Coronavirus Disease 2019 Vaccine-Induced Flare-Up of Severe Bronchial Asthma Previously Controlled With Dupilumab: A Case Report.

The widespread after-effects of the coronavirus disease 2019 (COVID-19) are still a grave threat worldwide. Among them are adverse reactions to vaccines, including those most observed following Pfizer-BioNTech (BNT162b2) vaccine administration, namely, local reactions at the injection site, fatigue, headache, myalgia, chills, arthralgia, and fever. Patients with asthma particularly present with unique adverse reactions to the BNT162b2 vaccine, notably, an exacerbation in their asthma symptoms as highlighted through the current case report. In this case, a 50-year-old woman had been undergoing treatment for bronchial asthma in the form of inhalation steroids and dupilumab, as well as systemic steroid prednisolone as maintenance therapy. She had mild injection site reactions after her first three COVID-19 vaccinations. She also experienced acute exacerbation requiring hospitalization after the fourth and fifth doses. Her symptoms resolved following steroid therapy. The close association between the timing of vaccinations and the onset of clinical symptoms suggests that the exacerbation episodes were triggered by the vaccine. Therefore, although the BNT162b2 vaccine is safe to administer in patients with bronchial asthma, cases reporting patients sensitized to the BNT162b2 vaccine developing bronchial asthma or experiencing asthma exacerbations should not be neglected. Clinicians should be aware of the possibility of flare-ups induced by repeated COVID-19 vaccinations in such patients.

Organization of immunobiological therapy for severe bronchial asthma in the Sverdlovsk region

BACKGROUND: Biologicals use in severe asthma (SA) is associated with targeted therapy (TT) availability problem. Ensuring the availability of biologicals can be resolved within the territorial compulsory medical insurance program (TCMIP) in day-stay or round-the-clock hospital. AIMS: This study aimed to develop and implement a program for immunobiological therapy (IBT) introduction for SA in Sverdlovsk Region (SR). MATERIALS AND METHODS: Program for introduction of IBT for SA was developed in SR in 2018 to provide patients with expensive biologicals within the TCMIP. Program includes the following: SA prevalence study in SR;practitioners training in differential diagnosis of SA;organization of affordable therapy for patients with SA;registration of patients with SA creation and maintenance;and selection and management of patients with SA in accordance with federal clinical guidelines. RESULT(S): Atopic phenotype in SA was detected in 5%, eosinophilic - in 2.3% of all analyzed cases of asthma (n=216). Practitioners of SR were trained in differential diagnosis of SA. Orders of the Ministry of Health of SR were issued as follows: regulating the procedure for referring patients with SA to IBT, with a list of municipal medical organizations providing IBT in a day-stay or round-the-clock hospital;approving regional registration form of patients with SA requiring biologicals use;ungrouping of clinical and statistical groups of day-stay hospital was depending on INN and dosage of biologicals;and selecting patients with SA for TT and including them in the regional register. Initiating of TT in round-the-clock hospital and continuation therapy in day-stay hospital provides a significant savings in compulsory medical insurance funds. CONCLUSION(S): IBT introduction for SA in SR is carried out within the framework of the developed program. Principle of decentralization brings highly specialized types of medical care closer to patients making it possible to provide routine medical care in "allergology-immunology" profile in the context of restrictions caused by coronavirus disease 2019 pandemic.Copyright © 2020 Pharmarus Print Media All rights reserved.

Role of SARS-CoV-2 in asthma exacerbations

Asthma is one of the most common chronic respiratory diseases in the world and there is great concern about the effect of COVID-19 infection on asthma severity and control. Although the link between asthma and COVID-19 infection remains to be determined, available data indicate that asthma does not seem to be a risk factor for severe COVID-19. This review aims to summarize the updated data about the association between viral infections and asthma exacerbations including COVID infection and management of asthma flare-ups during the COVID pandemic, based on the recommended asthma guidelines.Copyright © 2020 Bilimsel Tip Yayinevi. All rights reserved.

