Alalia Berry, MD, William W. Busse, MD

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Biomarkers in asthmatic patients: Has their time come to direct treatment? Alalia Berry, MD, William W. Busse, MD Journal of Allergy and Clinical Immunology Volume 137, Issue 5, Pages 1317-1324 (May 2016) DOI: 10.1016/j.jaci.2016.03.009 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Potential biomarkers in relationship to asthma, beginning with prenatal risk for disease and extending to markers associated with treatment selection. Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Severe exacerbations during the course of the study comparing placebo versus mepolizumab. The cumulative number of severe exacerbations that occurred in each study group over the course of 50 weeks is shown. Reprinted with permission from Haldar et al.20 Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Responsiveness of TH2-high asthma to ICSs and reproducibility of phenotypic markers after placebo in a randomized controlled trial. FEV1 was measured at baseline (week 0), after 4 and 8 weeks of daily fluticasone (500 mg twice daily), and 1 week after the cessation of fluticasone (week 9). There was no significant change in FEV1 in response to placebo at any time point in either group. Reprinted with permission of the American Thoracic Society (Copyright ©2016 American Thoracic Society) from Woodruff et al.49 *P < .05. Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Relative change in FEV1 in the intention-to-treat population. At week 12, the increase from baseline in FEV1 was higher by 5.5 percentage points (95% CI, 0.8-10.2 percentage points) in the lebrikizumab group than in the placebo group (mean ± SE change, 9.8% ± 1.9% vs 4.3% ± 1.5%; P = .02; A). In the subgroup of patients with high periostin levels, the relative increase from baseline FEV1 was higher by 8.2 percentage points (95% CI, 1.0-15.4 percentage points) in the lebrikizumab group than in the placebo group (mean change, 14.0% ± 3.1% vs 5.8% ± 2.1%; P = .03; B). Among patients in the subgroup with low periostin levels, the relative increase from baseline FEV1 was higher by 1.6 percentage points (95% CI, −4.5 to 7.7 percentage points) in the lebrikizumab group than in the placebo group (mean change, 5.1% ± 2.4% vs 3.5% ± 2.1%; P = .61; C). Reprinted with permission from Corren et al.52 Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Peripheral blood periostin levels differentiate patients with severe uncontrolled asthma taking high-dose ICSs according to airway eosinophilic inflammation, as measured in sputum and dichotomized by sputum eosinophilia. Reprinted with permission from Jia et al.54 Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 6 Peripheral blood periostin levels differentiate patients with severe uncontrolled asthma taking high-dose ICSs according to airway eosinophilic inflammation. The composite airway eosinophil score (sputum and biopsy eosinophil counts at 2 cut pointed) demonstrating a strong positive progression of increasing serum periostin levels with increasing scores is shown (P < .002, logistic regression). Bx, Biopsy. Reprinted with permission from Jia et al.54 Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 7 Mean percentage reduction (95% CI) in protocol-defined asthma exacerbation rate in the low-level and high-level biomarker subgroups (baseline Feno values, peripheral blood eosinophil counts, and serum periostin levels). *Exacerbation reduction P values; omalizumab versus placebo in each biomarker subgroup. Reprinted with permission of the American Thoracic Society (Copyright ©2016 American Thoracic Society) from Hanania et al.28 Journal of Allergy and Clinical Immunology 2016 137, 1317-1324DOI: (10.1016/j.jaci.2016.03.009) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions