Dataset Information

Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma in Canada: an observational study.

ABSTRACT:

Background

Mepolizumab, the first widely available anti-interleukin 5 biologic, targets eosinophilic inflammation and has been shown in clinical trials to reduce exacerbations, oral corticosteroid dependence, and healthcare utilization in patients with severe asthma. The impact of mepolizumab in a real-world, publicly funded healthcare setting is unknown. The objective of this study was to describe the demographics and clinical characteristics of real-world patients receiving mepolizumab, and to compare asthma-related outcomes and associated asthma-related costs before and during mepolizumab use.

Methods

This retrospective, observational study in Ontario, Canada, included patients initiating mepolizumab between February 2016 and March 2019. Patients were identified using the mepolizumab patient support program and linked to the Institute for Clinical Evaluative Sciences database of publicly accessed healthcare. Patient outcomes were obtained for 12 months pre- and post-mepolizumab initiation and compared.

Results

A total of 275 patients were enrolled in the overall patient support program cohort (mean [standard deviation] age 57.6 [13.5] years, mean [standard deviation] of the median per-patient eosinophil count 540.4 [491.9] cells/μL). Mepolizumab was associated with reductions in asthma exacerbations (46.1%, P < 0.001) and in the number of asthma-related visits to general practitioners (40.2%, P < 0.001), specialists (27.2%, P < 0.001), and emergency departments (52.1%, P < 0.001). Associated costs were significantly lower post- versus pre-mepolizumab for asthma-related general practitioner and specialist visits, and for all-cause emergency department visits and hospital admissions.

Conclusions

In a real-world population of Canadian patients with severe asthma with an eosinophilic phenotype, the use of mepolizumab within a patient support program reduced asthma exacerbations and decreased asthma-related healthcare resource utilization and associated costs.

SUBMITTER: Chapman KR

PROVIDER: S-EPMC10838436 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Publications

Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma in Canada: an observational study.

Chapman Kenneth R KR Cogger Kathryn K Arthurs Erin E LaForty Callahan C Golden Shane S Millson Bradley B Usuba Koyo K Licskai Christopher C

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology 20240204 1

<h4>Background</h4>Mepolizumab, the first widely available anti-interleukin 5 biologic, targets eosinophilic inflammation and has been shown in clinical trials to reduce exacerbations, oral corticosteroid dependence, and healthcare utilization in patients with severe asthma. The impact of mepolizumab in a real-world, publicly funded healthcare setting is unknown. The objective of this study was to describe the demographics and clinical characteristics of real-world patients receiving mepolizumab ...[more]

PMID: 38311747

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Project description:PurposeImproved understanding of characteristics that may influence treatment response across phenotypes may help guide treatment decisions.Patients and methodsThis was a post hoc analysis of MENSA, a multicenter, randomized, double-blind, placebo-controlled trial (NCT01691521). Patients aged ≥12 years with severe eosinophilic asthma received mepolizumab (75 mg intravenously or 100 mg subcutaneously) or placebo, plus standard of care, every 4 weeks for 32 weeks. Outcomes assessed were the annualized rate of clinically significant exacerbations and change from baseline in Asthma Control Questionnaire (ACQ)-5 score. Subgroup analyses were performed by baseline blood eosinophil count (<150, ≥150-300, ≥300 cells/μL) within atopic subgroups (non-atopic [specific immunoglobulin E <0.35 kU/L], atopic [≥0.35-17.5 kU/L], strongly atopic [>17.5 kU/L]), and by house dust mite (HDM) sensitivity.ResultsOf 576 patients analyzed, 272 were non-atopic, 181 were atopic and 94 were strongly atopic; 29 had missing atopy data. In patients with blood eosinophil counts ≥300 cells/µL, mepolizumab versus placebo reduced clinically significant exacerbations by 74%, 43% and 25% in the non-atopic, atopic and strongly atopic subgroups. Similar reductions were observed in all atopic subgroups in other blood eosinophil count categories where there were sufficient patient numbers for analysis, except for non-atopic patients with baseline blood eosinophil counts of <150 cells/μL. Improvements in ACQ-5 scores of -0.75, -0.73 and -0.78 with mepolizumab versus placebo were observed in non-atopic, atopic and strongly atopic patients with blood eosinophil counts ≥300 cells/µL; consistent improvements in ACQ-5 were not observed in patients with blood eosinophil counts <150 or ≥150-300 cells/μL. Reductions in clinically significant exacerbations with mepolizumab versus placebo were also observed irrespective of sensitivity to HDMs.ConclusionMepolizumab was associated with a trend for reductions in clinically significant exacerbations and improved asthma control versus placebo in patients with severe eosinophilic asthma, irrespective of atopic status or HDM sensitivity.

Project description:BackgroundData on mepolizumab in patients with severe eosinophilic asthma (EA) and comorbidities are needed to assess whether randomized controlled trial results are applicable in the real world.ObjectiveTo evaluate real-life effectiveness and the presence/absence of predictors of treatment response in patients with one or more comorbidities (nasal polyps, allergic rhinitis, gastro-esophageal reflux disease, nonallergic rhinitis with eosinophilia syndrome, obesity, bronchiectasis) who received mepolizumab (MEPO) for the treatment of severe EA.MethodsWe performed a single-center retrospective study in patients with severe asthma and presence of comorbidities treated with mepolizumab at the respiratory outpatient clinic, Policlinico-Vittorio Emanuele, Catania, Italy. Health records of 31 severe asthmatic patients were retrieved and analyzed. Asthma control test (ACT) score, blood eosinophil count, forced expiratory volume in 1 s (FEV1), FEV1% of predicted and FEV1/FVC (Forced Vital Capacity) ratio, oral corticosteroid (OCS) dosage, and exacerbations were recorded at baseline (T0), after 3 (T1), 6 (T3), 9 (T6), and 12 months (T12). Clinical response was defined when 3 of these 4 criteria were fulfilled: i) 30% exacerbation decrease; ii) 80% blood eosinophilia reduction; iii) 3 point ACT increase; iv) FEV1 increase ≥200 mL.Results83.87% of patients were classified as responsive to MEPO treatment. Substantial depletion of the blood eosinophils (>80%) was found in 87.1% of patients, FEV1 > 200 mL was seen in 54.84% of patients, a 3-point ACT improvement from baseline was recorded in 80.65% 25 of patients and a 30% reduction of exacerbations rates was seen in 96.77% of patients. Moreover, the majority 38.71% of patients met 3/4 parameters after 12 months. Neither the comorbidities nor other characteristics (sex, BMI, age, smoking) influenced treatment response.ConclusionsMEPO in patients with severe EA is effective regardless of the presence of comorbidities.

Dataset Information

Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma in Canada: an observational study.

Background

Methods

Results

Conclusions

Publications

Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma in Canada: an observational study.

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