scholarly journals Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma

2020 ◽  
Vol 55 (5) ◽  
pp. 1902259 ◽  
Author(s):  
Gráinne d'Ancona ◽  
Joanne Kavanagh ◽  
Cris Roxas ◽  
Linda Green ◽  
Mariana Fernandes ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Biologic Therapy ◽  
Inhaled Corticosteroids ◽  
Final Analysis ◽  
Good Adherence ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Asthmatic Patients ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients

IntroductionInhaled corticosteroids (ICS) achieve disease control in the majority of asthmatic patients, although adherence to prescribed ICS is often poor. Patients with severe eosinophilic asthma may require treatment with oral corticosteroids (OCS) and/or biologic agents such as mepolizumab. It is unknown if ICS adherence changes on, or alters clinical response to, biologic therapy.MethodsWe examined ICS adherence and clinical outcomes in OCS-dependent severe eosinophilic asthma patients who completed 1 year of mepolizumab therapy. The ICS medicines possession ratio (MPR) was calculated (the number of doses of ICS issued on prescription/expected number) for the year before and the year after biologic initiation. Good adherence was defined as MPR >0.75, intermediate 0.74–0.51 and poor <0.5. We examined outcomes after 12 months of biologic therapy, including OCS reduction and annualised exacerbation rate (AER), stratified by adherence to ICS on mepolizumab.ResultsOut of 109 patients commencing mepolizumab, 91 who had completed 12 months of treatment were included in the final analysis. While receiving mepolizumab, 68% had good ICS adherence, with 16 (18%) having poor ICS adherence. ICS use within the cohort remained similar before (MPR 0.81±0.32) and during mepolizumab treatment (0.82±0.32; p=0.78). Patients with good adherence had greater reductions in OCS dose (median (interquartile range) OCS reduction 100 (74–100)% versus 60 (27–100)%; p=0.031) and exacerbations (AER change −2.1±3.1 versus 0.3±2.5; p=0.011) than those with poor adherence. Good ICS adherence predicted the likelihood of stopping maintenance OCS (adjusted OR 3.19, 95% CI 1.02–9.94; p=0.045).ConclusionICS nonadherence is common in severe eosinophilic asthma patients receiving mepolizumab, and is associated with a lesser reduction in OCS requirements and AER.

scholarly journals Clinical and economic consequences of switching from omalizumab to mepolizumab in uncontrolled severe eosinophilic asthma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Giovanna Elisiana Carpagnano ◽  
Emanuela Resta ◽  
Massimiliano Povero ◽  
Corrado Pelaia ◽  
Mariella D’Amato ◽  
...  
Keyword(s):  
Disease Onset ◽  
National Health System ◽  
Healthcare Spending ◽  
Blood Eosinophil ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Serum Ige ◽  
Asthmatic Patients ◽  
Severe Eosinophilic Asthma

AbstractSevere asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS), which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics, but not optimally controlled by omalizumab. We retrospectively enrolled uncontrolled severe asthmatic patients who switched from OMA to MEP during the last two years. Information included blood eosinophil count, asthma control test (ACT), spirometry, serum IgE, fractional exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and diagnostic exams. Within the perspective of Italian National Health System, a pre- and post-MEP 12-month standardized total cost per patient was calculated. 33 patients were enrolled: five males, mean age 57 years, disease onset 24 years. At OMA discontinuation, 88% were OCS-dependent with annual mean rate of 4.0 clinically significant exacerbations, 0.30 exacerbations needing emergency room visits or hospitalization; absenteeism due to disease was 10.4 days per patient. Switch to MEP improved all clinical outcomes, reducing total exacerbation rate (RR = 0.06, 95% CI 0.03–0.14), OCS-dependent patients (OR = 0.02, 95% CI 0.005–0.08), and number of lost working days (Δ = − 7.9, 95% CI − 11.2 to − 4.6). Pulmonary function improved, serum IgE, FeNO and eosinophils decreased. Mean annual costs were €12,239 for OMA and €12,639 for MEP (Δ = €400, 95% CI − 1588–2389); the increment due to drug therapy (+ €1,581) was almost offset by savings regarding all other cost items (− €1,181). Patients with severe eosinophilic asthma, not controlled by OMA, experienced comprehensive benefits by switching to MEP with only slight increases in economic costs.