Australia's national asthma research agenda: Priorities for end-users of research

Introduction/Aim: The fifth objective of the 2018 National Asthma Strategy called for the development of a national research agenda. Asthma Australia and partners have completed this project: the National Asthma Research Agenda. Method(s): A national, mixed-method study design adapted from the James Lind Alliance Priority Setting Partnership was adopted. Comprising two discrete phases . A cross-sectional purposive survey of people with asthma, their careers, clinicians and public health professional. The survey findings were analysed thematically. Themes containing questions already answered by high quality research were removed. The project executive team approved the remaining list of themes for phase 2. Three consensus workshops were held comprising health and policy professionals, people with asthma, parents and people from diverse backgrounds to achieve consensus on prioritising and ranking the themes. Workshop participants did this under the guidance of a trained/skilled facilitator. The ranked themes from the workshops were filtered through a computer algorithm, resulting in a top ten list of asthma research priority themes. These themes summarise specific topics and questions and form the National Asthma Research Agenda. Result(s): 593 people completed the survey. Most respondents were female and had asthma. The top ten research priority themes are: Asthma in children Asthma and COVID-19 Asthma care and self-management Diagnosis and medication Managing asthma attacks Causes, prevention and features of asthma Mental health Asthma and ageing Severe asthma Asthma and other health conditions These themes include sub-topics, which reflect the specific inputs of the survey participants. Results were consistent among subgroups. Conclusion(s): The end-user methodology used has been useful in determining what's important to the people who rely on the answers provided by asthma research in Australia. This is a broad research agenda, which highlights the extent of research output that consumers require in order to manage asthma.

Treatable trait guided asthma management: A feasibility study

Introduction/Aim: Treatable traits based personalised medicine has been shown to improve outcomes in severe asthma clinic. We assessed the feasibility of a randomised controlled trial of protocolised 'focused' and 'extended' treatable trait guided asthma management in patients not under a severe asthma clinic. Method(s): Ten week single-group cohort study. Participants had a doctor's diagnosis of asthma, asthma control questionnaire (ACQ) score >1, and a history of exacerbation in the last year. Patients already under the care of a severe asthma clinic or receiving high-dose inhaled corticosteroids, biological therapy or maintenance oral corticosteroids were excluded. Intervention(s): asthma medication according to application of a 'focused' treatable trait algorithm, targeting type-2 inflammation and airflow obstruction. Feasibility outcomes: recruitment rates, acceptability of intervention, willingness to enrol in a full RCT, need for 'extended' trait assessment after 10 weeks, and estimation of trait prevalence. Result(s): Recruitment ceased after 14 months with 30/50 participants due to difficulties associated with COVID-19. 92% found the intervention acceptable and were willing to be randomised in a future study. 65% remained not well-controlled with an ACQ >1 after 10 weeks and would have required the 'extended' algorithm. Participants had a mean (SD) 4.8(2.3) of 13 traits assessed. Participation in the study was associated with clinically important improvements in ACQ, -1.0 (1.5) units;St George Respiratory Questionnaire, -15.1 (14.7) units;Asthma Quality of Life Questionnaire, +1.0 (1.1) units;and FEV1, +0.4 (0.4) L. Post-bronchodilator airflow obstruction reduced from 60% of participants at study commencement to 35%. 53% of participants were allocated continuous oral corticosteroids at some point during the study. Conclusion(s): Protocolised treatable trait management was acceptable, associated with significant clinical benefit and a full trial appears feasible. Targeting two traits was insufficient to control asthma in the majority of patients over the timeframe of this study, despite significant corticosteroid exposure.

Asthma as a comorbid disease in COVID-19

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus that causes coronavirus disease 2019 (COVID-19). In terms of asthma and COVID-19, there is also a risk of experiencing an asthma exacerbation triggered by coronavirus infection beyond the direct risk of the infection itself. As a comorbid disease, the prevalence of COVID-19 infection in asthma patients is not clear. In addition, the influence of asthma on the severity of COVID-19 has not been reported. The aim of this review was to summarize the reported worldwide data about the prevalence and the clinical characteristics of patients with asthma during COVID-19 infection.Copyright © 2020 Bilimsel Tip Yayinevi. All rights reserved.

Geographical differences in the use of oral corticosteroids in patients with severe asthma in Spain: heat map based on existing databases analyses.

