Real-life experience after 3 months with tezepelumab before marketing approval.

BACKGROUND: Tezepelumab is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), implicated in asthma pathogenesis, and that has been approved for patients with severe uncontrolled asthma in Spain in October 2023. This study evaluates our experience with Tezepelumab for those patients who received the indicated drug off-label prior to its commercialization. METHODS: We conducted a real-life observational study on three patients from the Severe Asthma Unit of the Hospital Universitario de Fuenlabrada, Spain, who received Tezepelumab off-label before its official approval. We analyzed symptoms control based on ACT, exacerbations, reductions in the doses of oral corticosteroid, lung function, blood changes and safety at 3 months of treatment. RESULTS: Tezepelumab demonstrated efficacy in improving asthma control and a notable reduction in emergency department visits. OCS use decreased, with one patient halving their prednisone dose. Lung function, particularly FEV1 and FEV1/FVC parameters, improved, but no significant changes were observed in FeNO levels, blood eosinophil counts and total IgE. The treatment exhibited a favorable safety profile with no reported adverse effects during the study period. CONCLUSIONS: In this preliminary real-world experience prior to the official approval of tezepelumab in Spain, this monoclonal antibody showed promising results and suggests its potential as a valuable alternative for the treatment of severe asthma.

Real-life experience after 3 months with tezepelumab before marketing approval / Experiencia de la vida real después de 3 meses con tezepelumab antes de la aprobación de comercialización

Background: Tezepelumab is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), implicated in asthma pathogenesis, and that has been approved for patients with severe uncontrolled asthma in Spain in October 2023. This study evaluates our experience with Tezepelumab for those patients who received the indicated drug off-label prior to its commercialization. Methods: We conducted a real-life observational study on three patients from the Severe Asthma Unit of the Hospital Universitario de Fuenlabrada, Spain, who received Tezepelumab off-label before its official approval. We analyzed symptoms control based on ACT, exacerbations, reductions in the doses of oral corticosteroid, lung function, blood changes and safety at 3 months of treatment. Results: Tezepelumab demonstrated efficacy in improving asthma control and a notable reduction in emergency department visits. OCS use decreased, with one patient halving their prednisone dose. Lung function, particularly FEV1 and FEV1/FVC parameters, improved, but no significant changes were observed in FeNO levels, blood eosinophil counts and total IgE. The treatment exhibited a favorable safety profile with no reported adverse effects during the study period. Conclusions: In this preliminary real-world experience prior to the official approval of tezepelumab in Spain, this monoclonal antibody showed promising results and suggests its potential as a valuable alternative for the treatment of severe asthma.(AU)

Safety and efficacy of benralizumab in elderly subjects with severe asthma.

INTRODUCTION: The prevalence of asthma in adults >65 years old is approximately 12-14%, and 10% have severe asthma. A higher mortality rate is observed in subjects with asthma >65 years old and especially >80 years old. OBJECTIVE: To analyze the effectiveness and safety of at least three doses of benralizumab in a subgroup of elderly subjects (>65 years old) with uncontrolled severe eosinophilic asthma in real-life conditions. METHODS: This was a retrospective multicenter study (AUTOBENRA study) conducted in 9 hospitals that included 72 patients aged >18 years old with uncontrolled severe asthma based on the Spanish Asthma Guidelines who were treated with at least three doses of benralizumab, self-administered at home since before April 30, 2021. The recruitment period ended on October 1, 2021. Written consent was obtained before the study commencement. In this subanalysis, we compared the results between patients >65 years old and patients <65 years old. RESULTS: A total of 72 subjects with severe asthma were screened, and 54 were included (MD: 57.3 ± 10 years old). There were 12 subjects aged >65 years old [MD: 69.8 ± 4.3 years old (minimum: 65 years old; maximum: 83 years old)]. Subjects >65 years old experienced statistically significant improvement in lung function, ACT and mini-AQLQ with benralizumab. Additionally, 9 patients (75%) experienced no asthma exacerbation (p = 0.0047), half (3/6) were able to stop OCS (p = 0.08), and no adverse effects with benralizumab were reported during the 20 months of follow-up. CONCLUSIONS: In patients aged >65 years old, benralizumab was an effective and safe therapy for severe eosinophilic asthma in our study, with no significant differences from the younger subgroup. This is especially important since they are a group with numerous comorbidities, medications and worse quality of life.

[Telemedicine and severe asthma in our environment: Views on the experience of professionals and suggestions to make it a reality]. / Telemedicina y asma grave en nuestro entorno: reflexiones sobre la experiencia de los profesionales y propuestas para hacerla realidad.

This paper aims to examine the recent experience in telemedicine (TM) management of patients with severe asthma (SA). A committee of health professionals involved in asthma management (pulmonology, allergology, respiratory nursing, and hospital pharmacy) held discussion meetings on the practical experience of TM for the management of SA and the means available complemented with a bibliographic search to know the current status of TM in SA. The main barriers detected for the implementation of TM in SA have been the lack of technological training, the lack of registration of TM in the clinical history, the care overload, or the connectivity problems at the administration level. The practical solutions are provided such as the selection of the patient suitable for TM, the registration of TM in the medical record, its inclusion in the care objectives or the increase of funding for systems. Moreover, the main App and Webapp for use by patients are provided, and the portable equipment for remote functional respiratory tests. In conclusion, it is necessary that the teleconsultation has the same entity as the face-to-face visit with a schedule in the appointment's agenda and a structure of both the medical interview and the tests to be performed in each consultation. Additionally, should be promoted the implementation of a video call system, tools that allow the monitoring of both therapeutic adherence and inhalation technique, as well as the patient's lung function.

Reliability, Satisfaction and Effectiveness of Benralizumab Home Self-Administration in Patients with Severe Eosinophilic Asthma in Real-World Practice: The Auto-Benra Study.

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.

COVID-19 Course in Allergic Asthma Patients: A Spanish Cohort Analysis.

PURPOSE: The acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has had a high impact on patients with chronic diseases. In the literature, there are different perspectives on asthma as comorbidity or risk factor on COVID-19 severity. PATIENTS AND METHODS: The aim of this retrospective study across 13 allergy departments in Spain was to determine the severity of COVID-19 in asthmatic adults followed in allergy departments and its relationship with atopy, clinical and demographic characteristics, phenotypes and laboratory data. In addition, lung function test and asthma control test (ACT) before and after COVID-19 were analyzed. Data was obtained from electronic medical records from March 2020 to April 2021. RESULTS: Two hundred one asthmatic patients were diagnosed with COVID-19 infection by validated detection test. About 30% of the patients were admitted for bilateral pneumonia. Advanced age, elevated D-dimer, lower numbers of lymphocytes and eosinophils, heart diseases and hypertension were associated with severe COVID-19. Allergic and mixed allergic/eosinophilic phenotype and their biomarkers (total IgE, aeroallergens sensitizations, allergic rhinitis, and blood eosinophilia) were related to fewer hospital admissions. Poor control and lower forced expiratory volume in the first second (FEV1) were related to worse prognosis of COVID-19. CONCLUSION: Asthmatic patients with allergic and eosinophilic phenotype have a better evolution of COVID-19 and lower risk of admissions. Older patients, cardiovascular comorbidities, AERD and eosinopenia are related to severity COVID-19.