scholarly journals Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study)

2021 ◽  
pp. 2100396
Author(s):  
Wendy C. Moore ◽  
Oliver Kornmann ◽  
Marc Humbert ◽  
Claude Poirier ◽  
Elisabeth H. Bel ◽  
...  
Keyword(s):  
Emergency Department ◽  
Asthma Control ◽  
Emergency Department Visit ◽  
Hazard Ratio ◽  
Blood Eosinophil ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Link Type ◽  
Clinically Significant

The long-term efficacy and safety of mepolizumab for treatment of severe eosinophilic asthma are well established. Here, we examine the clinical impact of stopping mepolizumab after long-term use.COMET (NCT02555371) was a randomised, double-blind, placebo-controlled, parallel-group, multicenter study. Patients who had completed COLUMBA (NCT01691859) or COSMEX (NCT02135692) and received continuous mepolizumab treatment for ≥3 years were randomised 1:1 to stop (switch to placebo) or continue subcutaneous mepolizumab 100 mg every 4 weeks for 52 weeks. Primary endpoint: time to first clinically significant exacerbation; secondary endpoints: time to first exacerbation requiring hospitalisation/emergency department visit, time to decrease in asthma control (≥0.5-point increase in Asthma Control Questionnaire-5 score from COMET baseline), and blood eosinophil count ratio to COMET baseline. Safety was assessed.Patients stopping (n=151) versus continuing (n=144) mepolizumab had significantly shorter times to first clinically significant exacerbation (hazard ratio: 1.61 [95% confidence interval: 1.17,2.22]; p=0.004) and decrease in asthma control (hazard ratio: 1.52 [1.13,2.02]; p=0.005), and higher blood eosinophil counts at Week 52 (270 versus 40 cells·µL−1; ratio [stopping versus continuing]: 6.19 [4.89, 7.83]; p<0.001). Differences in efficacy outcomes between groups were observed when assessed from Week 12 (16 weeks after last mepolizumab dose). Exacerbations requiring hospitalisation/emergency department visit were rare. Adverse events in patients continuing mepolizumab were consistent with previous studies. For patients who stopped mepolizumab, the safety profile was consistent with other eosinophilic asthma populations.Patients who stopped mepolizumab had an increase in exacerbations and reduced asthma control versus those who continued.

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.

scholarly journals Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial

2019 ◽  
Vol 5 (3) ◽  
pp. 00009-2019 ◽  
Author(s):  
Andrew Menzies-Gow ◽  
Jonathan Corren ◽  
Elisabeth H. Bel ◽  
Jorge Maspero ◽  
Liam G. Heaney ◽  
...  
Keyword(s):  
Adrenal Insufficiency ◽  
Asthma Control ◽  
Severe Asthma ◽  
Maintenance Phase ◽  
Phase Iii ◽  
Eosinophilic Asthma ◽  
Interleukin 5 ◽  
Severe Eosinophilic Asthma ◽  
Link Type ◽  
Related Quality

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody approved in several countries for the add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older. In the 28-week Phase III ZONDA trial (ClinicalTrials.gov identifier: NCT02075255), benralizumab produced a median 75% reduction from baseline in oral corticosteroid (OCS) dosage (versus 25% for placebo) while maintaining asthma control for patients with OCS-dependent severe asthma. This manuscript presents the detailed protocol for the Phase IIIb PONENTE (ClinicalTrials.gov identifier: NCT03557307), a study that will build on the findings from ZONDA.As the largest steroid-sparing study undertaken in severe asthma, PONENTE has a faster steroid tapering schedule for prednisone dosages ≥7.5 mg·day−1 than previous studies, and it includes an evaluation of adrenal insufficiency and an algorithm to taper OCS dosage when prednisone dosage is ≤5 mg·day−1. It also has a longer maintenance phase to assess asthma control for up to 6 months after completion of OCS tapering.The two primary endpoints are whether patients achieve 100% reduction in daily OCS use and whether patients achieve 100% reduction in daily OCS or achieve OCS dosage ≤5 mg·day−1, if adrenal insufficiency prevented further reduction, both sustained over ≥4 weeks without worsening of asthma. Safety and change from baseline in health-related quality of life will also be assessed.PONENTE should provide valuable guidance for clinicians on tapering OCS dosage, including the management of adrenal insufficiency, following benralizumab initiation for the treatment of patients who are OCS-dependent with severe, uncontrolled eosinophilic asthma.

