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Eur Respir J. 2018 May 10;51(5). pii: 1702523. doi: 10.1183/13993003.02523-2017. Print 2018 May.

Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study.

Author information

1
Université Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.
2
AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
3
INSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.
4
AP-HP, Hôpital Bichat, Service de Pneumologie et Centre de Référence des Maladies Pulmonaires Rares, Dépt Hospitalo-Universitaire FIRE, Université Paris Diderot, INSERM UMR 1152, Paris, France.
5
Novartis Pharma SAS, Rueil-Malmaison, France.
6
Université Paris Sorbonne, AP-HP, Service d'Allergologie Pédiatrique (Centre de l'Asthme), Hôpital Trousseau, Paris, France.
7
Dept of Medical Pharmacology, Université de Bordeaux, INSERM UMR 1219, Bordeaux, France.

Abstract

Omalizumab is a monoclonal anti-IgE antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count as a predictive measure for response to omalizumab.This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate and a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6-17 years)). Blood eosinophil count was ≥300 cells·µL-1 in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a ≥40% reduction in the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2-63.4%) for blood eosinophils ≥300 cells·µL-1 (n=377) and 58.1% (95% CI 52.7-63.4%) for blood eosinophils <300 cells·µL-1 (n=346).This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL-1, and suggests that omalizumab effectiveness is similar in "high" and "low" eosinophil subgroups.

PMID:
29545284
DOI:
10.1183/13993003.02523-2017
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Conflict of interest statement

Conflict of interest: M. Humbert has relationships with drug companies including AstraZeneca, GSK, Novartis, Roche, Sanofi/Regeneron and Teva. In addition to being an investigator in trials involving these companies, relationships include consultancy services and membership of scientific advisory boards. C. Taillé received personal fees from Kappa Santé, during the conduct of the study; and received personal fees from and acted as a study investigator for AstraZeneca, Boehringer, Novartis and ALK, received personal fees from Chiesi and Teva, received grants and personal fees from and acted as a study investigator for GSK, and acted as a study investigator for Sanofi, outside the submitted work. L. Mala is an employee of Novartis Pharma SAS. V. Le Gros is an employee of Novartis Pharma SAS. J. Just received personal fees from ALK and Stallergenes, and grants and personal fees from Novartis, outside the submitted work. M. Molimard received personal fees from Novartis Pharma, GSK and Boehringer Ingelheim (for consulting agreement and participation on scientific advisory boards), and was employed by the University of Bordeaux, during the conduct of the study; and received an unconditional educational grant from Novartis Pharma, outside the submitted work.

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