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1.
Adv Ther ; 39(12): 5307-5326, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2075678

ABSTRACT

Asthma is a heterogenous respiratory disease, usually associated with chronic airway inflammation and hyper-responsiveness, which affects an estimated 339 million people worldwide. Severe asthma affects approximately 5-10% of patients with asthma, approximately 17-34 million people globally, more than half of whom have uncontrolled disease. Severe asthma carries a substantial burden of disease, including unpredictable symptoms and potentially life-threatening flare-ups. Furthermore, severe asthma has a substantial burden on health care systems and economies worldwide. In 2018, a group of experts from the clinical community, patient support groups, and professional organisations joined together to develop the Severe Asthma Patient Charter, which set out six principles to define what patients should expect for the management of their severe asthma and what should constitute a basic standard of care. Since the publication of that original Charter in 2018, several important changes have occurred, including an improved understanding of asthma and effective asthma management; several new therapies have become available; and finally, the COVID-19 pandemic has placed a spotlight on respiratory conditions, the workforces that treat them, and the fundamental importance of health care system resilience. With those developments in mind, we, representatives of the academic, clinical, and patient advocacy group communities, have updated the Charter to Improve Patient Care in Severe Asthma with a focus on six principles: (1) I deserve a timely, comprehensive assessment of my asthma and its severity; (2) I deserve a timely, straightforward referral to an appropriate specialist for my asthma when it is not well controlled; (3) I deserve to understand what makes my asthma worse; (4) I deserve access to treatment and care that reduces the impact of asthma on my daily life; (5) I deserve not to be reliant on systemic corticosteroids; (6) I deserve to be involved in decisions about my treatment and care.


Subject(s)
Asthma , COVID-19 , Humans , Pandemics , Asthma/drug therapy , Patient Care , Referral and Consultation
2.
Pharmaceutical Journal ; 306(7950), 2022.
Article in English | EMBASE | ID: covidwho-2064960
3.
Chest ; 162(4):A2652-A2653, 2022.
Article in English | EMBASE | ID: covidwho-2060978

ABSTRACT

SESSION TITLE: Late Breaking Insights In Management of Asthma and COPD SESSION TYPE: Original Investigations PRESENTED ON: 10/18/2022 09:15 am - 10:15 am PURPOSE: SARS-CoV-2 vaccines have greatly reduced the impact of the COVID-19 pandemic. However, immune responses and their ability to protect against SARS-CoV-2 infection and severe clinical outcomes vary amongst vaccinees. Understanding who remains at high risk for severe infection despite vaccination and who may need additional vaccine boosters is critical for the control of this and future pandemics. We recently reported a reduced humoral immune response after mRNA SARS-CoV-2 vaccination in patients with severe asthma or atopic dermatitis on biologic therapies three months after the second vaccination, compared to healthy controls. The purpose of this study is to characterize the immune response of these patients six months after vaccination. METHODS: We conducted a prospective observational trial from February 2021 to February 2022 and enrolled 77 adults with severe asthma or atopic dermatitis treated with benralizumab, mepolizumab or dupilumab, receiving a SARS-CoV-2 mRNA vaccination, in addition to 45 healthy controls. We analyzed pseudovirus neutralization against wild-type, Delta variant and Omicron variant SARS-CoV-2, using a pseudotyped lentivirus. RESULTS: After excluding patients with prior COVID-19 or significant immunosuppression, we analyzed 28 patients (5 patients on benralizumab, 20 patients on dupilumab, 3 patients on mepolizumab) in addition to 34 healthy controls at 6 months after vaccination. We found that patients with severe asthma or atopic dermatitis treated with biologics had lower pseudovirus neutralization titer at 6 months, compared to healthy controls. The mean 50% inhibitory dilution against wild-type SARS-CoV-2 among patients on biologics were lower at 2.313 log10 compared to 2.743 log10 in the healthy control group, p-value <0.0001. Additionally, the patients on biologics had lower neutralizing antibody titers against Delta variant and Omicron variant SARS-CoV-2. CONCLUSIONS: Our data shows that patients with severe asthma or atopic dermatitis on biologic therapies have lower neutralization titer after SARS-CoV-2 mRNA vaccination compared to healthy controls 6 months after the second vaccination. Large population studies have recently shown that severe or active asthma is associated with worse COVID-19 outcomes and several studies have shown that lower humoral immunity after vaccination is associated with less protection against disease. It is therefore critical to provide booster vaccinations to these vulnerable patients. CLINICAL IMPLICATIONS: Clinicians should encourage patients with severe asthma or atopic dermatitis on biologic therapies to receive SARS-CoV-2 booster vaccinations as they may unknowingly remain at high risk for severe disease. DISCLOSURES: No relevant relationships by Fabliha Anam No relevant relationships by Suneethamma Cheedarla No relevant relationships by Narayanaiah Cheedarla No relevant relationships by John Daiss No relevant relationships by Natalie Haddad No relevant relationships by Ian Hentenaar No relevant relationships by Fernando Holguin No relevant relationships by Caroline Kim No relevant relationships by Pedro Lamothe No relevant relationships by Frances Lee No relevant relationships by ANDREW NEISH No relevant relationships by wendy neveu No relevant relationships by Rahulkumar Patel No relevant relationships by Carmen Polito No relevant relationships by Richard Ramonell No relevant relationships by Mayuran Ravindran No relevant relationships by John Roback No relevant relationships by Martin Runnstrom Consultant relationship with BLI, Inc. Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Royalty Consultant relationship with Bristol Meyers Squibb/Celgene Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Consulting fee Speaker/Speaker's Bureau relationship with Bristol Meyers Squibb/Celgene Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=H noraria Consultant relationship with GlaxoSmithKline Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Consulting fee Speaker/Speaker's Bureau relationship with GlaxoSmithKline Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Honoraria Consultant relationship with Janssen Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Consulting fee Speaker/Speaker's Bureau relationship with Janssen Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Honoraria Consultant relationship with Visterra Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Consulting fee Speaker/Speaker's Bureau relationship with Visterra Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Honoraria Consultant relationship with Kyverna Please note: past 36 months Added 07/18/2022 by Ignacio Sanz, value=Consulting fee No relevant relationships by Sunita Sharma No relevant relationships by Colin Swenson No relevant relationships by Robert Swerlick