scholarly journals Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Peter G. Gibson ◽  
Charlene M. Prazma ◽  
Geoffrey L. Chupp ◽  
Eric S. Bradford ◽  
Mark Forshag ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Asthma Control ◽  
Severe Asthma ◽  
Forced Expiratory Volume ◽  
Comorbid Conditions ◽  
Eosinophilic Asthma ◽  
Asthma Control Questionnaire ◽  
Severe Eosinophilic Asthma ◽  
St George's Respiratory Questionnaire ◽  
Clinically Significant

Abstract Background Comorbidities can complicate the management of severe asthma; therefore, the presence of comorbid conditions or traits often need to be considered when considering treatment options for patients with severe asthma. The aim of this analysis is to investigate the efficacy of mepolizumab in patients with severe eosinophilic asthma and comorbidities. Methods This was a post hoc analysis (GSK ID:209140) of data from the Phase IIb/III studies DREAM, MENSA, SIRIUS, and MUSCA. Patients aged ≥ 12 years with severe eosinophilic asthma were randomized to: mepolizumab 750, 250, or 75 mg intravenously or placebo (DREAM); mepolizumab 75 mg intravenously or 100 mg subcutaneously or placebo (MENSA); or mepolizumab 100 mg subcutaneously or placebo (SIRIUS and MUSCA) every 4 weeks for 24 weeks in SIRIUS and MUSCA, 32 weeks in MENSA or 52 weeks in DREAM. In this analysis the primary endpoint was the annual rate of clinically significant exacerbations; secondary endpoints were Asthma Control Questionnaire-5 score, St George’s Respiratory Questionnaire total score, and pre-bronchodilator forced expiratory volume in 1 s at study end. Subgroups were based on comorbidities at baseline. Results Overall, 1878 patients received placebo (n = 689) or mepolizumab (n = 1189). Across all comorbidity subgroups mepolizumab reduced the rate of clinically significant exacerbations by 44–68% versus placebo, improved Asthma Control Questionnaire-5 score by 0.27–0.59 points, and improved St George’s Respiratory Questionnaire total score by 5.0–11.6 points. Pre-bronchodilator forced expiratory volume in 1 s was improved by 27.1–286.9 mL in all but one comorbidity subgroup, the diabetes mellitus subgroup. Conclusions Mepolizumab reduces exacerbations, and improves asthma control, health-related quality of life, and lung function in patients with severe eosinophilic asthma despite comorbid conditions, including upper respiratory conditions, psychopathologies, cardiovascular conditions, gastroesophageal reflux disease, diabetes mellitus, and obesity. Trial registration: https://clinicaltrials.gov/ DREAM, MEA112997/NCT01000506; MENSA, MEA115588/NCT01691521; SIRIUS, MEA115575/NCT01842607; MUSCA, 200862/NCT02281318.

scholarly journals Mepolizumab improves sino-nasal symptoms and asthma control in severe eosinophilic asthma patients with chronic rhinosinusitis and nasal polyps: a 12-month real-life study

2021 ◽  
Vol 15 ◽  
pp. 175346662110093
Author(s):  
Aikaterini Detoraki ◽  
Eugenio Tremante ◽  
Maria D’Amato ◽  
Cecilia Calabrese ◽  
Claudia Casella ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Asthma Control ◽  
Real Life ◽  
Blood Eosinophil ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Nasal Symptoms ◽  
Asthma Patients ◽  
Nasal Cytology ◽  
Snot 22

