Article Text
Abstract
Background and Importance Cilgavimab/tixagevimab are two recombinant human IgG1ĸ monoclonal antibodies indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents ≥12 years old weighing ≥40 kg. In Spain, potential candidates are people with high degree of immunosuppression (due to pathology or treatment), who do not respond adequately to vaccination (anti-anati-S antibodies <260 BAU/ml).
Aim and Objectives To analyse the effectiveness and safety of cilgavimab/tixagevimab in a tertiary care hospital.
Material and Methods Descriptive, observational, retrospective study. Patients who received cilgavimab/tixagevimab from May-2022 to August-2022 were included. Variables collected: age, sex, risk condition and COVID-19 infection. The risk conditions, according to criteria of the Spanish Agency of Medicines and Health Products were: 1) haematopoietic progenitor transplant recipient or CART-T, in immunosuppressive treatment or with graft-versus-host disease; 2) solid organ transplant recipients; 3) primary combined and B-cell immunodeficiencies with absence of response to vaccination-COVID-19; 4) immunosuppressive treatment with biologic immunomodulators (anti-CD20, abatacept, belimumab or mycophenolate, mainly); 5) solid organ cancer under treatment with cytotoxic chemotherapy or treatments that carry a high risk of severe COVID-19 progression; 6) people at very-high-risk of severe COVID-19 who are contraindicated for COVID-19-vaccination. The primary endpoint was COVID-19-infection after cilgavimab/tixagevimab administration. Safety was analysed by incidence of adverse reactions.
Results 43 patients were included. 23 men (53.5%), median age=64 years old (27-77). 36 patients (83.7%) were in risk group 4 (26 patients treated with rituximab, 6 patients with ocrelizumab, 1 patient with adalimumab and 1 patient with interferon beta-1A) and 7 patients were in risk group 2 (all kidney transplant). 4 patients (9.3%) had COVID-19 infection after treatment with cilgavimab/tixagevimab (3 were in group 4 and 1 was in group 2). The median number of days to COVID-19-infection occurrence in these patients was 25 days. 1 patient had adverse reactions after treatment (tachycardia, general malaise, hematoma, headache, nausea and diffuse abdominal pain).
Conclusion and Relevance The treatment was effective in the majority of patients in our hospital. This supports the use of the drug as prophylaxis to prevent COVID-19 in people who do not respond sufficiently to vaccination. The treatment was well tolerated, presenting low incidence of adverse reactions. Longer term studies should be performed.
Conflict of Interest No conflict of interest