BACKGROUND: Although there are currently alternative treatments to the long-term use of oral corticosteroids (OCS) in severe asthma, recent studies show excessive use depending on geography and differences in medical practice. The objective of the study was to describe the differences in OCS use for severe asthma across the Spanish geography. METHODS: This is a real-world study using existing databases (year 2019): longitudinal patient database (EMR), based on electronic medical records, and database of pharmacological consumption (Sell-in) in basic healthcare areas. With EMR, the percentage of OCS prescriptions corresponding to patients with severe asthma (ICD-9 "asthma" and prescription of biological treatment and/or high dose of inhaled corticosteroids/long-acting inhaled ß2 agonists) was calculated. This percentage was transferred to the OCS consumption of each basic healthcare area as reported in the Sell-in database and a national heat map was created. The estimation of OCS use in patients with severe asthma per 100,000 inhabitants for each region was calculated by grouping basic healthcare areas and the mean OCS use per patient for different regions in Spain was also estimated. RESULTS: Patients with severe asthma in Spain were mostly female (69.6%), with a mean age (SD) of 57.6 years (18.01). Median time (Pc25-Pc75) since asthma diagnosis was 83.1 months (34.65-131.56). Of all patients with OCS prescriptions in 2019 identified in EMR, 4.4% corresponded to patients with severe asthma. Regions with the highest OCS use were Asturias, Andalucía, and Galicia, whereas those with the lowest use were Navarra, Baleares, Madrid and País Vasco. The mean OCS use per patient with severe asthma in 2019 throughout Spain was 1099.85 mg per patient, ranging from 782.99 mg in Navarra to 1432.64 in Asturias. CONCLUSIONS: There are geographical differences between Spanish regions with respect to the use of OCS in patients with severe asthma. The national mean consumption of OCS per patient with severe asthma and year is above the limits that indicate good asthma control.

The Frequency and Severity of COVID-19 in Patients Receiving Biological Agents and Risk Factors: Experience of an Allergy Clinic

Objective: The effect of biological agents used in severe allergic diseases on the risk of coronavirus disease 2019 (COVID-19) and the course of the disease still remains unclear. The aim of the study was to evaluate retrospectively the frequency and severity of COVID-19 to determine risk factors and to present real-life data in patients using biological agents.Materials and Methods: Patients who have used omalizumab or mepolizumab for at least six months were questioned retrospectively in terms of a history of COVID-19. Patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) polymerase chain reaction (PCR) or serological IgG positivity, symptoms, lung involvement, the need for supplemental oxygen, hospital and intensive care admission, and mortality were queried. Results: Of the 71 patients (omalizumab/mepolizumab: 51/20) included in the study, the average age was 37.2 +/- 12.9, and the female/ male ratio was 46/25. Of the 11 patients (omalizumab/mepolizumab: 6/5) with SARS-CoV-2 positivity, two were hospitalized for pneumonia and needed oxygen. However, intensive care was not required and they survived. There was no significant difference between mepolizumab users who had COVID-19 and those who did not in terms of baseline and post-treatment 6th-month eosinophil values (p= 0.7, p= 0.59, respectively). It was established that eosinopenia developing after treatment did not increase the risk of COVID-19 in patients using mepolizumab [RR (95% Cl) 0.99 (0.97-1.02), p=0.88].Conclusion: According to our single center data, we found the risk of severe COVID-19 in patients using biological agents to be quite low. Especially, eosinopenia that developed after mepolizumab treatment did not constitute a risk factor for the severity of COVID-19.

