Dataset Information

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

ABSTRACT:

Background

Mepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative autorisation temporaire d'utilisation [temporary use authorisation] (nATU)) before its commercialisation. This study aimed to characterise patients who received mepolizumab in the nATU.

Methods

This retrospective, observational study analysed data from the hospital medical records of patients up to 24?months after treatment initiation. Study objectives were to describe patient baseline characteristics, the evolution of disease severity and treatment modifications during follow-up; safety was also investigated.

Findings

Overall, 146 patients who received ?1 dose of mepolizumab were included. At inclusion, patients had a mean age of 58.2?years with a mean severe asthma duration of 13.4?years, and 37.0% had respiratory allergies. Patients experienced, on average, 5.8 exacerbations per patient per year at baseline, 0.6 and 0.5 of which required hospitalisation and emergency department visits, respectively. These values improved to 0.6, 0.1 and 0.1 exacerbations per patient per year, respectively, at 24?months of follow-up. Most patients (92.8%) were using oral corticosteroids at baseline, compared with 34.7% by 24?months of follow-up. Moreover, mean blood eosinophil counts improved from 722?cells·µL^-1 at baseline to 92?cells·µL^-1 at 24?months of follow-up; lung function and asthma control followed a similar trend.

Interpretation

Results confirm findings from clinical trials, demonstrating that mepolizumab is associated with important improvements in several clinically meaningful outcomes and has a favourable safety profile in a population with severe eosinophilic asthma, outside of the controlled environment of a clinical trial.

SUBMITTER: Taille C

PROVIDER: S-EPMC7315004 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

Taillé Camille C Chanez Pascal P Devouassoux Gilles G Didier Alain A Pison Christophe C Garcia Gilles G Charriot Jeremy J Bouée Stéphane S Gruber Alina A Pribil Celine C Bourdin Arnaud A Humbert Marc M

The European respiratory journal 20200625 6

<h4>Background</h4>Mepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative <i>autorisation temporaire d'utilisation</i> [temporary use authorisation] (nATU)) before its commercialisation. This study aimed to characterise patients who received mepolizumab in the nATU.<h4>Methods</h4>This retrospective, observational study analysed data from the hospital medical records of patients up to 24 months after treatment initiation. ...[more]

PMID: 32241829

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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.

Dataset Information

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

Background

Methods

Findings

Interpretation

Publications

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

Similar Datasets

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