Background: Severe eosinophilic asthma is frequently associated to chronic rhinosinusitis and nasal polyposis (CRSwNP) that contribute to poor asthma control. Mepolizumab is an anti-IL-5 monoclonal antibody, approved for the treatment of severe eosinophilic asthma. A limited number of studies have assessed the efficacy of mepolizumab on CRSwNP in severe asthmatics. We aim to evaluate the efficacy of mepolizumab on sino-nasal symptoms, polyp growth and asthma control in severe eosinophilic asthma patients with CRSwNP in real life. Methods: In this study 44 severe eosinophilic asthma patients with CRSwNP were treated with mepolizumab (100 mg q4w) for 1 year. The following outcomes were assessed before (T0), after 6 (T6) and 12 months (T12) of treatment: sino/nasal outcome test (SNOT-22), Total Endoscopic Nasal Polyp Score (TENPS), %FEV1 (FEV1/FEV1 predicted) and Asthma control test (ACT). Blood eosinophil count, exhaled nitric oxide (FENO) and prednisone intake were measured. In a subgroup of patients, nasal cytology was performed before (T0), after 6 (T6) and after 12 months (T12) of treatment with mepolizumab. Results: We reported a significant reduction of SNOT-22 [from 51.5 ± 21.2 at baseline (T0) to 31.70 ± 17.36 at T6 and 29.7 ± 21.5 at T12 (T0–T12 p < 0.001)] and a decrease of TENPS (from 2.88 ± 3.07 to 1.70 ± 2.37 and 1.77 ± 2.56 at T0, T6 and T12, respectively, T0–T12 p = 0.99). A significant improvement of %FEV1, ACT and a decrease in blood eosinophils and mean prednisone intake were also reported. No statistically significant decreasing trend was measured for FENO. Nasal cytology findings suggest a significant reduction of eosinophil percentage following mepolizumab treatment (from 16.8 ± 7.2% to 3.6 ± 6.2% and 0.8 ± 2.4% at T0, T6 and T12 respectively, T0 to T12: p < 0.001). Conclusions: Mepolizumab improves sino-nasal and asthma symptoms and reduces polyp growth in patients with severe eosinophilic asthma and concomitant CRSwNP in real life. The reviews of this paper are available via the supplemental material section.

scholarly journals Health outcomes after stopping long-term mepolizumab in severe eosinophilic asthma: COMET

2021 ◽  
pp. 00419-2021
Author(s):  
Mark C Liu ◽  
Elisabeth H Bel ◽  
Oliver Kornmann ◽  
Wendy C Moore ◽  
Norihiro Kaneko ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Healthcare Resource ◽  
Asthma Severity ◽  
Response To Therapy ◽  
Open Label ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Link Type ◽  
Increased Risk

AbstractAsthma worsening and symptom control are clinically important health outcomes in patients with severe eosinophilic asthma. This analysis of COMET evaluated whether stopping versus continuing long-term mepolizumab therapy impacted these outcomes.Patients with severe eosinophilic asthma with ≥3 years continuous mepolizumab treatment (via COLUMBA [NCT01691859] or COSMEX [NCT02135692] open label studies) were eligible to enter COMET (NCT02555371), a randomised, double-blind, placebo-controlled study. Patients were randomised 1:1 to continue mepolizumab 100 mg subcutaneous every four weeks or stop mepolizumab, plus standard of care asthma treatment. Patients could switch to open label mepolizumab following an exacerbation. Health outcome endpoints included time to first asthma worsening (composite endpoint: rescue use, symptoms, awakening at night and morning PEF), patient and clinician assessed global rating of asthma severity and overall perception of response to therapy, and unscheduled healthcare resource utilisation.Patients who stopped mepolizumab showed increased risk of and shorter time to first asthma worsening compared with those who continued mepolizumab (Hazard Ratio [HR]:1.71 [95% CI: 1.17 2.52] p=0.006), including reduced asthma control (increased risk of first worsening in rescue use [HR:1.36 (95% CI 1.00 1.84) p=0.047] and morning PEF [HR:1.77 (95% CI 1.21 2.59) p=0.003]). There was a higher probability of any unscheduled healthcare resource use (HR:1.81 [95% CI: 1.31 2.49]; p<0.001) and patients and clinicians reported greater asthma severity and less favourable perceived response to therapy for patients who stopped versus continued mepolizumab.These data suggest that patients with severe eosinophilic asthma continuing long-term mepolizumab treatment sustain clinically important improvements in health outcomes.