COVID-19 disease and severe asthma: Qatar experience

Background: Globally there is uncertainty about the role of severe asthma on COVID-19 outcomes. In contrast to varying observations from initial studies, there is now increasing evidence suggesting that asthma is not associated with an increased risk of acquiring COVID-19 infection or subsequent complications and mortality as initially anticipated. Still, we are learning about the impact of severe asthma and its treatment and associated co-morbidities on COVID-19. Hence, we aimed to identify the risk and severity of COVID-19 disease among patients with severe asthma. Method(s): We conducted a retrospective chart review of subjects following in severe asthma clinic at Hamad Medical Corporation, from March 2020 to November 2021. COVID-19 disease was defined by having a positive RT-PCR. Result(s): We reviewed 99 patients with controlled severe asthma (Table 1), all patients were on regular moderate-high dose inhaled corticosteroids. 60 (60.6%) patients were on different biological medications. 6 (6 %) patients were on regular oral corticosteroids. Only 10 (10.1%) patients had confirmed COVID-19 disease (Table 1), none of them had a severe disease or required ICU admission or died. The presence of co-morbidities like diabetes mellitus, hypertension and obesity were similar between patients who had COVID-19 disease and those with no COVID-19 disease. Although 50% of patients with positive COVID-19 had exposure to oral steroids, 48% of the no infection group also had required oral steroids during the study period. Conclusion(s): Our data showed that patients with stable severe asthma are not at increased risk of getting COVID-19 disease;the infection rate is comparable to the national rate of 8.3%. Patients are also not at risk of severe infection, hospitalization, or death. Most of the patients who developed COVID-19 had mild disease and recovered well, moreover, COVID-19 had minimal impact on the course of asthma. This highlights the importance of continuing asthma medications during the pandemic. We did not observe the effect of co-existing co-morbidities and different treatments on the risk of COVID-19 disease. However, our results were limited by the small sample size and lack of data about suspected patients without confirmatory RT-PCR. Further studies are needed to reinforce this conclusion. (Figure Presented).

Dupilumab as a steroid-sparing treatment option in pediatric severe asthma and chronic rhinosinusitis with nasal polyps

Case report Chronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent comorbidity in severe asthma in adults. Both diseases share key pathophysiological mechanisms that can involve type-2 inflammatory pathways. However, this is an uncommon presentation in pediatric patients. Dupilumab, a fully human monoclonal antibody against IL-4Ralpha, inhibits IL-4/ IL-13 signaling, which are key drivers of type-2 inflammation and interfere with both eosinophilic and allergic pathways. It is approved for patients >= 12-year- old with moderate to severe uncontrolled asthma, but its approval in CRSwNP is limited to adults. We report a case of a 12-year- old boy with severe uncontrolled asthma and highly symptomatic CRSwNP referred to our center in May 2021. He was sensitized to house dust mite and pollens, and a specific immunotherapy had been tried previously. He was treated with high dose inhaled corticosteroid, long-acting beta agonist, long-acting muscarinic antagonist, montelukast and daily intra-nasal corticosteroids. Furthermore, a bilateral endoscopic sinus surgery with polypectomy was performed in April 2021. Despite adherence to medication and surgical treatment, both diseases were uncontrolled with frequent exacerbations requiring unscheduled visits and multiple systemic corticosteroid courses. This led to failure to thrive and several missed school days. Oral corticosteroid (OCS) tapering was unachieved due to symptoms rebound and so maintenance therapy with prednisolone 10mg daily was attempted, with only a slight improvement. High levels of eosinophils (1010 cells/muL), FeNO (122 ppb) and IgE (2255 kU/L) were present. Treatment with subcutaneous dupilumab was started in July 2021. A clinical and analytical improvement was evident at the 3-month evaluation (Table 1). He was able to stop prednisolone, and no clinically relevant exacerbations occurred. He also was fully vaccinated and had an asymptomatic COVID-19 infection in December 2021. Patients with CRSwNP and comorbid asthma have a higher disease burden than patients with each disease alone. In this adolescent, dupilumab was effective as an add-on treatment, for both severe asthma and CRSwNP. It led to disease control, OCS withdrawal, reduced eosinophilic inflammation, improved lung function, smell recovery and absence of exacerbations during follow-up. Dupilumab, targeting the type 2 inflammatory process, may allow a better management of pediatric patients >=12 years old with severe CRSwNP and comorbid asthma. (Table Presented).

Onasm@: Helping severe asthma patients to prepare the telematic visit with their specialist

Background: In March 2020, the state of alarm was declared in Spain due to the health crisis caused by SARS-COV-2. The rapid spread of the virus generated uncertainty and concern about the impact it could have on patients with severe asthma (SA) and boosted for the first time the use of teleconsultation for the management of these patients. For this reason, it was necessary to facilitate the transition to a hybrid model that combines face-to-face and digital consultations. Objective(s): Development of the first document designed for SA patients, aimed to support the preparation of the telematic follow-up consultations with their specialist. Method(s): Nine experts in SA from different specialties: 4 allergists, 3 pulmonologists and 2 asthma unit nurses contributed to the conceptualization and development of the document. In a first phase of conceptualization, the profile of patients to which the material is addressed was defined and the minimum content needed to be useful to both patients and healthcare professionals (HCPs) was established. A first draft was prepared and refined after evaluation by adult patients and parents of pediatric patients through cognitive interviews. Result(s): Onasm@ is the first document intended for SA patients to prepare the telematic follow-up consultation with their specialist. It consists of three blocks: A first one with general considerations to be applied on the telematic consultation, a second one to collect all the information that might be requested by the healthcare professional (HCP) during the off-site visit (asthma medications, dosage, adherence, asthma crisis events, emergency visits and oral corticosteroid use) and the third block with tips for achieving and maintaining asthma control. The asthma control test (ACTTM) for adults and the children's version (cACTTM) is also incorporated. Conclusion(s): The transition to a hybrid healthcare model due to the pandemic situation makes it essential to support SA patients to face the telematic follow-up consultation with their specialist. Onasm@ is the first document designed to help patients to appreciate the information needed to face this type of visit, with the aim to promote a fluid communication with their HCP and more efficient visits. This type of document could be applied to the management of other conditions and as such have broader impact on the future of healthcare, which is currently immersed in far-reaching change and transformation.

Incidence and clinical course of COVID-19 in patients with chronic idiopathic urticaria and asthma on omalizumab and mepolizumab: A single center real life experience

Background: Little is known about the course of COVID-19 in patients with severe asthma/chronic spontaneous urticaria (CSU) using biological agents. To assess the incidence and course of COVID-19 in patients with severe asthma/CSU using biological agents Method: A total of 202 patients (142 with asthma, 60 with CSU) were enrolled. The subjects were questioned via face-to- face or telephone interview whether they had been diagnosed with COVID-19 and the course of the disease. Result(s): Study group consisted of 132 women, 70 men (median age: 48 years). Thirty-one (15.3%) patients were diagnosed with COVID-19, 22 (71%) of whom were receiving omalizumab and 9 (29%) were receiving mepolizumab. Diagnosed with asthma or CSU, age, sex, smoking, weight, comorbidities, atopy and receiving biological agent were not statistically different between patients with or without COVID-19. Nine COVID -19 patients were hospitalised, three of them required intensive care. Mepolizumab usage was higher in hospitalised patients (5, 55.6%), whereas omalizumab usage was higher in home-treated patients (18, 81%). The mean duration of biologicals usage in home treated patients was significantly higher than that of the hospitalised patients (35.64 months vs.22.56 months, p = 0.024). Biological treatments were interrupted in 47 (23%) patients, self-interruption due to the infection risk was the foremost reason (34%) while having COVID-19 took the next place (28%). Conclusion(s): The incidence of COVID-19 among patients with asthma and CSU on mepolizumab and omalizumab was higher compared to studies from other countries. The disease course appeared mild in patients receiving long-term biological therapy.

Prevalence of asthmatic patients and clinical trend among hospitalized for Sars-Cov2 infection during the first pandemic wave in North-West Italy

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.

The frequency of SARS-CoV- 2 infection in patients with asthma and chronic urticaria receiving omalizumab

Background: W e w ould l ike t o s hare o ur c linical o bservations r egarding the incidence of Covid-19 in our chronic urticaria and asthma cases receiving omalizumab. Method(s): In our clinic, omalizumab treatment is given to a total of 23 patients, 13 with the diagnosis of chronic spontaneous urticaria (CSU) and 10 with the diagnosis of asthma. Although the mean age of our patients who received omalizumab for CSU was 17.4;10 (77%) were female and 3 (23%) were male. One of these patients, a 20-year- old girl, was found to have a positive PCR test for SARS-CoV- 2 and was treated with omalizumab during SARS-CoV- 2 infection. Our patient had a SARS-CoV- 2 infection with mild symptoms at home without using any other medication. The mean age of our patients who received omalizumab for asthma was 16.5 years. 6 (60%) of our asthma patients were male and 4 (40%) were female. SARS-CoV- 2 PCR test was detected in a 20-year- old female patient who received omalizumab with the diagnosis of moderate-severe asthma, and this patient had a SARS-CoV- 2 infection with mild symptoms without needing any medication, staying in isolation at home. Result(s): 2/23 (8.7%) of our patients who received omalizumab treatment had SARS-CoV- 2 infection with mild symptoms at home. We think that omalizumab treatment is not a treatment that will only cause comorbidity during the Covid-19 pandemic. We continue to apply omalizumab treatment to our patients without causing any worries. We fully agree that our results show that cases taking omalizumab for CSU or asthma are not at greater risk of contracting SARS-CoV- 2 infection than the general population and provide further support for the safety of omalizumab use during the COVID-19 pandemic. Conclusion(s): Even if they were infected, the course of the COVID-19 disease in our cases did not seem different from the general population. While using omalizumab, data on the course of COVID-19 in these diseases continue to increase day by day. However;We should be aware that severe cases of COVID-19 should be given extra attention when using omalizumab as recommended.