4.
Chest ; 162(4):A2474, 2022.
Article in English | EMBASE | ID: covidwho-2060949

ABSTRACT

SESSION TITLE: Unique Uses of Pulmonary Function Tests SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Prevention of asthma exacerbations can be done through adequate self management at home. This study aimed to evaluate the feasibility and safety of a portable spirometer for unsupervised home spirometry measurements among patients with asthma. METHODS: A single center, prospective, single-arm, open study recruited 25 patients with moderate or severe asthma. After a 45 min video training session by a respiratory therapist, patients performed daily spirometry at home with the Spirobank Smart MIR mobile spirometry system that was bluetooth connected to the KevaTalk app. Each spirometry examination was recorded and evaluated according to the ATS/ERS acceptability and repeatability criteria. Patients had to perform at least three technically acceptable maneuvers with the KevaTalk app guiding them if they had a good or bad blow. The best value of the three maneuvers were used for subsequent analyses. Patients also entered their daily check ins and symptoms via the KevaTalk Asthma app, tracked their controller and rescue medication use, filled up ATAQ questionnaires as well as were reminded of their action plans. Data obtained from spirometry was reviewed by nurses and pulmonologist and the Keva365 remote monitoring platform prompted alerts based on patient checkins, use of medication and PEF values in the red or yellow zone. Any escalations based on nurse review were reported to the office. RESULTS: Mean age of the patients was 57 years. 1155 spirometry sessions were completed over the duration of 9 months of the study. Data for FEV1, FEV6, PEF FEV1/FVC, as well as the Best Predicted and LLN values was reviewed daily for patients. Flow volume loops during the sessions were reviewed to identify if the home spirometry was done correctly and retraining was provided if needed. The reported values were tracked over the duration the patient was enrolled in the Keva program. 60.9% of patients were found to have peak flows in their respective red zones at least once and 87% were found to have peak flows in their yellow zone at least once, during the course of the study. If 3 consecutive values were in the yellow or red zone along with worsening of symptoms, the physician's office was informed for further course of action. CONCLUSIONS: The COVID-19 pandemic led to paucity of in office spirometry and face-to-face visits for asthmatic patients. Increasing the availability of spirometry with handheld devices along with a remote monitoring platform is useful for improving asthma control and reducing the risk of asthma-related hospital admissions and deaths. CLINICAL IMPLICATIONS: Remote objective spirometry yields clinically meaningful information that helps with asthma patient management and prevent an exacerbation from becoming worse. DISCLOSURES: No relevant relationships by Karim Anis No relevant relationships by Varada Divgi No relevant relationships by Jyotsna Mehta No relevant relationships by Shail Mehta No relevant relationships by Denzil Reid