Diagnosis and Management of Severe Asthma

2018 ◽  
Vol 39 (01) ◽  
pp. 091-099 ◽  
Author(s):  
Kian Fan Chung
Keyword(s):  
Severe Asthma ◽  
Inhaled Corticosteroids ◽  
Immunoglobulin E ◽  
High Dose ◽  
Blood Eosinophil ◽  
Exhaled Breath ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients ◽  
Long Acting

AbstractSevere therapy-resistant asthma has been defined as “asthma which requires treatment with high dose inhaled corticosteroids (ICSs) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy”. Patients who usually present with ‘difficult-to-treat asthma’ should first be assessed to determine whether he/she has asthma with the exclusion of other diagnoses and if so, whether the asthma can be classified as severe therapy-resistant. This necessitates an assessment of adherence to medications, confounding factors, and comorbidities. Increasingly, management of severe therapy-resistant asthma will be helped by the determination of phenotypes to optimize responses to existing and new therapies. Severe asthma patients are usually on a combination of high dose ICS and long-acting β-agonist (LABA) and, in addition, are often on a maintenance dose of oral corticosteroids. Phenotyping can be informed by measuring blood eosinophil counts and the level of nitric oxide in exhaled breath, and the use of sputum granulocytic counts. Severe allergic asthma and severe eosinophilic asthma are two defined phenotypes for which there are efficacious targeted biologic therapies currently available, namely anti-immunoglobulin E (IgE) and anti-interleukin (IL)-5 antibodies, respectively. Further progress will be realized with the definition of noneosinophilic or non-T2 phenotypes. It will be important for patients with severe asthma to be ultimately investigated and managed in specialized severe asthma centers.

scholarly journals Real-world study in severe eosinophilic asthma patients refractory to anti-IL5 biological agents treated with benralizumab in Spain (ORBE study)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva Martínez-Moragón ◽  
Ismael García-Moguel ◽  
Javier Nuevo ◽  
Gustavo Resler ◽  
Ignacio Antépara ◽  
...  
Keyword(s):  
Primary Care ◽  
Emergency Department ◽  
Emergency Department Visits ◽  
Severe Exacerbation ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients ◽  
The Difference

Abstract Background Benralizumab, a monoclonal antibody targeting the human interleukin-5 (IL-5) receptor (IL-5R), was used before marketing authorisation in Spain in a real world setting as part of an early-access programme (EAP) to treat patients with severe eosinophilic asthma with prior insufficient response or intolerance to anti-IL5 treatment (mepolizumab or reslizumab). The objective of this study is to describe the patient profile candidate for treatment and to assess benralizumab effectiveness. Methods This is an observational, retrospective, multicentre study in severe eosinophilic asthma patients refractory to other biological agents targeting the IL-5 pathway. Baseline characteristics included closest data, from the previous 12 months, to benralizumab treatment onset (index date). Patients were followed until the last treatment dosage while EAP was active (March to December 2018). Effectiveness was evaluated versus baseline, in patients who received at least three doses, with asthma control test (ACT), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), annual severe exacerbation rate, oral corticosteroids treatment (OCS) and asthma-related healthcare resources utilization. Results Twenty-seven patients treated with benralizumab were included in the analysis. Effectiveness was assessed in 19 patients. Both questionnaires showed clinically meaningful differences, i.e. ACT score ≥ 3 and MiniAQLQ score ≥ 0.5, compared with baseline [mean (SD), 3.3 (6.8) and 1.2 (1.9), respectively]. Patients treated with OCS decreased during follow-up from 88.9% (n = 24/27) at baseline to 78.9% (n = 15/19) and 31.6% (n = 6/19) had an OCS dose reduction ≥ 50%. The difference in annual severe exacerbation rate during follow-up showed a significant reduction vs. baseline (2.12 per patient-year, 95% CI 0.99–3.24, p = 0.002). The differences in annual rate of non-scheduled primary care and specialist visits during follow-up indicated a significant decrease [2.28 per patient-year (95% CI 1.55–3.01; p < 0.001) and 1.47 per patient-year (95% CI 0.65–2.30; p = 0.004), respectively], as well as the difference in annual rate of number of emergency department visits [1.18 per patient-year (95% CI 0.51–1.85; p = 0.007)]. Conclusions These results suggest that severe eosinophilic asthma patients receiving benralizumab, presented clinically meaningful improvement in asthma control and asthma-related QoL as well as OCS dose reduction. Results also aim to significant reductions in annual severe exacerbation rates, non-scheduled primary care and specialist visits, and emergency department visits rates.