COVID 19 infection in children with asthma

Background: The pandemic period demonstrated the epidemiological and clinical evolutionary differences between adult vs. child with asthma infected with COVID 19. One of the challenges for pediatricians was the risk of losing control of asthma but also the risk of serious complications in the asthmatic child. The aim of the study was to study the level of control of asthma in children and on the other hand the incidence of its severe complications in the pandemic period 2020-2021 vs the non-pandemic period 2018-2019. Method(s): Retrospective study on asthmatic patients hospitalized in the period 2020-2021 in the Emergency Clinical Hospital for Children "St Mary" Iasi. Result(s): Total number of cases of asthma-2018- 219, 2019-174, 2020-193,2021- 148;annual asthma control level: controlled asthma: 2018-63%, 2019-59%, 2020-67%, 2021-54%, partially controlled asthma: 2018-29%, 2019-35%, 2020-26%, 2021 -38%, uncontrolled asthma: 2018-8%, 2019-6%, 2020-7%, 2021-8%;annual incidence of exacerbations: controlled asthma -2018: 23%, 2019-27%, 2020-11%, 2021 -14% of which with COVID 19 infection-2%;partially controlled asthma-2018: 41%, 2019-54%, 2020-32% of which with COVID 19 infection-21%;2021-58% of which with COVID19 infection- 42%;uncontrolled asthma-2018- 77%, 2019-73%, 2020-86% of which with COVID19 infection -82%, 2021-81% of which with COVID 19 infection-74%;annual incidence of severe asthma complications hospitalized ICU: 2018-3%, 2019-2%, 2020-5% of which 4% with COVID 19 infection,2021-4% all associated with COVID 19 infection. Conclusion(s): The control rate of asthma in children did not register significant differences between the 2 studied periods;The incidence of severe complications and exacerbations in the context of SARS Cov 2 infection increased during the pandemic period, especially in the partial and especially uncontrolled therapeutic form of asthma in children.

A flare of EGPA after vaccination for COVID-19, description and follow-up of a clinical case

Background: Although rarely, vaccines can stimulate the immunological mechanisms underlying immune-mediated inflammatory diseases. in patients with COVID-19 there is also evidence that high titers of autoantibodies, with variable clinical relevance, can be detected. Method(s): We describe the case of a 71-year- old lady diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA) in 2010 with paraesthesia, myalgia, eosinophilia and severe asthma. After induction of remission, the patient has shown regression of the vasculitis but persistence of the uncontrolled asthma. For this reason, since February 2019 she started Mepolizumab 100 mg/month. In December 2020 she tested positive for the SARS-CoV- 2 virus, manifesting a mild form then she tested negative in January 2021. In April 2021 she was vaccinated with a single dose of BNT162b2 mRNA vaccine. After about 10 days, she started to complain arthromyalgia and after a week of gait alteration, paraesthesia, dyspnoea and worsening cough associated with chest pain. Blood tests showed an increase in creatinephosphokinase (CPK 955 U/L) and hypereosinophilia (4.3x10

Mepolizumab effectiveness in severe asthma supported by federated analysis of European SHARP data

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).

