Reviews and feature article
Biomarkers for severe eosinophilic asthma

https://doi.org/10.1016/j.jaci.2017.10.005Get rights and content
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The last decade has seen the approval of several new biologics for the treatment of severe asthma-targeting specific endotypes and phenotypes. This review will examine how evidence generated from the mepolizumab clinical development program showed that blood eosinophil counts, rather than sputum or tissue eosinophil counts, evolved as a pharmacodynamic and predictive biomarker for the efficacy of treatment with mepolizumab in patients with severe eosinophilic asthma. Based on the available evidence and combined with clinical judgement, a baseline blood eosinophil threshold of 150 cells/μL or greater or a historical blood eosinophil threshold of 300 cells/μL or greater will allow selection of patients with severe eosinophilic asthma who are most likely to achieve clinically significant reductions in the rate of exacerbations with mepolizumab treatment.

Key words

Eosinophils
biomarkers
severe eosinophilic asthma

Abbreviations used

DREAM
Dose Ranging Efficacy and safety With Mepolizumab in Severe Asthma
Feno
Fraction of exhaled nitric oxide
GINA
Global Initiative for Asthma
ICS
Inhaled corticosteroid
MENSA
Mepolizumab Adjunctive Therapy in Subjects with Severe Uncontrolled Refractory Asthma
OCS
Oral corticosteroid
RR
Rate ratio
SIRIUS
Steroid Reduction with Mepolizumab Study

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This article reports data from studies funded by GlaxoSmithKline.

Disclosure of potential conflict of interest: S. W. Yancey, O. N. Keene, F. C. Albers, H. Ortega, and S. Bates are employees of GlaxoSmithKline and hold stock/shares in GlaxoSmithKline. E. R. Bleecker has performed clinical trials administered by his previous employer, Wake Forest School of Medicine, for AstraZeneca, MedImmune, Boehringer Ingelheim, Pfizer, Cephalon/Teva, Forest, Genentech, GlaxoSmithKline, Johnson & Johnson (Jansen), Novartis, and Sanofi and has also served as a paid consultant for AstraZeneca, MedImmune, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Forest, Novartis, Regeneron, and Sanofi. I. Pavord has received honoraria for speaking at sponsored meetings from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, and GlaxoSmithKline; received payment for organizing an educational event from AstraZeneca; received advisory board honoraria from Almirall, Genentech, Regeneron, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Schering-Plough, Novartis, Mylan Specialty (Dey Pharma), Napp Pharmaceuticals, and Respivert; and received sponsorship to attend international scientific meetings from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, and Napp Pharmaceuticals.