Tixagevimab-Cilgavimab Rollout on Common Variable Immunodeficient Patients: Early Lessons from an Academic Allergy and Immunology Clinic

ABSTRACT

Rationale Tixagevimab-cilgavimab is a combination of two monoclonal antibodies against SARS-CoV-2. In December 2021, the FDA issued emergency use authorization for intramuscular injection of tixagevimab-cilgavimab for prophylaxis against SARS-CoV-2 in immunocompromised patients. Shortly thereafter, our clinic distributed tixagevimab-cilgavimab to patients with Common Variable Immunodeficiency (CVID). To our knowledge, no prior study has looked at effects of this monoclonal antibody combination on CVID patients. Methods: 47 patients with CVID were offered tixagevimab-cilgavimab. 23 chose to receive prophylaxis. Comparative outcomes of treatment and non-treatment groups examined occurrence of SARS-CoV-2 infection, severity of SARS-CoV-2 infection, and other non-SARS-CoV-2 infections. Results: 70% were female;mean age 49. 23 patients received tixagevimab-cilgavimab and 24 did not receive prophylaxis. In the tixagevimab-cilgavimab group, all were vaccinated for SARS-CoV-2 and 22 were receiving immunoglobulin replacement. In the cohort that did not receive prophylaxis, 21 were vaccinated, and all received immunoglobulin replacement. In the prophylaxis group one patient was infected with SARS-CoV-2, no patients required emergency care, and 7 patients had non- SARS-CoV-2 infection. In the group that did not receive prophylaxis 2 patients tested positive for SARS-CoV-2, one patient required emergency care due to SARS-CoV-2 disease severity, and four patients had a non-SARS-CoV-2 infection. None of the results showed statistical significance. Conclusions: Although there is preliminary evidence that tixagevimab-cilgavimab can be protective against SARS-CoV-2 in immunocompromised individuals, our data suggests that this benefit may be blunted in CVID patients on immunoglobulin replacement. The additional benefit of tixagevimab-cilgavimab in immunocompromised patients already receiving replacement therapy requires further exploration.