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Observational Study
. 2018 May 10;51(5):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

Marc Humbert  1   2   3 , Camille Taillé  4 , Laurence Mala  5 , Vincent Le Gros  5 , Jocelyne Just  6 , Mathieu Molimard  7 ; STELLAIR investigators
Collaborators, Affiliations
Observational Study

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

Marc Humbert et al. Eur Respir J. .

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.

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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.

Figures

FIGURE 1
FIGURE 1
Study flowchart. T0: omalizumab treatment initiation; T4–6: first effectiveness assessment after 4–6 months of treatment; T12: effectiveness assessment at 12 months following treatment initiation.
FIGURE 2
FIGURE 2
Global Evaluation of Treatment Effectiveness evaluation at T4–6 (time of first effectiveness assessment after 4–6 months of treatment) by age group: minors (age 6–17 years; n=149) and adults (age ≥18 years; n=723). Error bars indicate 95% confidence intervals.
FIGURE 3
FIGURE 3
Responders to omalizumab treatment in adults (≥18 years) at T4–6 (time of first effectiveness assessment after 4–6 months of treatment) according to blood eosinophil count cut-off at 150 cells·µL−1 (“EOS 150”: <150 cells·µL−1, n=163; ≥150 cells·µL−1, n=560) and 300 cells·µL−1 (“EOS 300”: <300 cells·µL−1, n=346; ≥300 cells·µL−1, n=377). GETE: Global Evaluation of Treatment Effectiveness. a) Responders based on physician's global evaluation (GETE). b) Responders based on a ≥40% decrease in the annual exacerbation rate. c) Combined responders (combination of GETE and exacerbation rate decrease). Error bars indicate 95% confidence intervals.
FIGURE 4
FIGURE 4
Combined responders to omalizumab treatment in adults (≥18 years) according to the distribution of blood eosinophil count in the whole population.
FIGURE 5
FIGURE 5
Reduction in asthma exacerbation rate according to blood eosinophil count (cut-off 300 cells·µL−1 (“EOS 300”)) and serum IgE (cut-off 75 IU·µL−1) in adults (≥18 years) with severe allergic asthma.
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References

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