5.
Chest ; 162(4):A2473, 2022.
Article in English | EMBASE | ID: covidwho-2060948

ABSTRACT

SESSION TITLE: Unique Uses of Pulmonary Function Tests SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Asthma is one of the most common chronic respiratory illnesses affecting quality of life of patients, mortality as well as a high impact on health care utilization. In the era of the COVID19 pandemic, telemedicine and remote patient monitoring (RPM) have been heavily utilized by healthcare systems and providers for patient care. In our pilot program at a large US healthcare center, we enrolled patients known to have asthma to evaluate how RPM could be of value to both the patients and providers. METHODS: Patients included in the study had a confirmed diagnosis of moderate/severe asthma, were at least 18 years of age, and had access to an Android/iOS mobile device with internet access. The patients were excluded from the study for any conditions that would prevent them from using an app such as visual, cognitive, or other impairments that may prevent the patient from being able to participate. Patients were provided with a connected mobile spirometer, the KevaTalk app on their phones and educational introductory sessions during 9 months of the study. Each patient had their action plan and list of medications entered into the Keva365 platform by the nurse or the patient themselves. We provided a baseline patient questionnaire to assess usefulness and evaluate the app features, an ATAQ questionnaire for asthma control and a Smoking cessation questionnaire. Patients were asked to check in daily into the app as green (no symptoms), yellow (some symptoms) or red (bad symptoms). Patients were asked to perform spirometry using a connected spirometer. Remote monitoring protocols were set up for patients which included specific requirements for alerts being escalated to the pulmonologists. We monitored check-ins, alerts, and escalations during the study time window. RESULTS: A total of 25 patients were included in this pilot. Mean age was 57 and majority (23) were female. A baseline questionnaire rating the app, indicated that ease of check-in and ease of modification to the patient's asthma plan were the two highest rated features. 2066 total check ins (1550 green, 506 yellow and 10 red checkins) and 1155 spirometry sessions were recorded during this period. 484 alerts were recorded and evaluated by the monitoring team, of which 37% required an escalation to the physician requiring an intervention which included transfer to a medical facility, change in respiratory medication or further education. CONCLUSIONS: Patient driven engagement along with a well executed RPM program leads to increased compliance and improved outcomes among patients with respiratory illnesses. CLINICAL IMPLICATIONS: Our findings demonstrate preliminary evidence of the clinical impact of respiratory focused remote monitoring combined with a process for triaging our pulmonary patients. Adoption by pulmonolgists and allergists of these digital remote programs can pave the way for reduced physican burden, improved outcomes and reduced costs. DISCLOSURES: No relevant relationships by Karim Anis No relevant relationships by Jyotsna Mehta No relevant relationships by Shail Mehta No relevant relationships by Denzil Reid

