2020/04 - CRISALIS Publication - #mepolizumab #eosinophilic severe asthma #national early access program

The members of the CRISALIS/ F-CRIN network contributed to obtaining "real-life" data of mepolizumab in France as part of the French program of early access to use (Temporary Authorization of Nominal Use, nATU) for severe asthmatics eosinophils, pre-market program.


The results were published in April in the journal of the European Respiratory Society (ERS) "European respiratory journal".

Co-authors: Camille Taillé, Pascal Chanez, Gilles Devouassoux, Alain Didier, Christophe Pison, Gilles Garcia, Jeremy Charriot, Stéphane Bouée, Alina Gruber, Celine Pribil, Arnaud Bourdin, Marc Humbert
  • Abstract (avalaible on PubMed)

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.