Adherence to inhaled corticosteroids and clinical outcomes following a year of benralizumab therapy for severe eosinophilic asthma

Allergy ◽  
2021 ◽  
Author(s):  
Grainne d'Ancona ◽  
Joanne E. Kavanagh ◽  
Jaideep Dhariwal ◽  
Andrew P. Hearn ◽  
Cris Roxas ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Inhaled Corticosteroids ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma

scholarly journals Regulatory T cell monitoring in severe eosinophilic asthma patients treated with mepolizumab

2021 ◽  
Author(s):  
Laura Bergantini ◽  
Miriana d’Alessandro ◽  
Paolo Cameli ◽  
Clara Bono ◽  
Marco Perruzza ◽  
...  
Keyword(s):  
T Cell ◽  
Regulatory T Cell ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients ◽  
Cell Monitoring

scholarly journals Basophil activation and serum IL‐5 levels as possible monitor biomarkers in severe eosinophilic asthma patients treated with anti‐IL‐5 drugs

Allergy ◽  
2020 ◽  
Author(s):  
Cristiano Caruso ◽  
Stefania Colantuono ◽  
Barbara Tolusso ◽  
Clara Di Mario ◽  
Antonella Pentassuglia ◽  
...  
Keyword(s):  
Basophil Activation ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients

scholarly journals Clinical and Economic Consequences of Switching From Omalizumab to Mepolizumab in Uncontrolled Severe Eosinophilic Asthma: an Observational Retrospective Study

2020 ◽  
Author(s):  
Giovanna Elisiana Carpagnano ◽  
Emanuela Resta ◽  
Massimiliano Povero ◽  
Corrado Pelaia ◽  
Mariella D'Amato ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Asthma Control ◽  
Exhaled Nitric Oxide ◽  
Blood Eosinophil ◽  
Fractional Exhaled Nitric Oxide ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Serum Ige ◽  
Severe Eosinophilic Asthma ◽  
Oral Corticosteroids

Abstract Background: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids, which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab to mepolizumab in patients eligible for both biologics, but not optimally controlled by omalizumab.Methods: We retrospectively enrolled uncontrolled severe asthmatic patients, referred to seven asthma clinics in Italy, who switched from omalizumab to mepolizumab during the last two years. Clinical, functional, and laboratory information included blood eosinophil count, asthma control test, spirometry, serum IgE, fractional exhaled nitric oxide, oral corticosteroids intake, use of controller and rescue drugs, exacerbations/hospitalizations, visits and diagnostic exams. Within the perspective of Italian National Health System, a pre- and post-mepolizumab 12-month standardized total cost per patient was calculated.Results: 33 patients were enrolled: 5 males and 28 females, mean age 57 years, mean disease onset 24 years. At omalizumab discontinuation, 88% were oral corticosteroids-dependent with annual mean rate of 4.0 clinically significant exacerbations, 0.30 exacerbations needing emergency room visits or hospitalization; absenteeism due to disease was 10.4 days per patient. Switch to mepolizumab improved all clinical outcomes, reducing total exacerbation rate (RR = 0.06, 95% CI 0.03 to 0.14), oral corticosteroids -dependent patients (OR = 0.02, 95% CI 0.005 to 0.08), and the number of lost working days because of uncontrolled disease (Δ = -7.9, 95% CI -11.2 to -4.6). Pulmonary function improved, as well as serum IgE, fractional exhaled nitric oxide and eosinophils decreased. Mean annual costs were € 12,239 for omalizumab and € 12,639 for mepolizumab (Δ = € 400, 95% CI -1,588 to 2,389); the increment due to drug therapy (+ € 1,581) was almost offset by savings regarding all other cost items (- € 1,181). Conclusions: Patients with severe eosinophilic asthma, not controlled by omalizumab, experienced comprehensive benefits in asthma control by switching to mepolizumab. These relevant improvements were burdened by only very slight increases in economic costs.

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