Alveolar macrophages from people with severe eosinophilic asthma show differential antiviral responses to human rhinovirus 16 and SARS-CoV-2

Background: Rhinovirus is the most common trigger for exacerbations of asthma. Alveolar macrophages (AM) are a major site of RV infection and can also be infected by SARS-CoV-2. The pandemic caused by the SARS-CoV-2 raised concerns that patients with severe asthma (SA) would be at particularly high risk of developing severe disease. To date, evidence for poor outcomes in asthma remains limited suggesting a differential immune response to these two viruses. Method(s): Alveolar macrophages (AM) were isolated from bronchoalveolar lavage samples from patients with SA and infected with RV (n=13), SARS-CoV-2 alpha (B.1.1.7) (n=9) and delta (B.1.627.2)(n=8) variants. Antiviral mediators representing NF-KB-induced interferon-driven mRNAs (IL6 and IL8, RIGI and MDA5, respectively) were measured by qPCR, normalised to GAPDH and compared between infected AM and controls. Result(s): RV infected AM showed significant increases in mRNA expression of RIGI (4.39 fold change +/-4.68, p<0.001 vs control), MDA5 (2.96 fold change +/- 2.93, p=0.002 vs control) and IL6 (1.88 fold change +/- 0.98, p=0.006) compared to AM treated with control media alone, whilst IL8 did not significantly change. However, AM infected with SARS-CoV-2 alpha or delta variants showed no difference in levels of antiviral mediators compared to controls. Longitudinal analysis of AMs infected with SARS-CoV-2 alpha or delta variants showed no antiviral response. Conclusion(s): AM from subjects with severe asthma produce a pattern of anti-viral responses following RV infection that is absent when exposed to SARS-CoV-2 variants currently in circulation.

The effect of the COVID-19 pandemic on severe asthma care in Europe - will care change for good?

Background The COVID-19 pandemic has put pressure on health-care services forcing the reorganization of traditional care pathways. Aim To investigate;(1) how physicians taking care of severe asthma patients in Europe reorganized care during the COVID-19 pandemic;(2) patient satisfaction with these changes;and (3) impact on future care. Methods In this European-wide cross-sectional study, patient surveys were sent to patients with a physiciandiagnosis of severe asthma, and physician surveys to severe asthma specialists (November 2020 - May 2021). Results 1101 patients and 268 physicians from 16 European countries contributed to the study. Common physicianreported changes in severe asthma care included use of video/phone consultations (46%) and change to home administered biologics (38%), which resulted in high satisfaction levels in most patients (Figure 1). Many physicians expect continued implementation of video/phone consultations (41%) and home administration of biologics (52%). Conclusions Change to video/phone consultations and home administration of biologics was common in severe asthma care during the COVID-19 pandemic, and was associated with high satisfaction levels in most but not all cases. Many physicians expect these changes to continue in future severe asthma care, though satisfaction levels may change after the pandemic. (Figure Presented).

Spanish multidisciplinary consensus on the characteristics of severe asthma patients on biologic treatment who are candidates for at-home administration

Background and objective: Biologic therapies are known to reduce exacerbations and improve severe uncontrolled asthma management. The at-home administration of biologics has increased during the COVID-19 pandemic, but the characteristics of severe uncontrolled asthma patients who may benefit from at-home administration of biologic therapy have yet to be identified. Material(s) and Method(s): This project is based on the Delphi method, designed to reach an expert consensus through a multidisciplinary scientific committee addressing the following questions: clinical characteristics, treatment adherence, patient or caregiver administration ability, patient self-care, relationship with the healthcare professional, patient preference, and access to the hospital. Result(s): One hundred and thirty-one healthcare professionals (pulmonologists, allergists, nurses, and hospital pharmacists) completed two Delphi consensus questionnaires. Fourteen items were identified as priority characteristics, the first five being: 1. The patient follows the healthcare team's indications/recommendations to control their disease, 2. The patient is capable of detecting any deterioration in their disease and of identifying exacerbation triggers, 3. The patient receives biologic therapy and has stable disease with no vital risk, 4. The patient takes responsibility for their self-care, 5. The patient has occupational/educational obligations that prevent them from going to the hospital regularly. Conclusion(s): Disease stability and control plus the ability to identify exacerbation triggers are the most important characteristics when opting for at-home administration for a patient with severe uncontrolled asthma on biologic therapy. These recommendations could be applicable in clinical practice.Copyright © 2022