scholarly journals Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Catherine Lemiere ◽  
Camille Taillé ◽  
Jason Kihyuk Lee ◽  
Steven G. Smith ◽  
Stephen Mallett ◽  
...  
Keyword(s):  
Lung Function ◽  
Asthma Control ◽  
Clinical Characteristics ◽  
Meta Analysis ◽  
Phase Iii ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Clinically Significant ◽  
Post Hoc ◽  
Airway Reversibility

Abstract Background Severe asthma is associated with a broad range of phenotypes and clinical characteristics. This analysis assessed whether select baseline patient characteristics could prognosticate mepolizumab efficacy in severe eosinophilic asthma. Methods This was a post hoc meta-analysis of data from the Phase III MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862) studies. Patients aged ≥ 12 years with severe eosinophilic asthma and a history of exacerbations were randomised to receive placebo (MENSA/MUSCA), mepolizumab 75 mg intravenously (MENSA) or 100 mg subcutaneously (SC) (MENSA/MUSCA) every 4 weeks for 32 (MENSA) or 24 (MUSCA) weeks. The primary endpoint was the annual rate of clinically significant exacerbations; other outcomes included the proportion of patients with no exacerbations and changes from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV1), St George’s Respiratory Questionnaire (SGRQ) total score and Asthma Control Questionnaire (ACQ)-5 score. Analyses were performed by baseline age of asthma onset (< 18 years; 18–40 years; ≥ 40 years); lung function (% predicted FEV1 ≤ 60; 60–80; > 80); airway reversibility (reversible [≥ 12% change in FEV1]; non-reversible [< 12% change in FEV1]); perennial and/or seasonal allergen sensitivity (yes/no); asthma control (uncontrolled [ACQ-5 score ≥ 1.5]; partial/complete control [ACQ-5 score < 1.5]). Results Overall, 936 patients received mepolizumab 100 mg SC or placebo. Across age at asthma onset, lung function and airway reversibility subgroups, mepolizumab reduced the rate of clinically significant exacerbations by 49–63% versus placebo. Improvements in lung function, SGRQ total score and ACQ-5 score were also seen with mepolizumab versus placebo across most age and lung function subgroups. Clinically significant exacerbations were reduced with mepolizumab versus placebo irrespective of season or allergen sensitivity; SGRQ total and ACQ-5 scores were generally improved across seasons. Conclusions Mepolizumab efficacy was consistent for patients with varying age at asthma onset, lung function, airway reversibility and allergen sensitivities at baseline. Our results indicate that mepolizumab is likely to be beneficial for patients with severe eosinophilic asthma with a broad range of baseline clinical characteristics; large-scale real-world studies are needed to confirm the external validity of these findings. Trial registration Post hoc meta-analysis of data from MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862)

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.

scholarly journals Precision medicine applications for severe asthma

2019 ◽  
Vol 6 (4) ◽  
pp. 117-135
Author(s):  
Orit Gourgy Hacohen ◽  
Shai Cohen
Keyword(s):  
Precision Medicine ◽  
Severe Asthma ◽  
Oral Corticosteroid ◽  
Treatment Options ◽  
Current Evidence ◽  
Blood Eosinophil ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Beneficial Effects ◽  
New Treatment

