The members of the CRISALIS/ F-CRIN network contributed to obtaining "real-life" data of dupilumab in France as part of the French program of early access to use (Temporary Authorization of Nominal Use, ATUn) for uncontrolled severe asthma patients with no available treatment option left. The use of dupilumab in this indication was then validated by the European Commission in March 2019.
The results were published in May in the « Clinical & Experimental Allergy" journal.
Effectiveness and safety of dupilumab for the treatment of severe asthma in a real‐life French multi‐centre adult cohort. Clin Exp Allergy. 2020 May 29. doi:10.1111/cea.13614. Online ahead of print. PMID: 32469092
Co-auteurs : Clairelyne Dupin, Drifa Belhadi, Laurent Guilleminault, Anne‐Sophie Gamez, Patrick Berger, Frédéric De Blay, Philippe Bonniaud, Christophe Leroyer, Guillaume Mahay, Pierre‐Olivier Girodet, Chantal Raherison, Stéphanie Fry, Geneviève Le Bourdellès, Alain Proust, Lise Rosencher, Gilles Garcia, Arnaud Bourdin, Cécile Chenivesse, Alain Didier, Camille Couffignal, Camille Taillé
Background : Dupilumab is a monoclonal anti‐IL‐4Rα antibody developed for the treatment of severe asthma (SA). An early access programme for dupilumab was opened in France in SA patients experiencing unacceptable steroids side‐effects and/or life‐threatening exacerbations.
Objective : To assess changes in asthma control between baseline and 12 months of treatment.
Methods : Multi‐centre (n = 13) retrospective real‐life cohort study. This study is registered on ClinicalTrials.gov (NCT04022447).
Results : Overall, 64 patients with SA (median age 51, interquartile range [44‐61]; 53% females) received dupilumab as add‐on therapy to maximal standard of care; and 76% were on oral daily steroids at baseline. After 12 months, median asthma control test score improved from 14 [7‐16] to 22 [17‐24] (P < .001); median forced expiratory volume in 1 seconds increased from 58% [47‐75] to 68% [58‐88] (P = .001); and daily prednisone dose was reduced from 20 [10‐30] to 5 [0‐7] mg/d (P < .001). Annual exacerbations decreased from 4 [2‐7] to 1 [0‐2] (P < .001). Hypereosinophilia ≥1500/mm3 was observed at least once during follow‐up in 16 patients (25%), persisting after 6 months in 8 (14%) of them. Increase in blood eosinophil count did not modify the clinical response during the study period. Injection‐site reaction was the most common side effect (14%). Three deaths were observed, none related to treatment by investigators.
Conclusion & clinical relevance : In this first real‐life cohort study of predominantly steroid‐dependent SA, dupilumab significantly improved asthma control and lung function and reduced oral steroids use and exacerbations rate. Despite limitations due to the retrospective study, these results are consistent with controlled trials efficacy data. Further studies are required to assess the clinical significance and long‐term prognosis of sustained dupilumab‐induced hypereosinophilia.
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