6.
J Allergy Clin Immunol Pract ; 10(10): 2646-2656, 2022 10.
Article in English | MEDLINE | ID: covidwho-2049376

ABSTRACT

BACKGROUND: Patients with severe asthma may require maintenance oral corticosteroids (mOCS) for disease control as well as systemic corticosteroid (SCS) bursts for clinically significant exacerbations. However, mOCS and SCS use are associated with adverse effects, which increases patient disease burden. OBJECTIVE: To assess the real-world corticosteroid-sparing effect of mepolizumab in patients with severe asthma. METHODS: REALITI-A was a 24-month international, prospective, observational cohort study involving 84 centers across Europe, Canada, and the United States, with a 1-year pre-post mepolizumab treatment preplanned interim analysis. A total of 822 adults with a clinical diagnosis of asthma and a physician decision to initiate mepolizumab treatment (100 mg subcutaneously) were included. End points included daily mOCS dose at baseline (penultimate 28 days of pretreatment) and 1 year after treatment; percent reduction from baseline in mOCS dose; patients discontinuing mOCS 1 year after treatment; and the rate of clinically significant exacerbations (those requiring OCS for 3 days or more [or parenteral administration], emergency room visit, and/or hospital admission) before and after treatment. RESULTS: A total of 319 patients received mOCS at baseline (median [interquartile range]: 10.0 [5.0-15.0] mg/d). At 1 year after treatment, median mOCS dose was reduced by 75% (2.5 [0.0-5.0] mg/d); 64% of patients had a reduction in mOCS dose of 50% or greater compared with baseline and 43% discontinued mOCS. Clinically significant exacerbations decreased between pretreatment and posttreatment (rate ratio [95% confidence interval] 0.29 [0.26-0.32]; P < .001). CONCLUSION: This 1-year analysis demonstrates that real-world mepolizumab treatment is clinically effective in patients with severe asthma, providing disease control while reducing the need for mOCS and SCS bursts.


Subject(s)
Anti-Asthmatic Agents , Asthma , Adrenal Cortex Hormones/therapeutic use , Adult , Anti-Asthmatic Agents/therapeutic use , Antibodies, Monoclonal, Humanized , Asthma/chemically induced , Asthma/drug therapy , Humans , Prospective Studies
7.
Cureus ; 14(9): e28790, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2030316

ABSTRACT

Background The coronavirus disease 2019 (COVID-19) infection can have a variable impact on patients. Various host factors have been identified that play a significant role in the risk of COVID-19 infection and its severity. Patients with severe asthma have been clinically vulnerable since the first wave of the pandemic and the resurgence of COVID-19 in the United Kingdom in January 2020. In addition, those on treatment with monoclonal antibodies (mAbs) have been identified as being vulnerable to COVID-19 infection and severity by the World Health Organization and the Department of Health. However, the evidence to support this notion is limited, and there has been contrary evidence to suggest severe asthma is protective against COVID-19. In this study, a retrospective review of severe asthma patients in the Liverpool population between 1st January 2020 and 31st January 2021 was conducted. This study aimed to determine the association between asthma severity and the risk of COVID-19 infection and/or its severity for patients on mAb treatment. Methodology We conducted a review of all patients from the Liverpool severe asthma database/spreadsheet who tested positive in the community and at the hospital. Admission records, primary records, emails, and microbiological data for Anglia ICE were reviewed at the Royal Liverpool and Aintree University Hospital. A COVID-19 diagnosis was predefined as a positive lateral flow test and a positive polymerase chain reaction test. The proportion of patients with COVID-19 pneumonia and severe COVID-19 disease requiring hospital admission and escalation to intensive care (observation, intubation, continuous positive airway pressure) was noted. Other patient characteristics were recorded including age, weight, body mass index (BMI), gender, smoking status (never, former, current smoker), bronchiectasis, and the forced expiratory volume. Results In total, 760 patients were identified to have severe asthma, of whom 59 (7.8%) tested positive for COVID-19 and 701 (92.2%) tested negative. A total of 244 (32%) patients were taking mAbs, and 516 (68%) were not on mAb treatment. Patients were more susceptible to COVID-19 on an mAb (13.5%) versus non-mAb (5%) (odds ratio (OR) = 2.95; 95% confidence interval (CI) = 1.72 to 5.05) . A larger proportion of severe asthma patients on mAb treatment testing positive for COVID-19 were current smokers and had a higher BMI. Furthermore, severe asthmatics taking mAbs did not have a higher risk of severe COVID-19 disease, hospitalisation, and intensive care admission. Conclusions In the Liverpool severe asthma population, patients undergoing mAb therapy had a higher incidence of COVID-19 compared to non-mAb groups; however, they were not at a higher risk of severe disease progression. These findings suggest that continuing biologic therapy in severe asthmatics with COVID-19 appears to be safe to prevent exacerbations.

8.
J Allergy Clin Immunol Pract ; 10(9): 2312-2323.e2, 2022 09.
Article in English | MEDLINE | ID: covidwho-2015540

ABSTRACT

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.


