ABSTRACT
Background and ImportanceCilgavimab/tixagevimab are recombinant human IgG1ĸ monoclonal antibodies, which are indicated for COVID-19 pre-exposure prophylaxis in adults and adolescents ≥12 years of age weighing ≥40 kg.Aim and ObjectivesTo assess patients who are potential candidates for treatment with cilgavimab/tixagevimab in a tertiary care hospital and to describe the search strategy.Material and MethodsIn Spain, potential candidates for treatment with cilgavimab/tixagevimab are people with a high degree of immunosuppression (due to pathology or treatment) who do not respond adequately to vaccination. The Spanish Agency of Medicines and Health Products establishes the conditions for patients who are candidates for treatment with cilgavimab/tixagevimab1 . A search for patients was carried out, prioritising the following criteria: haematological patients on treatment with rituximab during the last 9 months, patients with solid organ transplant, patients with multiple sclerosis on treatment with ocrelizumab/rituximab, and patients with recent infection by COVID-19 who belong to any risk group. All of them underwent serology, including in the study those with negative serology (anti-anati-S antibodies < 260 BAU/ml). Those patients were scheduled for cilgavimab/tixagevimab administration.Results112 patients (38 = haematological patients on rituximab treatment, 50 = multiple sclerosis patients on rituximab/ocrelizumab treatment and 24 = kidney transplantation) were enrolled. 72 patients were included, 38 women (52.8%), median age 59.5 years old (27-77). The cause of exclusion was positive serology in all cases. 64 patients (88.9%) were on treatment with biologic immunomodulators (35 haematologic patients treated with rituximab <9 months, 27 patients with multiple sclerosis on treatment with rituximab/ocrelizumab/interferon beta-1A and 1 patient on treatment with adalimumab) and the rest were kidney transplant patients. Cilgavimab/tixagevimab was administered to 62 patients (86.1%), 7 patients with unknown reasons, 2 patients had COVID-19 infection and 1 patient had to be excluded for deep vein thrombosis due to the development of symptoms at the time of the appointment.Conclusion and RelevanceMore than half of the patients enrolled did not have an adequate response to COVID-19 vaccination. The search strategy was a good tool for administering pre-exposure prophylaxis of COVID-19 to these more vulnerable patients. Further studies are needed to evaluate the effectiveness of the treatment.References and/or Acknowledgements1. https://www.aemps.gob.es/la-aemps/ultima-informacion-de-la-aemps-acerca-del-covid%E2%80%9119/prevencion-frente-a-la-covid-19/personas-candidatas-a-recibir-evusheld-en-espana/#:~:text=En%20Espa%C3%B1a%2C%20son%20potenciales%20candidatas,responden%20adecuadamente%20a%20la%20vacunaci%C3%B3n.Conflict of InterestNo conflict of interest
ABSTRACT
Background and ImportanceCilgavimab/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 ObjectivesTo analyse the effectiveness and safety of cilgavimab/tixagevimab in a tertiary care hospital.Material and MethodsDescriptive, 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.Results43 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 RelevanceThe 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.References and/or AcknowledgementsConflict of InterestNo conflict of interest