Prophylaxis with tixagevimab/cilgavimab is associated with lower COVID-19 incidence and severity in patients with autoimmune diseases

Abstract

Objective To describe the clinical efficacy of tixagevimab/cilgavimab in pre-exposure prophylaxis in patients at risk of severe COVID-19 and unresponsive to vaccination (anti-SARS-CoV-2 antibodies <260 BAU/mL) in rheumatology. Methods In this multicenter observational study we included patients with autoimmune or inflammatory diseases who received a pre-exposure prophylaxis by tixagevimab/cilgavimab between December 2021 and August 2022. The endpoint was incidence and severity of COVID-19. Results Tixagevimab/cilgavimab was administered to 115 patients, median age 62 years (52-71), with chronic arthritis (n = 53), connective tissue disease (n = 38) or vasculitis (n = 11). Main background immunosuppressants were rituximab (n = 98), corticosteroids (n = 62, median dose 5mg, CI95% 5-8 mg) and methotrexate (n = 48). During a median follow-up of 128 days (93-173), COVID-19 occurred in 23/115patients (20%), Omicron identified for the 8 genotyped patients. During study period, the average weekly incidence was 1071/100.000 inhabitants in Ile-de-France vs. 588/100.000 in our patients. Patients who received a 2-injections regimen had a lower risk of infection than with a single injection (16/49, 33% vs. 5/64, 8%, p = 0.0012). The COVID-19+ patients did not differ from uninfected patients concerning age, comorbidities, underlying rheumatic disease, immunosuppressant. All COVID-19 were non-severe. The tolerance of injections was excellent. Conclusion In a population with autoimmune or inflammatory diseases at risk of severe COVID-19 unresponsive to vaccination, pre-exposure prophylaxis by tixagevimab/cilgavimab was associated with lower incidence of COVID-19 and no severe infection to report.

Tixagevimab/Cilgavimab: Still a Valid Prophylaxis against COVID-19 New Variants?

“…Several studies have reported clinical data about different frail populations such as hematological malignancies, kidney and liver transplant recipients, patients with end-stage renal disease on chronic hemodialysis, autoimmune diseases, and other important comorbidities. Most of these studies observed that in populations unresponsive to vaccination, tixagevimab/cilgavimab pre-exposure prophylaxis was associated with lower incidence of COVID-19 and severe infection [ 15 , 16 , 17 , 18 , 19 ]. These clinical studies were conducted across various timeframes, resulting in patient exposure to diverse variants of concern (VOCs).…”

Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era

“…After a median follow-up of 4.3 months, 23 COVID-19 cases were reported. The authors noted that the incidence of COVID-19 in this population was lower than the COVID-19 incidence in the general population during the study period, whereas patients who received an anamnestic injection had better protection against SARS-CoV-2 infection [ 56 ]. Another small study included patients with glomerular diseases who were under treatment with rituximab.…”