Subject(s)
Asthma , Biological Products , Asthma/drug therapy , Biological Products/therapeutic use , Health Personnel , Humans , Qualitative Research , Social Support
9.
Pediatric Pulmonology ; 57, 2022.
Article in English | EMBASE | ID: covidwho-1965244

ABSTRACT

The proceedings contain 150 papers. The topics discussed include: machine learning in asthma research and clinical practice;the effect of climate change on pediatric respiratory health;lung involvement in systemic diseases;COVID-19: challenges, opportunities and lessons;biologicals in severe asthma: evidence and clinical practice;long-term non-invasive ventilation in children - state of the art;transition to adult care: what adults should know about pediatric respiratory diseases;pulmonology in the future;obesity and asthma in children;asthma diagnosis: new European Respiratory Society (ERS) guidelines;the impact of asthma exacerbations and prevention in LMIC;and long COVID in children - pulmonary manifestations and rehabilitation.

10.
Front Immunol ; 13: 892277, 2022.
Article in English | MEDLINE | ID: covidwho-1933679

ABSTRACT

Coronavirus disease 2019 (COVID-19) vaccines effectively elicit humoral and cellular immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy populations. This immunity decreases several months after vaccination. However, the efficacy of vaccine-induced immunity and its durability in patients with severe asthma on biological therapy are unknown. In this study, we evaluated the effectiveness and durability of mRNA vaccine-induced SARS-CoV-2-specific humoral and cellular immunity in severe asthma patients on biological therapy. The study included 34 patients with severe asthma treated with anti-IgE (omalizumab, n=17), anti-IL5 (mepolizumab, n=13; reslizumab, n=3), or anti-IL5R (benralizumab, n=1) biological therapy. All patients were vaccinated with two doses of the BNT162b2 mRNA vaccine with a 6-week interval between the doses. We found that this COVID-19 vaccination regimen elicited SARS-CoV-2-specific humoral and cellular immunity, which had significantly declined 6 months after receipt of the second dose of the vaccine. The type of biological treatment did not affect vaccine-elicited immunity. However, patient age negatively impacted the vaccine-induced humoral response. On the other hand, no such age-related impact on vaccine-elicited cellular immunity was observed. Our findings show that treatment of patients with severe asthma with biological therapy does not compromise the effectiveness or durability of COVID-19 vaccine-induced immunity.


Subject(s)
Asthma , COVID-19 , Antibodies, Viral , Asthma/therapy , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunity, Cellular , Immunity, Humoral , SARS-CoV-2 , Vaccination , Vaccines, Synthetic , mRNA Vaccines
11.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927925

ABSTRACT

Introduction: PrecISE is an ongoing Phase II clinical trial sponsored by the National Heart, Lung, and Blood Institute to investigate the efficacy of several treatments for severe asthma. The threat of COVID-19 has raised interest in obtaining reliable spirometry data for asthma research and clinical care in a remote, “no-touch” fashion. Prior studies of the accuracy of remote spirometry have not included real-time coaching. The PrecISE investigators hypothesized that remote spirometry with real-time video coaching could provide an accurate FEV1 for use as a study endpoint in a clinical trial setting. Methods: PrecISE network participants had remote spirometry post-bronchodilator (4 puffs of albuterol) measured with video coaching from trained research coordinators using the ZEPHYRx platform connected to MIR Spirobank Smart handheld spirometers. Remote spirometry measurements occurred within a +/- 3-day window from scheduled in-person PrecISE visits during which in-person spirometry with bronchodilator challenge was measured with standard equipment (Vyaire Medical). All measurements occurred during the screening/run-in period of the PrecISE protocol. Both remote and in-person spirometry was overread by the PrecISE Spirometry Core and only included in analysis if sessions met ATS acceptability and reproducibility criteria. Correlations between remote and in-person FEV1 and FVC were analyzed, and Bland-Altman plots generated. As a comparison, within subject biological variability was measured using data from separate in-person visits during the screening/run-in period. Results: A total of 128 pairs of remote/in-person spirometry data were obtained. The mean FEV1 for remote spirometry was 2.50 L (SD 0.81) and for inperson spirometry was 2.42 L (SD 0.80), with an estimated correlation of 0.95 (95% CI: 0.93, 0.97). The mean difference in FEV1 (in-person - remote) was -0.07 L (95% CI: -0.11, -0.03, SD 0.25). The mean FVC for remote spirometry was 3.72 L (SD 1.01) and for in-person spirometry was 3.53 L (SD 0.93), with an estimated correlation of 0.91 (95% CI: 0.87, 0.93). The mean difference in FVC (in-person - remote) was -0.19 L (95% CI: -0.27, -0.12, SD 0.42). A total of 142 pairs of repeated in-person spirometry measurements were performed (median time between measurements: 43 days), with mean difference in FEV1 of -0.01 L (95% CI: -0.06, 0.03) and FVC of -0.02 L (95% CI: -0.07, 0.03). Bland-Altman plots for FEV1 differences are shown in Figure 1. Conclusions: Remote spirometry with real-time video coaching provides a reliable FEV1 measurement which correlates closely with in-person spirometry and is suitable for use in clinical trials. (Figure Presented).

