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Severe Asthma and Biological Therapy: When, Which, and for Whom.

ABSTRACT: Asthma is a heterogeneous chronic inflammatory disease of the airways that affects approximately 300 million people worldwide. About 5-10% of all asthmatics suffer from severe or uncontrolled asthma, associated with increased mortality and hospitalization, reduced quality of life, and increased health care costs. In recent years, new treatments have become available, and different asthma phenotypes characterized by specific biomarkers have been identified. Biological drugs are currently indicated for patients with severe asthma that is not controlled with recommended treatments. They are mostly directed against inflammatory molecules of the type 2 inflammatory pathway and are effective at reducing exacerbations, maintaining control over asthma symptoms, and reducing systemic steroid use, which is associated with well-known adverse events. Although biological drugs for severe asthma have had a major impact on the management of the disease, there is still a need for head-to-head comparison studies of biologics and to identify new biomarkers for asthma diagnosis, prognosis, and response to treatment. Identifying novel biomarkers could facilitate the development of therapeutic strategies that are precisely tailored to each patient's requirements.

SUBMITTER: Rogliani P

PROVIDER: S-EPMC7229123 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Severe Asthma and Biological Therapy: When, Which, and for Whom.

Rogliani Paola P Calzetta Luigino L Matera Maria Gabriella MG Laitano Rossella R Ritondo Beatrice Ludovica BL Hanania Nicola A NA Cazzola Mario M

Pulmonary therapy 20191226 1

Asthma is a heterogeneous chronic inflammatory disease of the airways that affects approximately 300 million people worldwide. About 5-10% of all asthmatics suffer from severe or uncontrolled asthma, associated with increased mortality and hospitalization, reduced quality of life, and increased health care costs. In recent years, new treatments have become available, and different asthma phenotypes characterized by specific biomarkers have been identified. Biological drugs are currently indicate ...[more]

PMID: 32048241

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Project description:BackgroundSevere asthma is a serious condition with a significant burden on patients' morbidity, mortality, and quality of life. Some biological therapies targeting the IgE and interleukin-5 (IL5) mediated pathways are now available. Due to the lack of direct comparison studies, the choice of which medication to use varies. We aimed to explore the beliefs and practices in the use of biological therapies in severe asthma, hypothesizing that differences will occur depending on the prescribers' specialty and experience.MethodsWe conducted an online survey composed of 35 questions in English. The survey was circulated via the INterasma Scientific Network (INESNET) platform as well as through social media. Responses from allergists and pulmonologists, both those with experience of prescribing omalizumab with (OMA/IL5) and without (OMA) experience with anti-IL5 drugs, were compared.ResultsTwo hundred eighty-five (285) valid questionnaires from 37 countries were analyzed. Seventy-on percent (71%) of respondents prescribed biologics instead of oral glucocorticoids and believed that their side effects are inferior to those of Prednisone 5 mg daily. Agreement with ATS/ERS guidelines for identifying severe asthma patients was less than 50%. Specifically, significant differences were found comparing responses between allergists and pulmonologists (Chi-square test, p < 0.05) and between OMA/IL5 and OMA groups (p < 0.05).ConclusionsUncertainties and inconsistencies regarding the use of biological medications have been shown. The accuracy of prescribers to correctly identify asthma severity, according to guidelines criteria, is quite poor. Although a substantial majority of prescribers believe that biological drugs are safer than low dose long-term treatment with oral steroids, and that they must be used instead of oral steroids, every effort should be made to further increase awareness. Efficacy as disease modifiers, biomarkers for selecting responsive patients, timing for outcomes evaluation, and checks need to be addressed by further research. Practices and beliefs regarding the use of asthma biologics differ between the prescriber's specialty and experience; however, the latter seems more significant in determining beliefs and behavior. Tailored educational measures are needed to ensure research results are better integrated in daily practice.

