Data source
This is an observational, cross-sectional study designed by the Allergy Department of Castellon’s University General Hospital, Spain. Subjects recruited were patients with severe asthma in treatment with MAB, pertaining to the Departments of Allergy and/or Pneumology in our hospital (108 patients). A list of all patients was obtained by using the data base available in each department. Inclusion criteria: patients with severe asthma, in treatment with any of the MAB, approved for severe asthma treatment (omalizumab, mepolizumab, benralizumab or reslizumab), during 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 had discontinued treatment by self-decision. The time span of analysis dates from 1º March to 30º May 2020, corresponding to the months with most incidence of the disease in Spain.
In order to answer the principal objective, a questionnaire was developed with a total of 19 questions (Table 1) divided in 3 blocks. Block one corresponds to questions 1 to 4, where patients were asked about COVID-19 symptoms, COVID-19 RT-PCR and serological tests results. Block two: questions 5 to 11 made reference to asthma control and treatment during the pandemic. Block Three: questions 12 to 19 analyzed possible exposition to the disease, and their lifestyle before the pandemic.
When referring to therapeutic adherence to base treatment (questions 5 and 10), Test of Adherence to Inhalers (TAI – 10 items) [10] was used. A result of 50 meant good adherence, between 46-49 meant intermedia adherence, and 45 or below, meant bad adherence. Subsequently, in order to analyze patients’ asthma control, the Asthma control test (ACT) [11] was used. A result of 20 or more meant good asthma control, meanwhile, 19 or less, meant poor asthma control. When analyzing their daily activity before the pandemic (question 15), an active level of activity, was defined as, going out 7 days a week (for work, 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. Questionnaires were completed either face-to-face or by telephone. Before filling in the questionnaire, oral consent was requested to each patient. Approval from the ethics committee was obtained.
Clinical data values analyzed for each patient (Table 2), were collected using the hospital‘s clinical network. Clinical values were chosen based on risk and protective factors described for coronavirus disease [12, 13]. Data registered included, sex, age, type of asthma, inhaled corticosteroid doses, oral corticosteroid treatment, 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. Once each variable was collected and analyzed, serological tests were performed at the hospital’s laboratory, to patients who have had suggestive COVID-19 symptoms, by using total SARS-Cov-2 antibody test by immunochromatography (Wondfo®, Guangzhou Wondfo Biotech Co., Ltd. P.R. China). During the months of June and July, blood tests were carried out to patients, the day they came for their biological treatment administration.