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

The Lancet Respiratory Medicine

Volumn 5, Issue 5, 2017, Pages 390-400

  Chupp, Geoffrey L ^a   Bradford, Eric S ^b   Albers, Frank C ^b   Bratton, Daniel J ^c   Wang Jairaj, Jie ^c   Nelsen, Linda M ^b   Trevor, Jennifer L ^d   Magnan, Antoine ^e   ten Brinke, Anneke ^f  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b GLAXOSMITHKLINE   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d University of Alabama at Birmingham   (United States)

^e UNIVERSITÉ DE NANTES   (France)

^f MEDICAL CENTER LEEUWARDEN   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; MEPOLIZUMAB; OMALIZUMAB; PLACEBO; BRONCHODILATING AGENT; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; ARTICLE; ASTHMA; CHILD; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; EOSINOPHIL COUNT; EOSINOPHILIC ASTHMA; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; GENERAL HEALTH STATUS ASSESSMENT; HEADACHE; HEALTH CARE QUALITY; HEMATOLOGIC DISEASE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PEAK EXPIRATORY FLOW; PHASE 3 CLINICAL TRIAL; PHYSICAL ACTIVITY; PRIORITY JOURNAL; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; ST. GEORGE RESPIRATORY QUESTIONNAIRE; YOUNG ADULT; AGED; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; EOSINOPHILIA; MIDDLE AGED; QUALITY OF LIFE; RECURRENT DISEASE; SEVERITY OF ILLNESS INDEX; SYMPTOM ASSESSMENT;

ADRENAL CORTEX HORMONES; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; BRONCHODILATOR AGENTS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EOSINOPHILIA; FEMALE; HEADACHE; HUMANS; MALE; MIDDLE AGED; NASOPHARYNGITIS; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SYMPTOM ASSESSMENT; SYMPTOM FLARE UP;

EID: 85017095118     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(17)30125-X     Document Type: Article

References (30)

1. 1 Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. http://ginasthma.org/wp-content/uploads/2016/04/GINA-2016-main-report_tracked.pdf, 2016 (accessed Feb 18, 2017).
2. 2 Arpinelli, F, Carone, M, Riccardo, G, Bertolotti, G, Health-related quality of life measurement in asthma and chronic obstructive pulmonary disease: review of the 2009–2014 literature. Multidiscip Respir Med, 11, 2015, 5.
3. 3 Wenzel, SE, Asthma: defining of the persistent adult phenotypes. Lancet 368 (2006), 804–813.
4. 4 Chung, KF, Wenzel, SE, Brozek, JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 43 (2014), 343–373.
5. 5 Calhoun, WJ, Haselkorn, T, Miller, DP, Omachi, TA, Asthma exacerbations and lung function in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol 136 (2015), 1125–1127 e4.
6. 6 Jones, PW, Quirk, FH, Baveystock, CM, Littlejohns, P, A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis 145 (1992), 1321–1327.
7. 7 Sanjuas, C, Alonso, J, Prieto, L, Ferrer, M, Broquetas, JM, Anto, JM, Health-related quality of life in asthma: a comparison between the St George's Respiratory Questionnaire and the Asthma Quality of Life Questionnaire. Qual Life Res 11 (2002), 729–738.
8. 8 Reddel, HK, Taylor, DR, Bateman, ED, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med 180 (2009), 59–99.
9. 9 Wright, A, Hannon, J, Hegedus, EJ, Kavchak, AE, Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther 20 (2012), 160–166.
10. 10 Jones, PW, Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 19 (2002), 398–404.
11. 11 Wyrwich, KW, Norquist, JM, Lenderking, WR, Acaster, S, Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res 22 (2013), 475–483.
12. 12 Nelsen, L, Kimel, K, Murray, L, et al. Qualitative evaluation of the St George's Respiratory Questionnaire in patients with severe asthma Respir Med. http://www.sciencedirect.com/science/article/pii/S0954611117300434, 2017.
13. 13 GlaxoSmithKline. Mepolizumab (NUCALA) US prescribing information. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL.PDF (accessed Feb 18, 2017).
14. 14 UK GlaxoSmithKline. Mepolizumab (NUCALA) EU summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf (accessed Feb 18, 2017).
15. 15 Pavord, ID, Korn, S, Howarth, P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 380 (2012), 651–659.
16. 16 Ortega, HG, Liu, MC, Pavord, ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 371 (2014), 1198–1207.
17. 17 Bel, EH, Wenzel, SE, Thompson, PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 371 (2014), 1189–1197.
18. 18 GlaxoSmithKline. A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe eosinophilic asthma on markers of asthma control. https://www.gsk-clinicalstudyregister.com/study/200862#ps (accessed Feb 18, 2017).
19. 19 Cope, S, Donohue, JF, Jansen, JP, et al. Comparative efficacy of long-acting bronchodilators for COPD: a network meta-analysis. Respir Res, 14, 2013, 100.
20. 20 Siler, TM, Donald, AC, O'Dell, D, Church, A, Fahy, WA, A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis 11 (2016), 971–979.
21. 21 Singh, D, Ferguson, GT, Bolitschek, J, et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Respir Med 109 (2015), 1312–1319.
22. 22 Cloutier, MM, Schatz, M, Castro, M, et al. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol Pract 129:3 suppl (2012), S24–S33.
23. 23 Haldar, P, Pavord, ID, Shaw, DE, et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 178 (2008), 218–224.
24. 24 Barnes, PJ, Therapeutic approaches to asthma-chronic obstructive pulmonary disease overlap syndromes. J Allergy Clin Immunol Pract 136 (2015), 531–545.
25. 25 Barbaro, MP, Lacedonia, D, Palladino, GP, et al. Dyspnea perception in asthma: role of airways inflammation, age and emotional status. Respir Med 105 (2011), 195–203.
26. 26 Veen, JC, Smits, HH, Ravensberg, AJ, Hiemstra, PS, Sterk, PJ, Bel, EH, Impaired perception of dyspnea in patients with severe asthma. Relation to sputum eosinophils. Am J Respir Crit Care Med 158 (1998), 1134–1141.
27. 27 Castro, M, Wenzel, SE, Bleecker, ER, et al. Benralizumab, an anti-interleukin 5 receptor alpha monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med 2 (2014), 879–890.
28. 28 Castro, M, Zangrilli, J, Wechsler, ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med 3 (2015), 355–366.
29. 29 Homer, RJ, Elias, JA, Airway remodeling in asthma: therapeutic implications of mechanisms. Physiology (Bethesda) 20 (2005), 28–35.
30. 30 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 4 (2016), 549–556.