Project description:ObjectivesThis study aims to analyze the reimbursement and cost of biological therapy for severe asthma in Bulgaria during 2014-2019 from the perspective of the National Health Insurance Fund.MethodsIt is a retrospective, Marco-costing, top-down study of the expenditures for biological products for severe asthma. The changes in the cost paid by the National Health Insurance Fund per year, per product, and per patient during 2015-2020 were systematized and calculated. The utilization of biologicals was analyzed by calculating the defined daily dose/1000inh/day. Three databases were searched-the European Medicines Agency for the date of marketing authorization of biological products, National Council of Prices and Reimbursement for the date of their respective inclusion in the positive drug list, and National Health Insurance Fund about the number of patients with asthma, reimbursed sum for all asthma patients, and number of packages sold of biological products.ResultsAt the end of 2019, five international non-proprietary names of biologicals with indication for severe asthma had received European marketing authorization, and three of them were included in the Bulgarian positive drug list-omalizumab, mepolizumab, and benralizumab with a 75% reimbursement. Upon their introduction into the positive drug list, the reimbursed expenditures for asthma therapy started to increase from 27 million in 2014 to 33 million BGN in 2019 (€13.5-€16.5 million). The cost of therapy with biologicals rose from 16% to 24% of all anti-asthmatic medicines budget. The National Health Insurance Fund database reported that between 47,000 and 52,000 of patients with asthma, 466 are on biological therapy. The yearly cost of one asthma patient ranges between 512 and 615 BGN (€258-€307), and the yearly per-patient cost of severe asthma is 16,666 BGN (appr. €8333). Total utilization in defined daily dose/1000inh/day increases from 0.0199 to 0.0383 from 2015 to 2019.ConclusionThe access to biological therapy through the reimbursement system has improved during the last 3 years. The cost of therapy is posing a high burden on the National Health Insurance Fund and on the patients and is expected to increase due to the small number of patients on biological therapy currently in comparison to all reimbursed asthmatics.

Project description:BackgroundAnti-T2 biological therapies have proven to effectively reduce acute exacerbations and daily doses of oral steroids in severe eosinophilic asthma. Despite the remarkable clinical efficacy, there are usually only moderate improvements in airflow limitation, suggesting that other measures of lung function like small airway dysfunction (SAD) might better reflect the clinical response. We aimed to investigate if measures of small airway function would predict and correlate with the clinical response to anti-T2 therapy.MethodsWe studied data of patients who were previously included in the German prospective longitudinal All Age Asthma Cohort (ALLIANCE) that recruits asthma patients of all severity grades and inflammatory phenotypes. The selection criteria for this analysis were adult patients with severe eosinophilic asthma under treatment with anti-T2 biological agents. Asthma control was assessed by asthma control test (ACT) and number of severe exacerbations. Small airway function was assessed by the frequency dependence of resistance (FDR, R5-20)) derived from impulse oscillometry (IOS) and the mean forced expiratory flow between 25 and 75% of the forced vital capacity (FEF25-75). We also studied air trapping (RV and RV/TLC), blood eosinophils and FeNO. Patients were classified into responders and partial or non-responders. Clinical response was defined as at least 50% reduction in annualized severe exacerbations and daily oral steroid doses accompanied with a minimum increase of 3 points in the ACT score. We used a Receiver Operator Characteristic (ROC) to study the capacity of FDR in predicting clinical response compared to other clinical variable like blood eosinophils. We studied the correlation between FDR measures and clinical response, represented by the ACT score and number of exacerbations, using linear regressions.Results20 patients were included (mean age, 59 ± 9 years; 60% female; mean body mass index (BMI), 27.6 ± 5.4 kg/m2; mean absolute blood eosinophils, 570 ± 389/µl; mean number of severe exacerbations 12 months prior to initiating the biological therapy, 5.0 ± 3; mean predicted FEV1, 76 ± 21%; mean predicted FDR, 224 ± 140%; mean daily prednisolone dose, 6.4 ± 4.9 mg; mean ACT score, 15 ± 5). Responders had significantly higher baseline FDR compared to partial or non-responders but similar FEV1, FEF25-75, RV and RV/TLC. ROC analysis showed that the combination of FDR and blood eosinophils had the best predictive capacity of the clinical response among all tested clinical markers (FeNO, FEV1, FDR, blood eosinophils) with an AUC of 85% [67-100%], (CI = 0.95, p = 0.01). Linear regressions indicated better associations between improvements in FDR and ACT score (R2 = 0.42, p = 0.001) than with FEV1 and ACT score (R2 = 0.25, p = 0.013). Likewise, we observed better associations between improvements in FDR and reduction of exacerbations (R2 = 0.41, p = 0.001) than with FEV1 (R2 = 0.20, p = 0.025).ConclusionOur data suggest that severe SAD may represent a distinct phenotype of eosinophilic asthma that substantially improves under anti-T2 biological therapy. Measures of small airway function might be useful in selecting appropriate patients qualifying for anti-T2 biological therapy in addition to blood eosinophil count.

Dataset Information

Severe Asthma and Biological Therapy: When, Which, and for Whom.

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Severe Asthma and Biological Therapy: When, Which, and for Whom.

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