Mepolizumab for severe eosinophilic asthma (DREAM): A multicentre, double-blind, placebo-controlled trial

The Lancet

Volumn 380, Issue 9842, 2012, Pages 651-659

  Pavord, Ian D ^a   Korn, Stephanie ^b   Howarth, Peter ^c   Bleecker, Eugene R ^d   Buhl, Roland ^b   Keene, Oliver N ^e,f   Ortega, Hector ^g   Chanez, Pascal ^h  

^a UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^b UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^c SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

^d WAKE FOREST SCHOOL OF MEDICINE   (United States)

^e GLAXOSMITHKLINE   (United Kingdom)

^f GLAXOSMITHKLINE   (United States)

^g AIX MARSEILLE UNIVERSITY   (France)

^h HÔPITAL NORD   (France)

Author keywords

[No Author keywords available]

Indexed keywords

MEPOLIZUMAB;

ADULT; ARTICLE; ASTHMA; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DISEASE DURATION; DISEASE EXACERBATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EOSINOPHIL COUNT; FEMALE; FORCED EXPIRATORY VOLUME; GASTROINTESTINAL SYMPTOM; HEART DISEASE; HOSPITAL ADMISSION; HUMAN; INFECTION; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PEAK EXPIRATORY FLOW; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEVERE EOSINOPHILIC ASTHMA; SPIROMETRY; UNSPECIFIED SIDE EFFECT; UROGENITAL TRACT DISEASE; VASCULAR DISEASE;

EID: 84865145614     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)60988-X     Document Type: Article

References (28)

1. Global Initiative for Asthma. Global strategy for asthma management and prevention. http://www.ginasthma.org/guidelines-gina-report-global-strategy-for- asthma.html (accessed May 15, 2012).
2. Haldar P, Pavord ID, Shaw DE, et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 2008; 178: 218-24.
3. Flood-Page P, Menzies-Gow A, Phipps S, et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepithelial basement membrane of mild atopic asthmatics. J Clin Invest 2003; 112: 1029-36.
4. Flood-Page P, Swenson C, Faiferman I, et al. A study to evaluate safety and effi cacy of mepolizumab in patients with moderate persistent asthma. Am J Respir Crit Care Med 2007; 176: 1062-71.
5. Flood-Page PT, Menzies-Gow AN, Kay AB, Robinson DS. Eosinophil's role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med 2003; 167: 199-204.
6. Leckie MJ, ten Brinke A, Khan J, et al. Eff ects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet 2000; 356: 2144-48.
7. Haldar P, Brightling CE, Hargadon B, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009; 360: 973-84.
8. Nair P, Pizzichini MM, Kjarsgaard M, et al. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360: 985-93.
9. American Thoracic Society. Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. Am J Respir Crit Care Med 2000; 162: 2341-51.
10. Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999; 14: 902-07.
11. Juniper EF, Svensson K, Mork AC, Stahl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med 2005; 99: 553-58.
12. Juniper EF, Guyatt GH, Ferrie PJ, Griffi th LE. Measuring quality of life in asthma. Am Rev Respir Dis 1993; 147: 832-38.
13. Keene ON, Calverley PM, Jones PW, Vestbo J, Anderson JA. Statistical analysis of exacerbation rates in COPD: TRISTAN and ISOLDE revisited. Eur Respir J 2008; 32: 17-24.
14. Chanez P, Wenzel ES, Anderson PG, et al. Severe asthma in adults: what are the important questions? J Allergy Clin Immunol 2007; 119: 1337-48.
15. Romagnoli M, Caramori G, Braccioni F, et al. Near-fatal asthma phenotype in the ENFUMOSA Cohort. Clin Exp Allergy 2007; 37: 552-57.
16. Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J 1996; 9: 636-42.
17. Godard P, Chanez P, Siraudin L, Nicoloyannis N, Duru G. Costs of asthma are correlated with severity: a 1-yr prospective study. Eur Respir J 2002; 19: 61-67.
18. Djukanovic R, Wilson SJ, Kraft M, et al. Eff ects of treatment with antiimmunoglobulin E antibody omalizumab on airway infl ammation in allergic asthma. Am J Respir Crit Care Med 2004; 170: 583-93.
19. Corren J, Lemanske RF, Hanania NA, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011; 365: 1088-98.
20. Green RH, Brightling CE, McKenna S, et al. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet 2002; 360: 1715-21.
21. Jayaram L, Pizzichini MM, Cook RJ, et al. Determining asthma treatment by monitoring sputum cell counts: eff ect on exacerbations. Eur Respir J 2006; 27: 483-94.
22. Powell H, Murphy VE, Taylor DR, et al. Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet 2011; 378: 983-90.
23. Moore WC, Meyers DA, Wenzel SE, et al. Identifi cation of asthma phenotypes using cluster analysis in the severe asthma research program. Am J Respir Crit Care Med 2010; 181: 315-23.
24. Bafadhel M, McKenna S, Terry S, et al. Acute exacerbations of chronic obstructive pulmonary disease: identifi cation of biologic clusters and their biomarkers. Am J Respir Crit Care Med 2011; 184: 662-71.
25. Heaney LG, Brightling CE, Menzies-Gow A, Stevenson M, Niven RM. Refractory asthma in the UK: cross-sectional fi ndings from a UK multicentre registry. Thorax 2010; 65: 787-94.
26. Pavord ID, Haldar P, Bradding P, Wardlaw AJ. Mepolizumab in refractory eosinophilic asthma. Thorax 2010; 65: 370.
27. Greulich T, Haldar P, Agbetile J, et al. FENO and blood eosinophil count as surrogate markers of eosinophilic airway infl ammation in patients with severe asthma. Eur Respir J 2012; 36: 1005s.
28. Adinoff AD, Hollister JR. Steroid-induced fractures and bone loss in patients with asthma. N Engl J Med 1983; 309: 265-68.