Safety and efficacy of pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in patients with glomerular diseases who received rituximab

Background Patients on B-cell-depleting agents may have a suboptimal response to vaccination, placing them at a higher risk of contracting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or suffering from a more severe prognosis. Indeed, available data on pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in subjects with glomerular diseases (GDs) who received rituximab are limited. Methods We conducted a prospective study analysing the safety and efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis in patients with GDs who received rituximab in the previous 12 months. The rates of symptomatic infections and hospitalizations were compared with those for patients with GD treated with rituximab who refused to receive tixagevimab/cilgavimab. Results Tixagevimab/cilgavimab was administered to 22 patients (12 females, mean age 58.4 +/- 19.6 years) with GD diagnoses including membranous nephropathy, lupus nephritis, anti-neutrophil cytoplasmic antibody-associated vasculitis and focal segmental glomerulosclerosis. No patient treated with tixagevimab/cilgavimab experienced symptomatic infection with SARS-CoV-2 during the follow-up (mean observation time of follow-up was 112 +/- 23 days), while 11 of 28 controls (39.3%) reported a symptomatic infection (P = .0001), requiring hospitalization in 2 cases. Reported adverse events were mild, namely self-limiting headache [], discomfort at the injection site [], flu-like symptoms/myalgia [] and fever []. No serious adverse events (e.g. cardiac events, anaphylaxis) were reported. Conclusion Pre-exposure prophylaxis with tixagevimab/cilgavimab seems safe and lowered the risk of symptomatic SARS-CoV-2 infection by approximate to 40% in vaccinated subjects with GD who received anti-CD20 therapy. Possible applications in the subset of patients who need immunosuppressive therapy, especially with rituximab, in a pandemic setting might be envisaged.Lay Summary To date, the main defence against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is vaccination. Nonetheless, some patients may have a suboptimal response to it, placing them at a higher risk of contracting SARS-CoV-2 or suffering from a more severe prognosis. An example is represented by patients undertaking B-cell-depleting drugs, such as rituximab. In this selected population, the use of the monoclonal antibodies tixagevimab and cilgavimab (Evusheld) could be considered. In our study, we observed that pre-exposure prophylaxis with Evusheld in vaccinated patients with glomerular diseases who received rituximab seems to be safe and reduces the risk of symptomatic SARS-CoV-2 infection.