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
ABSTRACT
Background and ImportanceSotrovimab is indicated in treatment of COVID19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to COVID-severe. The drug is administered according to prioritisation criteria published by the Spanish Agency of Medicines and Health Products (AEMPS)1.Aim and ObjectivesTo analyse the effectiveness of sotrovimab and to know the profile of patients.Material and MethodsObservational, retrospective and descriptive study in a tertiary level hospital. Patients who had received sotrovimab from January/2022-May/2022 were included. Variables: sex, age, mild-moderate/severe disease, vaccination-COVID, risk factors, hospitalisation/death at 29 day. Effectiveness was measured as rate of patients without progression to COVID-severe (defined as hospitalisation/death at 29 days). Variables were collected from digital medical records and in-hospital electronic prescribing.ResultsThirty-seven patients were included, mean age=61 years (21-82), 20 women (54.05%). Twenty-nine patients (78.38%) had mild-moderate COVID. 29 patients (78.38%) had received a complete vaccination regimen (3 doses), 6 patients (16.22%) two doses and 2 patients (5.41%) not vaccinated. Risk factors: 23 hypertension (62.16%), 13 diabetes (35.14%), 5 obesity (13.51%) and 4 asthma (10.81%). All patients were immunosuppressed. 17 patients (45.94%) with 2 risk factors, 9 with 3 risk factors (24.32%), 7 with 1 risk factor (18.91%) and 2 patients (5.40%) with 4 risk factors. According to the AEMPS prioritisation criteria, all belonged to the group of ‘Immunocompromised persons and high-risk conditions, regardless of vaccination status'. The high-risk conditions were: 23 patients (62.16%) had received solid organ transplantation with immunosuppressive treatment, 13 patients (35.14%) had received immunosuppressive treatment with antiCD20 in the previous 6 months (100% rituximab) and 1 patient (2.7%) was receiving active treatment with myelotoxic chemotherapy (inotuzumab) for acute lymphocytic leukaemia. 7 patients (18.9%) were hospitalised/dead at 29 days (3 exitus). All these patients had received rituximab. 30 patients (81.1%) did not progress to severe COVID. During the study period, 6 patients attended the emergency department, without admission.Conclusion and RelevanceMost patients presented good response and tolerance to treatment. This result was independent of previous treatments or risk factors. Previous treatment with anti-CD20 seems to show a tendency to progression to severe COVID. Long-term studies are needed to confirm resultsReferences and/or Acknowledgements1. https://www.aemps.gob.es/medicamentos-de-uso-humano/acceso-a-medicamentos-en-situaciones-especiales/criterios-para-valorar-la-administracion-de-las-nuevas-alternativas-terapeuticas-antivirales-frente-a-la-infeccion-por-sars-cov-2/Conflict of InterestNo conflict of interest