Asthma is a heterogeneous condition in which multiple pathological pathways manifest with similar symptoms. Severe asthma (SA) is challenging to manage and comprises a significant health and economic burden. Many studies have been conducted in an attempt to define different clinical phenotypes that translate into biological endotypes, with the goal of tailoring treatment based on precision medicine. This review summarizes the current evidence for the treatments of SA, and in particular, the biologic treatments that are currently available: omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab. We found only limited high-quality direct evidence regarding treatment with anti-IgE (omalizumab) in SA patients. Data regarding anti-interleukin (IL)-5 (mepolizumab, reslizumab and benralizumab) showed beneficial effects in severe eosinophilic asthma (SEA) with different levels of blood eosinophils used in clinical trials. Dupilumab, anti-IL-4/IL-13, was shown to be effective in SEA and is the only agent currently FDA-approved for the indication of oral corticosteroid dependent asthma, regardless of the blood eosinophil level. This review also summarizes the existing knowledge regarding the characteristics of the patient who may respond to the different therapies. As of today, more studies are needed to better understand the diverse mechanisms that underlie SA phenotypes. We have not yet adequately reached the goal of precision medicine. Additional studies are necessary in order to find novel surrogate markers that can predict the response to a specific biologic therapy, especially in patients who are oral corticosteroid dependent. In addition, efforts must be invested into research looking for new treatment options for patients with non-type-2 inflammation SA. Statement of novelty: we review the current evidence regarding tailored treatment therapies in SA, with a particular focus on the knowledge regarding patient selection for specific biologic treatments.

Mepolizumab Is an Effective Option in Severe Eosinophilic Asthma Regardless of Baseline Features: Single-Center Real-Life Data

2021 ◽  
pp. 1-13
Author(s):  
Betül Özdel Öztürk ◽  
Zeynep Yavuz ◽  
Dilek Eraslan ◽  
Dilşad Mungan ◽  
Yavuz Selim Demirel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Blood Eosinophil ◽  
Life Questionnaire ◽  
Eosinophilic Asthma ◽  
Quality Of Life Questionnaire ◽  
Severe Eosinophilic Asthma ◽  
Median Dosage ◽  
Act Score

<b><i>Background:</i></b> Mepolizumab has been approved as a treatment option for severe eosinophilic asthma (SEA) patients in our country. We aimed to evaluate the clinical and functional efficacy of mepolizumab in this group of patients in real life as well as the response rates to mepolizumab and the possible factors affecting the response. <b><i>Methods:</i></b> The study was a retrospective chart review of patients with SEA treated with mepolizumab. The data were collected at baseline, and at the 6th and 12th month. <b><i>Results:</i></b> A total of 62 patients (41F/21M) with a mean age of 44.41 ± 13.24 years were included in the study. They had poor symptom control with a mean asthma control test (ACT) score of 16.61 ± 5.59, frequent exacerbations with a mean of 3.4 ± 3.7 in the previous 12 months, and 80.6% required daily oral corticosteroid (OCS) with a median dosage of 8 mg/day as methylprednisolone. The ACT score increased to 22.47 ± 3.18 and 22.03 ± 4.31, respectively, and blood eosinophil count decreased from 1,146/μL to 89/μL and 85/μL at the 6th and 12th month, respectively. The mean FEV1 at baseline was 2.102 L there was an increase of 0.373 L at 6th month and 0.596 L at 12th month. The percentage of regular users of OCS decreased to 66.0% at 6th month with a median dosage of 4 mg and 52.6% at 12th month with a median dosage of 2 mg. Mepolizumab reduced the rate of exacerbations compared with the previous year from a mean of 3.40 to 0.15 at 6th month and 0.36 at 12th month. There was a significant improvement in Asthma Quality of Life Questionnaire (AQLQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Sino-nasal Outcome Test (SNOT-22) scores at both of time points. The rate of responders and super-responders at 6th month was 60% and 28%, respectively, and consequently, the overall response rate was 88%. At the 12th month, the super-responder rate increased to 44.7% as well as the overall response to 89.4%. The only difference between the nonresponders, responders, and super-responders at the 6th and 12th month was whether regular daily OCS was used pre-mepolizumab. All nonresponders at both 6th and 12th month were using OCS regularly, whereas most of super-responder used the OCS only during exacerbations. <b><i>Conclusion:</i></b> Mepolizumab effectively reduced asthma exacerbations, steroid requirement, blood eosinophil counts and improved asthma control, pulmonary function, sinonasal symptoms and quality of life. Our data suggest that mepolizumab would be effective in selected patients in real-life settings.

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