Abstract
Background Mepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative 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/patient/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/patient/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.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Prof Taillé reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; grants and personal fees from GlaxoSmithKline, grants and personal fees from Astrazeneca, grants and personal fees from Novartis, grants and personal fees from Roche, grants and personal fees from Sanofi, grants and personal fees from Chiesi, grants and personal fees from TEVA, outside the submitted work.
Conflict of interest: Prof. Chanez reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from Almirall, grants and personal fees from Alk-Abello, grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Boston Scientific, grants and personal fees from Centocor, grants and personal fees from Chiesi, grants and personal fees from GSK, personal fees from Johnson & Johnson, personal fees from Merck Sharp & Dohme, grants and personal fees from Novartis, grants from Roche, personal fees from Sanofi, grants and personal fees from Teva, outside the submitted work.
Conflict of interest: Dr. Devouassoux reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; grants and personal fees from Novartis Pharma, grants and personal fees from Astrazeneca, grants and personal fees from GlaxoSmithKline, personal fees from MundiPharma, grants and personal fees from Bohringer Ingelheim, personal fees from Vivisol, grants from Sanofi, grants and personal fees from Chiesi, grants and personal fees from ALK, grants and personal fees from TEVA, grants and personal fees from MSD, personal fees from AGIR a dom, personal fees from Orkyn, personal fees from Stallergene, grants from Vitalair, grants from AB Science, grants from Amgen, grants from Lilly, grants from Roche, personal fees from Takeda, outside the submitted work.
Conflict of interest: Dr. Didier reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees from Novartis Pharma, personal fees from AstraZeneca, personal fees from GlaxoSmithKline, personal fees from Chiesi, personal fees from Boehringer Ingelheim, personal fees from Mundi Pharma, personal fees from TEVA, personal fees from ALK, personal fees from Menarini, outside the submitted work.
Conflict of interest: Dr. Pison reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; grants, personal fees and non-financial support from Novartis, grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from GlaxoSmithKline, grants, personal fees and non-financial support from Chiesi, grants, personal fees and non-financial support from Boehringer Ingelheim, grants and personal fees from Mundi Pharma, grants and personal fees from MSD, grants, personal fees and non-financial support from Sanofi, outside the submitted work.
Conflict of interest: Pr. Garcia reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees from Novartis, personal fees from AstraZeneca, personal fees from GlaxoSmithKline, non-financial support from Oxyvie, personal fees from Sanofi, outside the submitted work.
Conflict of interest: Dr. Charriot reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study.
Conflict of interest: Dr. Bouée reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees from CEMKA, grants from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Gruber reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees and other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Ms. Pribil reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees and other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Bourdin reports non-financial support from GlaxoSmithKline, other from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Chiesi, personal fees from Novartis, personal fees from Sanofi, outside the submitted work.
Conflict of interest: Prof. Humbert reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from AstraZeneca, grants and personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Roche, personal fees from Sanofi, personal fees from TEVA, outside the submitted work.
This is a PDF-only article. Please click on the PDF link above to read it.
- Received December 6, 2019.
- Accepted March 14, 2020.
- Copyright ©ERS 2020