Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO

References

• Brightling CE, Monteiro W, Ward R, et al. Sputum eosinophilia and short-term response to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2000;356(9240):1480–1485. doi:10.1016/S0140-6736(00)02872-5
   PubMed Web of Science ®Google Scholar
• Saha S, Brightling CE. Eosinophilic airway inflammation in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):39–47. doi:10.2147/copd.2006.1.1.39
   PubMedGoogle Scholar
• Bafadhel M, McKenna S, Terry S, et al. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011;184(6):662–671. doi:10.1164/rccm.201104-0597OC
   PubMed Web of Science ®Google Scholar
• Bafadhel M, McCormick M, Saha S, et al. Profiling of sputum inflammatory mediators in asthma and chronic obstructive pulmonary disease. Respiration. 2012;83(1):36–44. doi:10.1159/000330667
   PubMed Web of Science ®Google Scholar
• Bartoli ML, Costa F, Malagrino L, et al. Sputum inflammatory cells in COPD patients classified according to GOLD 2011 guidelines. Eur Repir J. 2016;47(3):978–980. doi:10.1183/13993003.00784-2015
   PubMed Web of Science ®Google Scholar
• Brightling CE, McKenna S, Hargadon B, et al. Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease. Thorax. 2005;60(3):193–198. doi:10.1136/thx.2004.032516
   PubMed Web of Science ®Google Scholar
• Singh D, Kolsum U, Brightling CE, et al. Eosinophilic inflammation in COPD: prevalence and clinical characteristics. Eur Respir J. 2014;44(6):1697–1700. doi:10.1183/09031936.00162414
   PubMed Web of Science ®Google Scholar
• Kolsum U, Damera G, Pham TH, et al. Pulmonary inflammation in patients with chronic obstructive pulmonary disease with higher blood eosinophil counts. J Allergy Clin Immunol. 2017;140(4):1181–1184.e1187. doi:10.1016/j.jaci.2017.04.027
   PubMed Web of Science ®Google Scholar
• Bafadhel M, McKenna S, Pickering S, et al. The sensitivity and specificity of peripheral blood eosinophilia to predict sputum eosinophilia in COPD subjects. Am J Respir Crit Care Med. 2009;129:A1479.
   Google Scholar
• Negewo NA, McDonald VM, Baines KJ, et al. Peripheral blood eosinophils: a surrogate marker for airway eosinophilia in stable COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:1495–1504. doi:10.2147/COPD.S100338
   PubMed Web of Science ®Google Scholar
• Pignatti P, Visca D, Cherubino F, et al. Do blood eosinophils strictly reflect airway inflammation in COPD? Comparison with asthmatic patients. Respir Res. 2019;20(1):145. doi:10.1186/s12931-019-1111-1
   PubMed Web of Science ®Google Scholar
• Bafadhel M, McKenna S, Terry S, et al. Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Am J Respir Crit Care Med. 2012;186(1):48–55. doi:10.1164/rccm.201108-1553OC
   PubMed Web of Science ®Google Scholar
• Pascoe S, Locantore N, Dransfield MT, Barnes NC, Pavord I. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015;3(6):435–442. doi:10.1016/S2213-2600(15)00106-X
   PubMed Web of Science ®Google Scholar
• Pavord ID, Agusti A. Blood eosinophil count: a biomarker of an important treatable trait in patients with airway disease. Eur Respir J. 2016;47(5):1299–1303. doi:10.1183/13993003.00055-2016
   PubMed Web of Science ®Google Scholar
• Varricchi G, Bagnasco D, Borriello F, Heffler E, Canonica GW. Interleukin-5 pathway inhibition in the treatment of eosinophilic respiratory disorders: evidence and unmet needs. Curr Opin Allergy Clin Immunol. 2016;16(2):186–200. doi:10.1097/ACI.0000000000000251
   PubMed Web of Science ®Google Scholar
• Hartl S, Breyer MK, Burghuber OC, et al. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J. 2020;55(5):1901874. doi:10.1183/13993003.13901874-13992019.
   PubMed Web of Science ®Google Scholar
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651–659. doi:10.1016/S0140-6736(12)60988-X
   PubMed Web of Science ®Google Scholar
• Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390–400. doi:10.1016/S2213-2600(17)30125-X
   PubMed Web of Science ®Google Scholar
• Ortega HG, Yancey SW, Mayer B, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4(7):549–556. doi:10.1016/S2213-2600(16)30031-5
   PubMed Web of Science ®Google Scholar
• Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198–1207. doi:10.1056/NEJMoa1403290
   PubMed Web of Science ®Google Scholar
• Yancey SW, Ortega HG, Keene ON, et al. Meta-analysis of asthma-related hospitalization in mepolizumab studies of severe eosinophilic asthma. J Allergy Clin Immunol. 2017;139(4):1167–1175.e1162. doi:10.1016/j.jaci.2016.08.008
   PubMed Web of Science ®Google Scholar
• Chapman KR, Bergeron C, Bhutani M, et al. Do we know the minimal clinically important difference (MCID) for COPD exacerbations? COPD. 2013;10(2):243–249. doi:10.3109/15412555.2012.733463
   PubMedGoogle Scholar
• Dasgupta A, Kjarsgaard M, Capaldi D, et al. A pilot randomised clinical trial of mepolizumab in COPD with eosinophilic bronchitis. Eur Respir J. 2017;49(3):1602486. doi:10.1183/13993003.13902486-13992016.
