Journal of Allergy and Clinical Immunology

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Presentation transcript:

Journal of Allergy and Clinical Immunology Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma Sumita Khatri, MD, Wendy Moore, MD, Peter G. Gibson, MD, Richard Leigh, MD, PhD, Arnaud Bourdin, MD, PhD, Jorge Maspero, MD, FCCP, Manuel Barros, MD, Roland Buhl, MD, PhD, Peter Howarth, BSc (Hons), MBBS, DM, FRCP, Frank C. Albers, MD, PhD, Eric S. Bradford, MD, Martyn Gilson, MSc, Robert G. Price, MSc, Steven W. Yancey, MSc, Hector Ortega, MD, ScD, FAAAAI Journal of Allergy and Clinical Immunology DOI: 10.1016/j.jaci.2018.09.033 Copyright © 2018 GlaxoSmithKline Terms and Conditions

Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig 1 Patient flow through the COLUMBA study. *After completion of COLUMBA, patients could enter a further mepolizumab study (201810 or 201956) or choose to receive mepolizumab commercially outside of a clinical trial. ITT, Intent-to-treat; IV, intravenous; SC, subcutaneous. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig 2 Time to study cessation. Study closure was conducted in a staged manner as mepolizumab became commercially available for prescription in each participating country. SC, Subcutaneous. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig 3 Summary of on-treatment AEs occurring in more than 10% of patients (A) and on-treatment SAEs occurring in more than 1 patient (as-treated population; B). *Respiratory tract infection encompasses all AEs reported as (1) viral upper respiratory tract infection; (2) upper respiratory tract infection; (3) respiratory tract infection; (4) lower respiratory tract infection; (5) respiratory tract infection, viral; (6) lower respiratory tract infection, viral; and (7) upper respiratory tract infection, bacterial. †One patient had a childhood history of epilepsy. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig 4 Summary of efficacy end points. A, Exacerbation rate per year across DREAM and COLUMBA. A total of 286 patients with 156 weeks or more of open-label data in COLUMBA are summarized (DREAM: placebo, n = 62; mepolizumab, n = 224). B, ACQ-5 score change from baseline. C, Prebronchodilator FEV1 change from baseline. D, Blood eosinophil geometric mean ratio to baseline. Pretreatment refers to the 12 months before enrollment in DREAM. ACQ-5 responders were defined as patients with a reduction in ACQ-5 score of 0.5 points or more from baseline. Vertical bars show 95% CIs. Minimum clinically important difference: ACQ-5, 0.5 points; FEV1, 100 mL. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig E1 Summary of on-treatment AEs occurring in more than 10% of patients (A) and on-treatment SAEs occurring in more than 1 patient by age of asthma onset (as-treated population; B). *AEs were listed in line with Fig 3. -, AEs that were not reported in these populations. †Respiratory tract infection encompasses all AEs reported as (1) viral upper respiratory tract infection; (2) upper respiratory tract infection; (3) respiratory tract infection; (4) lower respiratory tract infection; (5) respiratory tract infection, viral; (6) lower respiratory tract infection, viral; and (7) upper respiratory tract infection, bacterial. ‡One patient with early-onset asthma had a childhood history of epilepsy. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions

Fig E2 Annualized rate of on-treatment exacerbations by baseline blood eosinophil count. Journal of Allergy and Clinical Immunology DOI: (10.1016/j.jaci.2018.09.033) Copyright © 2018 GlaxoSmithKline Terms and Conditions