Biomarkers for severe eosinophilic asthma

被引:205
作者
Yancey, Steven W. [1 ]
Keene, Oliver N. [3 ]
Albers, Frank C. [2 ]
Ortega, Hector [1 ]
Bates, Stewart [4 ]
Bleecker, Eugene R. [5 ]
Pavord, Ian [6 ,7 ]
机构
[1] GlaxoSmithKline, Resp Therapeut Area, Res Triangle Pk, NC USA
[2] GlaxoSmithKline, Resp Med Franchise, Res Triangle Pk, NC USA
[3] GlaxoSmithKline, Clin Stat, Stockley Pk, Uxbridge, Middx, England
[4] GlaxoSmithKline, Resp Discovery Med, Stevenage, Herts, England
[5] Univ Arizona, Coll Med, Div Genet Genom & Personalized Med, Tucson, AZ USA
[6] Univ Oxford, Resp Med Unit, Nuffield Dept Med, Oxford, England
[7] Univ Oxford, Oxford Resp BRC, Nuffield Dept Med, Oxford, England
关键词
Eosinophils; biomarkers; severe eosinophilic asthma; ANTI-IL-5 MEPOLIZUMAB THERAPY; OBSTRUCTIVE PULMONARY-DISEASE; SURROGATE END-POINTS; DOUBLE-BLIND; MONOCLONAL-ANTIBODY; SPUTUM EOSINOPHILIA; AIRWAY INFLAMMATION; PLACEBO; BENRALIZUMAB; MARKERS;
D O I
10.1016/j.jaci.2017.10.005
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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/mL or greater or a historical blood eosinophil threshold of 300 cells/mL 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.
引用
收藏
页码:1509 / 1518
页数:10
相关论文
共 76 条
[61]   Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab [J].
Pouliquen, Isabelle J. ;
Kornmann, Oliver ;
Barton, Sharon V. ;
Price, Jeffrey A. ;
Ortega, Hector G. .
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2015, 53 (12) :1015-1027
[62]  
Prazma C, 2017, AM J RESP CRIT CARE, V195
[63]   Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study [J].
Price, David B. ;
Rigazio, Anna ;
Campbell, Jonathan D. ;
Bleecker, Eugene R. ;
Corrigan, Christopher J. ;
Thomas, Mike ;
Wenzel, Sally E. ;
Wilson, Andrew M. ;
Small, Mary Buatti ;
Gopalan, Gokul ;
Ashton, Valerie L. ;
Burden, Anne ;
Hillyer, Elizabeth V. ;
Kerkhof, Marian ;
Pavord, Ian D. .
LANCET RESPIRATORY MEDICINE, 2015, 3 (11) :849-858
[64]   The interferon type I signature towards prediction of non-response to rituximab in rheumatoid arthritis patients [J].
Raterman, Hennie G. ;
Vosslamber, Saskia ;
de Ridder, Sander ;
Nurmohamed, Michael T. ;
Lems, Willem F. ;
Boers, Maarten ;
van de Wiel, Mark ;
Dijkmans, Ben A. C. ;
Verweij, Cornelis L. ;
Voskuyl, Alexandre E. .
ARTHRITIS RESEARCH & THERAPY, 2012, 14 (02)
[65]   Treatment of patients with the hypereosinophilic syndrome with mepolizumab [J].
Rothenberg, Marc E. ;
Klion, Amy D. ;
Roufosse, Florence E. ;
Kahn, Jean Emmanuel ;
Weller, Peter F. ;
Simon, Hans-Uwe ;
Schwartz, Lawrence B. ;
Rosenwasser, Lanny J. ;
Ring, Johannes ;
Griffin, Elaine F. ;
Haig, Ann E. ;
Frewer, Paul I. H. ;
Parkin, Jacqueline M. ;
Gleich, Gerald J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (12) :1215-1228
[66]   Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus [J].
Sacks, David B. ;
Arnold, Mark ;
Bakris, George L. ;
Bruns, David E. ;
Horvath, Andrea Rita ;
Kirkman, M. Sue ;
Lernmark, Ake ;
Metzger, Boyd E. ;
Nathan, David M. .
DIABETES CARE, 2011, 34 (06) :1419-1423
[67]   Heterogeneity of phenotypes in severe asthmatics. The Belgian Severe Asthma Registry (BSAR) [J].
Schleich, F. ;
Brusselle, G. ;
Louis, R. ;
Vandenplas, O. ;
Michils, A. ;
Pilette, C. ;
Peche, R. ;
Manise, M. ;
Joos, G. .
RESPIRATORY MEDICINE, 2014, 108 (12) :1723-1732
[68]   Anti-IL-5 (mepolizumab) therapy for eosinophilic esophagitis [J].
Stein, Miguel L. ;
Collins, Margaret H. ;
Villanueva, Joyce M. ;
Kushner, Jonathan P. ;
Putnam, Philip E. ;
Buckmeier, Bridget K. ;
Filipovich, Alexandra H. ;
Assa'ad, Amal H. ;
Rothenberg, Marc E. .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2006, 118 (06) :1312-1319
[69]   Anti-interleukin-5 antibody treatment (mepolizumab) in active eosinophilic oesophagitis: a randomised, placebo-controlled, double-blind trial [J].
Straumann, A. ;
Conus, S. ;
Grzonka, P. ;
Kita, H. ;
Kephart, G. ;
Bussmann, C. ;
Beglinger, C. ;
Smith, D. A. ;
Patel, J. ;
Byrne, M. ;
Simon, H-U .
GUT, 2010, 59 (01) :21-30
[70]  
Teva, 2016, RESL SUMM PROD CHAR