12.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927846

ABSTRACT

Introduction:Dupilumab is an anti-IL4R monoclonal antibody (mAb) with proven efficacy in severe eosinophilic asthma (SEA). We have previously identified that a suboptimal response to the eosinophil targeting anti-IL5/5R mAbs mepolizumab and benralizumab is seen in 27% and 14% of patients with SEA respectively1,2. The mechanism of this is not well-understood. It is unknown whether such patients respond in a clinically meaningful way following a switch to dupilumab. Methods:We performed a retrospective analysis of the clinical effectiveness of dupilumab (minimum 6 months treatment) in patients with SEA at our tertiary severe asthma centre who had failed to adequately respond to at least one of the anti-IL-5/5R mAbs. Change in the annualised exacerbation rate (AER), maintenance oral corticosteroids (mOCS) requirements, ACQ-6 and mAQLQ was recorded. Results:Thirty-two patients (mean age 41.2, 68.8% female, 71.9% atopic) were included in the analysis. 13/32(40.6%) had co-morbid nasal polyposis and 5/32(15.6%) had eczema. The baseline FeNO was 60ppb(IQR 39.6-87.5) and peak eosinophil count prior to any mAb was 0.6(IQR 0.5-0.9). 23/32(71.8%) were switched from benralizumab, of whom, 12/23(52.2%) had also failed to respond to at least one other anti-IL5 mAb previously. At six months, the daily median mOCS dose in those requiring mOCS at baseline (n=18) fell from 10mg(IQR 5-25mg) to 3mg(IQR 0-5mg), p≤0.001. 4/18(22%) were able to stop mOCS completely. Mean(SD) AER improved from 2.34(1.89) to 0.44(0.95), p≤0.001. There were also significant improvements in ACQ6 and mAQLQ that exceeded twice the MCID for both measures: mean (SD) ACQ6 improved from 3.04(1.26) to 1.82(1.28), p≤0.001;mAQLQ improved from 3.90(SD 1.40) to 5.36(SD 1.05), p≤0.001. Due to the COVID-19 pandemic, FEV1 data was only available for 8 patients. However, there was nonetheless a significant rise in FEV1 (%predicted) from 55.6% (9.78) to 68.5%(16.9), p=0.011. One patient discontinued dupilumab during the follow-up period. Conclusion: A minority of individuals with SEA have a suboptimal response to eosinophil targeted therapy with an anti-IL5/5R mAb. In these patients, we report significant clinical improvements following initiation with dupilumab suggesting an important role for the IL-4/-13 pathway in these patients. Further research is required to understand whether these patients represent a distinct subphenotype of T2-high asthma.

13.
Respir Med ; 200: 106916, 2022.
Article in English | MEDLINE | ID: covidwho-1907739

ABSTRACT

Patients with respiratory diseases suffer more from problems of severe psychiatric comorbidity than the general population. Asthma might cause psychiatric disorders and affect patients' quality of life negatively. Previous studies reported that mental disorders prevail in asthmatic patients, causing anxiety, depression, and suicidal risk. The aim of this study is to evaluate in real life the prevalence of psychological comorbidities in asthmatics with severe asthma treated by biologicals (Benralizumab, Mepolizumab, Omalizumab). This study starts with the hypothesis that psychological distress, anxiety, depression and suicidal risk in severe asthma patients decreases if treated by biologicals. This study involves a sample of 90 patients (32 males, 58 females and aged 53.92 ± 15.92) suffering from severe asthma and treated with the biological drugs of Benralizumab, Mepolizumab, Omalizumab during Covid-19 pandemic. At the beginning of the treatment (T0) and after 16 weeks (T1), there have been reported results from both clinical disease control, assessed using the ACT, and psychological disorders, assessed with the PSS, HADS and C-SSRS. In the sample of these patients treated with biologicals for severe asthma, the study reported a significant change in all observed parameters, including asthma control (ACT), stress (PSS), anxiety (HADS-A) and depressive symptoms (HADS-D, despite Covid-19 pandemic. In addition, there was a significant improvement in disease management, perceived stress, anxiety and depressive symptoms after a 16 week treatment for severe asthma, independent from the type of biologic drugs used during the pandemic.


