Data source
This is an observational, cross-sectional study designed by the Allergy Department of Castellon’s University General Hospital, Spain. Subjects recruited were pediatric patients with severe asthma in treatment with MAB, pertaining to the Pediatric Allergy Department in our hospital. Inclusion criteria: patients with severe asthma, in treatment with MAB (omalizumab, mepolizumab, benralizumab, reslizumab or dupilumab), for 6 months or more and with a positive complementary study for asthma diagnosis (spirometry with positive bronchial dilatation, or positive methacholine test). Exclusion criteria: patients who had recently started biological treatment (˂ 6 months), or patients who did not compliment treatment correctly. Analysis dates went from 1º March to 31º July 2020.
To answer the objectives proposed, a questionnaire was developed with a total of 19 questions (Table 1) divided in 3 blocks. Block one: (questions 1 to 4) patients were asked about their lifestyle before the pandemic. Block two: (questions 5 to 9) referred to COVID-19 symptoms and possible exposition to the disease. Block Three: (questions 10 to 19) analyzed patients’ behavior, asthma control and treatment during the pandemic.
When analyzing their daily activity before the pandemic (question 1), an active level of activity was defined as going out 7 days a week (school, sport activities, social meetings, shopping, etc.); a normal level 5 days a week, a moderate level less than 5 days a week, and a low level of activity less than 2 days a week. When referring to therapeutic adherence to base treatment (question 10), Test of Adherence to Inhalers (TAI – 10 items) [6] was used. A result of 50 meant good adherence, between 46-49 meant intermedia adherence, and 45 or below, meant bad adherence. Subsequently, to analyze patients’ asthma control (question 15), the Asthma control test (ACT) [7] was used. A result of 20 or more meant good asthma control, meanwhile, 19 or less, meant poor asthma control. Questionnaires were filled out with a face-to-face interview with prior authorization from their parents. Approval from the ethics committee was obtained.
Clinical data was also collected for each patient (Table 2), using the hospital‘s clinical network. Clinical values were chosen based on risk and protective factors described for coronavirus disease. [8,9] Data registered included, sex, age, type of asthma, inhaled corticosteroid doses, and comorbidities. Significant clinical values for asthma syndrome were recorded: FEV1, association of nasal polyps, Samter’s Triad, Allergic bronchopulmonary Aspergillosis (ABPA), and the need of medical attention or hospitalization in the last year, due to uncontrolled asthma.
Finally, in order to study COVID-19 prevalence in our patients, serological tests were performed at the hospital’s laboratory, to all patients, by using total SARS-Cov-2 antibody test by immunochromatography (Wondfo®, Guangzhou Wondfo Biotech Co., Ltd. P.R. China), being its sensitivity (86.43%) and its specificity (99.57%).