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.

Conflict of interest statement

Conflict of interest: C. Taillé reports that the study and manuscript preparation support was funded by GlaxoSmithKline; grants and personal fees for consultancy and lectures from GlaxoSmithKline, AstraZeneca, Novartis, Roche, Sanofi, Chiesi and TEVA, outside the submitted work. Conflict of interest: P. Chanez reports that the study and manuscript preparation support was funded by GlaxoSmithKline; personal fees for advisory board work from Almirall, grants and personal fees for lectures from Alk-Abello, Boston Scientific and Centocor, grants and personal fees for consultancy, advisory board work and lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis and Teva, personal fees for consultancy and advisory board work from Johnson & Johnson and Sanofi, personal fees for consultancy from Merck Sharp & Dohme, grants from Roche, outside the submitted work. Conflict of interest: G. Devouassoux reports that the study and manuscript preparation support was funded by GlaxoSmithKline; grants and personal fees for consultancy and meeting participation from Novartis Pharma, AstraZeneca, GlaxoSmithKline, ALK, TEVA, personal fees for consultancy and meeting participation from MundiPharma, grants and personal fees for consultancy from Boehringer Ingelheim, personal fees for consultancy from Vivisol, grants from Sanofi, Vitalair, AB Science, Amgen, Lilly and Roche, grants and personal fees for meeting participation from Chiesi and MSD, personal fees for meeting participation from AGIR a dom, Orkyn, Stallergene and Takeda, outside the submitted work. Conflict of interest: A. Didier reports that the study and manuscript preparation support was funded by GlaxoSmithKline; personal fees for consultancy and meeting participation from Novartis Pharma, AstraZeneca and GlaxoSmithKline, personal fees for consultancy from Chiesi, Boehringer Ingelheim, Mundi Pharma, TEVA, ALK and Menarini, outside the submitted work. Conflict of interest: C. Pison reports that the study and manuscript preparation support was funded by GlaxoSmithKline; grants, personal fees for lectures and non-financial support for meeting attendance from Novartis, AstraZeneca, GlaxoSmithKline, Chiesi, Boehringer Ingelheim and Sanofi, grants and personal fees for consultancy and lectures from Mundi Pharma and MSD, outside the submitted work. Conflict of interest: G. Garcia reports that the study and manuscript preparation support was funded by GlaxoSmithKline; personal fees for advisory board work from Novartis and Sanofi, personal fees for advisory board work and consultancy from AstraZeneca, personal fees for consultancy from GlaxoSmithKline, non-financial support for travel from Oxyvie, outside the submitted work. Conflict of interest: J. Charriot reports that the study and manuscript preparation support was funded by GlaxoSmithKline. Conflict of interest: S. Bouée reports that the study and manuscript preparation support was funded by GlaxoSmithKline; is an employee of CEMKA, and reports grants from GlaxoSmithKline, outside the submitted work. Conflict of interest: A. Gruber reports that the study and manuscript preparation support was funded by GlaxoSmithKline; and is an employee and shareholder of GlaxoSmithKline, outside the submitted work. Conflict of interest: C. Pribil reports that the study and manuscript preparation support was funded by GlaxoSmithKline; and is an employee and shareholder of GlaxoSmithKline, outside the submitted work. Conflict of interest: A. Bourdin reports that the study and manuscript preparation support was funded by GlaxoSmithKline; personal fees for clinical trial work from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Chiesi, Novartis and Sanofi, outside the submitted work. Conflict of interest: M. Humbert reports that the study and manuscript preparation support was funded by GlaxoSmithKline; personal fees for consultancy, speaking at conferences, and participation in clinical research projects from AstraZeneca, GlaxoSmithKline, Novartis, Roche, Sanofi and TEVA, outside the submitted work.

Copyright ©ERS 2020.

Figures

FIGURE 1

a) Change in mean oral corticosteroid (OCS) dose and b) proportion of patients not receiving maintenance OCS during follow-up period. #: mg prednisolone equivalent. At baseline, eight patients had missing data. At months 12 and 24 of follow-up, 42 and 31 patients had discontinued treatment, and eight and 40 had no follow-up, respectively.

FIGURE 2

a) Evolution of percent-predicted pre-bronchodilator forced expiratory volume in 1 s (FEV1) b) FEV1/ forced vital capacity (FVC) ratio and c) Asthma Control Test (ACT) score during the follow-up period. Continuous lines represent evolution of each score; dotted lines indicate the confidence interval.

FIGURE 3

Evolution of eosinophil counts during the follow-up period. Continuous lines represent evolution of each score; dotted lines indicate the confidence interval.