Subject(s)
Asthma , Biological Products , COVID-19 , Psychological Distress , Anxiety/drug therapy , Anxiety/epidemiology , Anxiety/etiology , Asthma/drug therapy , Asthma/epidemiology , Biological Products/therapeutic use , COVID-19/complications , COVID-19/drug therapy , COVID-19/epidemiology , Depression/diagnosis , Depression/drug therapy , Depression/epidemiology , Female , Humans , Male , Omalizumab , Pandemics , Quality of Life , SARS-CoV-2 , Stress, Psychological/psychology
14.
J Allergy Clin Immunol Pract ; 10(10): 2588-2595, 2022 10.
Article in English | MEDLINE | ID: covidwho-1907243

ABSTRACT

BACKGROUND: At the beginning of the pandemic, there have been considerable concerns regarding coronavirus disease 2019 (COVID-19) severity and outcomes in patients with severe asthma treated with biologics. OBJECTIVE: To prospectively observe a cohort of severe asthmatics treated with biologics for the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and disease severity during the COVID-19 pandemic. METHODS: Physicians from centers treating patients with severe asthma all over Greece provided demographic and medical data regarding their patients treated with biologics. Physicians were also asked to follow up patients during the pandemic and to perform a polymerase chain reaction test in case of a suspected SARS-Cov-2 infection. RESULTS: Among the 591 severe asthmatics (63.5% female) included in the study, 219 (37.1%) were treated with omalizumab, 358 (60.6%) with mepolizumab, and 14 (2.4%) with benralizumab. In total, 26 patients (4.4%) had a confirmed SARS-CoV-2 infection, 9 (34.6%) of whom were admitted to the hospital because of severe COVID-19, and 1 required mechanical ventilation and died 19 days after admission. Of the 26 infected patients, 5 (19.2%) experienced asthma control deterioration, characterized as exacerbation that required treatment with systemic corticosteroids. The scheduled administration of the biological therapy was performed timely in all patients with the exception of 2, in whom it was postponed for 1 week according to their doctors' suggestion. CONCLUSION: Our study confirms that despite the initial concerns, SARS-CoV-2 infection is not more common in asthmatics treated with biologics compared with the general population, whereas the use of biologic treatments for severe asthma during the COVID-19 pandemic does not seem to be related to adverse outcomes from severe COVID-19.


Subject(s)
Asthma , Biological Products , COVID-19 , Adrenal Cortex Hormones , Asthma/drug therapy , Asthma/epidemiology , Biological Products/therapeutic use , Female , Humans , Male , Omalizumab/therapeutic use , Pandemics , SARS-CoV-2
15.
J Asthma Allergy ; 15: 623-632, 2022.
Article in English | MEDLINE | ID: covidwho-1869275

