those who did not need to receive REM (median, 76 vs 72 years; P = 0.523); there was no difference in body mass index, 30.1 versus 29.8, P = 0.621; diabetes, P = 1.000; hypertension, P = 0.647; chronic obstructive lung disease, P = 1.000; and coronary artery disease, P = 1.000. One patient with non-Hodgkin lymphoma, who required RED along with baricitinib, died. One patient with renal transplant, who required REM/steroids, survived. Three patients had received 1 dose of mRNA COVID-19 vaccine 12, 16, and 16 days before being diagnosed; 1 patient was diagnosed with COVID-19 10 days after second dose of mRNA vaccine and received mAB therapy. None of the vaccine recipients requ...