ABSTRACT
Background: In first pandemic wave, SARS-CoV2 infection was hypothesized to be more frequent and severe in asthmatic patients with reduced anti-viral immune response and typical disease flares during viral respiratory infections. Despite this, the studies performed to date have not confirmed these data. The purpose of our research is to evaluate the prevalence and clinical trend in patients with bronchial asthma among hospitalized for COVID-19 in North-West Italy. Method(s): In our multicentre retrospective study, we enrolled all patients hospitalized for COVID-19 from February to July 2020 at four leading hospitals: City of Health and Science of Turin (Molinette-unit), Umberto I Hospital (Turin), Umberto Parini Hospital (Aosta) and Santa Croce and Carle Hospital (Cuneo). We inclueded all patients with SARS-CoV- 2 positive nasopharyngeal swab and/or serology and/or clinical features highly suggestive of SARS-CoV- 2 infection and a hospital stay for COVID-19 of more than 48 hours. We excluded patients with exacerbation of disease not related to SARS-CoV- 2 and fewer than 48 hours of hospital stay;for each patient were collected demographic and clinical data before and during admission. Result(s): We evalueted 1016 patients: 110 (10.8%) had obstructive airway disease [71 COPD (6.9%) and 39 bronchial asthma (6.9%)]. The majority of patients with asthma took an inhaled corticosteroids (ICS) with or without Short or Long Acting Beta-Agonists (SABA, LABA) at home (56.4%);only two cases had severe asthma, both in therapy with biologics. A comparison of clinical trend and outcomes in patients with asthma, COPD and no history of obstructive lung disease is in Table 1. Conclusion(s): The prevalence of asthma among hospitalized for COVID-19 was lower than the prevalence data reported in the general population (3.8 vs 6.6% reported by ISTAT), in Piedmont and Val d'Aosta1 (3.8 vs 5.7%) and in recent meta-analysis2 (3.8 vs 8.08%). There were no significant differences between asthmatics and non-asthmatics in gender, age, smoking habits, associated comorbidities, length of hospital stay, development of disease complications, invasive and/or non-invasive ventilation, treatment with hydroxychloroquine, antivirals or biologics or mortality.
ABSTRACT
Background: Mast cell disorders (MCDs) are characterized by the proliferation and accumulation of mast cells in different tissues and their inappropriate release of mediators. Primary MCDs include systemic and cutaneous mastocytosis and monoclonal MC activation syndrome. They manifest with symptoms ranging from rash to anaphylaxis, idiopathic or elicited by heterogeneous factors, including vaccines. Vaccines are useful to prevent severe lung disease and mortality in COVID-19. Early reports of allergic reactions to COVID-19 vaccines emerged;however, their frequency is low. There are limited data on the safety of COVID-19 vaccine for immediate allergic reactions in high-risk patients like those with MCDs. To date, data concerning both the type of premedication and its need in these patients undergoing COVID-19 vaccines are limited. The objective of this study is to evaluate the safety of COVID-19 vaccine in patients with MCDs. Method(s): We included retrospectively patients with primary MCDs, according to WHO criteria, attending the Clinical Immunology and Allergy Unit at AO Mauriziano from June 2000 to December 2021, who underwent COVID-19 vaccination. We reported demographic and clinical data and noted -by phone call -vaccine type, premedication scheme, and contingent reactions. Result(s): We enrolled 44 patients (22 female, 50%), with a median age at diagnosis of 43.4 yrs. 25 patients had ISM, 8 CM, and 11 MMCAS. Median tryptase level was 44.3 ng/ml. 17 patients had history of anaphylaxis, none after vaccination. 37 patients (84.1%) underwent COVID-19 vaccination, 7 refused it. 32 completed the vaccination course, and 5 received two doses only. 25 patients were fully vaccinated with mRNA vaccine. The PEG-allergic one underwent Ad26.COV2.S vaccine, another one had first ChAdOx1, then mRNA-1273. All patients were vaccinated in hospital setting and observed for one hour. Most patients continued the daily antihistamine;9 started it few days before the injection;4 patients underwent vaccination without premedication. None showed anaphylaxis. One patient had immediate flushing;another had a delayed asthma exacerbation. A non-premedicated patient had immediate urticaria at first dose, while he tolerated others with AH The small cohort and the retrospective design limit this study. Nonetheless, the absence of severe hypersensitivity reactions to COVID-19 vaccines in our patients with MCDs, is an important finding. Conclusion(s): Our results confirm that patients with MCDs may be safely vaccinated to COVID-19.
ABSTRACT
Background: Innovative information techniques are increasingly used to perform federated analyses in real-world studies. Whether these techniques are suitable for harmonizing patient data from non-standardized registries and evaluating treatment outcomes needs further evidence. Aim(s): To standardize patient-level registry data from SHARP (Severe Heterogeneous Asthma Registry Patientcentred) and evaluate the effectiveness of mepolizumab on frequent (>=2/yr) exacerbations in patients with severe asthma. Method(s): We standardized data from 5,871 adults with severe asthma in 10 European countries using the OMOP Common Data Model (www.ohdsi.org). Patients who had taken mepolizumab >=1 yr (2016-2021) and had exacerbation data available were included. Changes in odds of >=2 exacerbations/yr were evaluated. Result(s): Of 2,109 patients who initiated mepolizumab 563 met inclusion criteria. Analysis showed a reduction of having >=2 (vs 0-1) annual exacerbations after 1 yr mepolizumab therapy: OR (95%CI) 0.18 (0.13-0.25)[N=369] pre and 0.08 (0.05-0.13)[N=194] during the COVID-19 pandemic (Fig). Conclusion(s): By harmonizing non-standardized, patient-level registry data and applying federated analysis we demonstrated that mepolizumab reduced asthma exacerbations, consistent with current knowledge. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof way. (Figure Presented).