ABSTRACT

Introduction: The increase in drugs available for severe uncontrolled asthma and the lifestyle of these patients make it necessary to implement self-administration programs of these therapies at home. Benralizumab, a monoclonal antibody targeting IL5R, was authorized in Spain for poorly controlled severe eosinophilic asthma. The possibility of administration at home was approved in March 2020 in Spain. The aim of the Auto-Benra study was to evaluate the usability and satisfaction of the benralizumab prefilled syringe and autoinjector and assessing the effectivity of these devices in uncontrolled severe eosinophilic asthma (SEA) in home-self administration. Methods: This is a retrospective, observational multicenter study uncontrolled SEA patients treated with benralizumab at least with 3 doses self-administered at home before April 30, 2021. Reliability and satisfaction with benralizumab at home were evaluated with subcutaneous administration assessment questionnaire (SQAAQ) and visual analogic scales (VAS). Effectiveness was evaluated in all patients with asthma control test (ACT), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), annual exacerbation rate, oral corticosteroid treatment (OCS) and asthma-related hospitalizations and emergency visits. Results: Fifty-four patients across 9 hospitals in Spain were included. The mean SQAAQ score was 6.89 (±0.16) points. Patients and their caregivers and doctors report excellent satisfaction by VAS, with no differences between benralizumab devices used (prefilled syringe and autoinjector). Severe exacerbation rate decreased by 65% (p = 0.0007) after benralizumab treatment. ACT score improved on average 6.27 ± 5.35 points (p < 0.0001) and the mean MiniAQLQ increased up to 1.58 ± 1.47 points (p < 0.0001). Twenty-four patients were OCS-dependent and at the end of study 14 patients get complete OCS withdrawal. Conclusion: AUTO-BENRA study supports the use of benralizumab at home given the excellent results of satisfaction and usability by patients and their caregivers.

16.
Biomedicines ; 9(12)2021 Dec 03.
Article in English | MEDLINE | ID: covidwho-1785519

ABSTRACT

BACKGROUND: The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. PATIENTS AND METHODS: Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. RESULTS: In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). CONCLUSION: The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment.

17.
Embase; 2022.
Preprint in English | EMBASE | ID: ppcovidwho-332520

ABSTRACT

The COVID-19 vaccines effectively elicit humoral and cellular immunity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a healthy population. This immunity decreases several months after the vaccination. However, the efficacy of the vaccine-induced immunity and its durability in patients with severe asthma on biological therapy is unknown. In this study, we evaluated the effectiveness and durability of the mRNA vaccine-induced SARS-CoV-2-specific humoral and cellular immunity in severe asthma patients on biological therapy. The study included 37 patients with severe asthma treated with anti-IgE (omalizumab, n=18), anti-IL5 (mepolizumab, n=14;reslizumab, n=4), or anti-IL5R (benralizumab, n=1) biological therapy. All patients were vaccinated with two doses of BNT162b2 mRNA vaccine (Comirnaty) at a 6-week period between the doses. We found that the COVID-19 vaccination elicited SARS-CoV-2-specific humoral and cellular immunity, which significantly declined 6 months after the second dose of the vaccine. The type of biological treatment did not affect the vaccine-elicited immunity. However, the patients' age negatively impacted the vaccine-induced humoral response. On the other hand, no such age-related impact was observed on the vaccine-elicited cellular immunity. Our findings showed that biological therapy of patients with severe asthma does not compromise the effectiveness and durability of the COVID-19 vaccine-induced immunity.

18.
Children (Basel) ; 9(3)2022 Mar 01.
Article in English | MEDLINE | ID: covidwho-1715146

ABSTRACT

Currently, asthma represents the most common chronic disorder in children, showing an increasingly consistent burden worldwide. Childhood asthma, similar to what happens in adults, is a diversified disease with a great variability of phenotypes, according to genetic predisposition of patients, age, severity of symptoms, grading of risk, and comorbidities, and cannot be considered a singular well-defined disorder, but rather a uniquely assorted disorder with variable presentations throughout childhood. Despite several developments occurring in recent years in pediatric asthma, above all, in the management of the disease, some essential areas, such as the improvement of pediatric asthma outcomes, remain a hot topic. Most treatments of the type 2 (T2) target phenotype of asthma, in which IL-4, IL-5, and IL-13 modulate the central signals of inflammatory reactions. Although, there may be an unresolved need to identify new biomarkers used as predictors to improve patient stratification using disease systems and to aid in the selection of treatments. Moreover, we are globally facing many dramatic challenges, including climate change and the SARS-CoV2 pandemic, which have a considerable impact on children and adolescent asthma. Preventive strategies, including allergen immunotherapy and microbiome evaluation, and targeted therapeutic strategies are strongly needed in this population. Finally, the impact of asthma on sleep disorders has been reviewed.

19.
European Respiratory Journal ; 58:2, 2021.
Article in English | Web of Science | ID: covidwho-1708442
20.
European Respiratory Journal ; 58:2, 2021.
Article in English | Web of Science | ID: covidwho-1707652
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