   PubMed Web of Science ®Google Scholar
• Celli BR, MacNee W. ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004;23(6):932–946. doi:10.1183/09031936.04.00014304
   PubMed Web of Science ®Google Scholar
• Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398–404. doi:10.1183/09031936.02.00063702
   PubMed Web of Science ®Google Scholar
• Kon SS, Canavan JL, Jones SE, et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014;2(3):195–203. doi:10.1016/S2213-2600(14)70001-3
   PubMed Web of Science ®Google Scholar
• Yun JH, Lamb A, Chase R, et al. Blood eosinophil count thresholds and exacerbations in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2018;141(6):2037–2047.e2010. doi:10.1016/j.jaci.2018.04.010
   PubMed Web of Science ®Google Scholar
• Zeiger RS, Tran TN, Butler RK, et al. Relationship of Blood Eosinophil Count to Exacerbations in Chronic Obstructive Pulmonary Disease. J Allergy Clin Immunol in Practice. 2018;6(3):944–954.e945. doi:10.1016/j.jaip.2017.10.004
   PubMed Web of Science ®Google Scholar
• Criner GJ, Celli BR, Singh D, et al. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020;8(2):158–170. doi:10.1016/S2213-2600(19)30338-8
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Calverley PM, Seemungal TA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177(1):19–26. doi:10.1164/rccm.200707-973OC
   PubMed Web of Science ®Google Scholar
• Vestbo J, Anderson JA, Brook RD, et al. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016;387(10030):1817–1826. doi:10.1016/S0140-6736(16)30069-1
   PubMed Web of Science ®Google Scholar
• Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356(8):775–789. doi:10.1056/NEJMoa063070
   PubMed Web of Science ®Google Scholar
• Dransfield MT, Bourbeau J, Jones PW, et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013;1(3):210–223. doi:10.1016/S2213-2600(13)70040-7
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4):438–446. doi:10.1164/rccm.201703-0449OC
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med. 2016;374(23):2222–2234. doi:10.1056/NEJMoa1516385
   PubMed Web of Science ®Google Scholar
• Vestbo J, Leather D, Diar Bakerly N, et al. Effectiveness of fluticasone furoate-vilanterol for COPD in clinical practice. N Engl J Med. 2016;375(13):1253–1260. doi:10.1056/NEJMoa1608033
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnhart F, Brealey N, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378(18):1671–1680. doi:10.1056/NEJMoa1713901
   PubMed Web of Science ®Google Scholar
• Kerwin E, Hebert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012;40(5):1106–1114. doi:10.1183/09031936.00040712
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209. doi:10.1016/S2213-2600(13)70052-3
   PubMed Web of Science ®Google Scholar
• Morishita-Katsu M, Nishimura K, Taniguchi H, et al. The COPD assessment test and St George’s Respiratory Questionnaire: are they equivalent in subjects with COPD? Int J Chron Obstruct Pulmon Dis. 2016;11:1543–1551. doi:10.2147/COPD.S104947
   PubMed Web of Science ®Google Scholar
• Tsiligianni IG, Alma HJ, de Jong C, et al. Investigating sensitivity, specificity, and area under the curve of the Clinical COPD Questionnaire, COPD Assessment Test, and Modified Medical Research Council scale according to GOLD using St George’s Respiratory Questionnaire cutoff 25 (and 20) as reference. Int J Chron Obstruct Pulmon Dis. 2016;11:1045–1052. doi:10.2147/COPD.S99793
   PubMed Web of Science ®Google Scholar
• Vestbo J, Anderson JA, Calverley PM, et al. Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study. Clin Respir J. 2011;5(1):44–49. doi:10.1111/j.1752-699X.2010.00198.x
   PubMed Web of Science ®Google Scholar
• Terzikhan N, Verhamme KM, Hofman A, Stricker BH, Brusselle GG, Lahousse L. Prevalence and incidence of COPD in smokers and non-smokers: the Rotterdam Study. Eur J Epidemiol. 2016;31(8):785–792. doi:10.1007/s10654-016-0132-z
   PubMed Web of Science ®Google Scholar