Assessing the impact of multiple sclerosis disease activity and daclizumab HYP treatment on patient-reported outcomes: Results from the SELECT trial

Multiple Sclerosis and Related Disorders

Volumn 6, Issue , 2016, Pages 66-72

  Phillips, Glenn ^a   Guo, Shien ^b   Bender, Randall ^b   Havrdová, Eva ^c   Proskorovsky, Irina ^d   Vollmer, Timothy ^e  

^a BIOGEN   (United States)

^b EVIDERA   (United States)

^c CHARLES UNIVERSITY   (Czech Republic)

^d Modeling and Simulation   (Canada)

^e UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

Author keywords

Daclizumab high yield process; MS specific health related quality of life measures; Multiple Sclerosis Impact Scale; Relapsing and remitting multiple sclerosis

Indexed keywords

ALPHA INTERFERON; ANTINEOPLASTIC AGENT; AZATHIOPRINE; BETA1A INTERFERON; CYCLOPHOSPHAMIDE; DACLIZUMAB; FINGOLIMOD; FUMARIC ACID; FUMARIC ACID DIMETHYL ESTER; GLATIRAMER; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; INTERFERON BETA SERINE; LAQUINIMOD; METHOTREXATE; MITOXANTRONE; NATALIZUMAB; PLACEBO; TERIFLUNOMIDE; THYMOSTIMULIN; DACLIZUMAB HYP; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

ADULT; ARTICLE; CONTROLLED STUDY; DISABILITY; DISEASE ACTIVITY; EXPLORATORY RESEARCH; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS IMPACT SCALE; PLASMAPHERESIS; POST HOC ANALYSIS; QUALITY OF LIFE; RATING SCALE; RELAPSE; SHORT FORM 12; TREATMENT OUTCOME; ANALYSIS OF VARIANCE; DISEASE COURSE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; TIME FACTOR;

ADULT; ANALYSIS OF VARIANCE; ANTIBODIES, MONOCLONAL, HUMANIZED; DISABILITY EVALUATION; DISEASE PROGRESSION; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; MALE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; QUALITY OF LIFE; SELF REPORT; TIME FACTORS; TREATMENT OUTCOME;

EID: 84962536674     PISSN: 22110348     EISSN: 22110356     Source Type: Journal    
DOI: 10.1016/j.msard.2016.02.001     Document Type: Article

References (32)

1. D.S. Bandari, T.L. Vollmer, B.O. Khatri, and et al. Assessing quality of life in patients with multiple sclerosis Int. J. MS Care 12 1 2010 34 41
2. W. Castro-Borrero, D. Graves, T.C. Frohman, and et al. Current and emerging therapies in multiple sclerosis: A systematic review Ther. Adv. Neurol. Disord. 5 4 2012 205 220
3. Cheung, K.O., Oppe, M. Rabin, M.R., 2013. EQ-5D User Guide: Basic Information on How to Use EQ-5D. 2009, (http://www.euroqol.org/fileadmin/user-upload/Documenten/PDF/User-Guide-v2-March-2009.pdf) (accessed 14.02.13).
4. G. EuroQol EuroQol - a new facility for the measurement of health-related quality of life Health Policy 16 3 1990 199 208
5. G. Giovannoni, R. Gold, K. Selmaj, and et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): A multicentre, randomised, double-blind extension trial Lancet Neurol. 13 5 2014 472 481
6. Gold R., Giovannoni G., Selmaj K., et al., 2012. A randomised, double-blind, placebo-controlled trial of daclizumab HYP in relapsing-remitting multiple sclerosis. Submitted.
7. R. Gold, G. Giovannoni, K. Selmaj, and et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): A randomised, double-blind, placebo-controlled trial Lancet 381 9884 2013 2167 2175
8. E. Havrdova, G. Giovannoni, D. Stefoski, and et al. Disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study Mult. Scler. 20 4 2014 464 470
9. B.C. Healy, I.R. Degano, A. Schreck, and et al. The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis Qual. Life Res. 21 10 2012 1677 1684
10. L. Hemmett, J. Holmes, M. Barnes, and et al. What drives quality of life in multiple sclerosis? QJM 97 10 2004 671 676
11. J. Hobart, D. Lamping, R. Fitzpatrick, and et al. The Multiple Sclerosis Impact Scale (MSIS-29): A new patient-based outcome measure Brain 124 Pt 5 2001 962 973
12. N.P. Hurst, P. Jobanputra, M. Hunter, and et al. Validity of Euroqol - a generic health status instrument - in patients with rheumatoid arthritis. Economic and Health Outcomes Research Group Br. J. Rheumatol. 33 7 1994 655 662
13. V. Janardhan, and R. Bakshi Quality of life and its relationship to brain lesions and atrophy on magnetic resonance images in 60 patients with multiple sclerosis Arch. Neurol. 57 10 2000 1485 1491
14. K.H. Jones, D.V. Ford, P.A. Jones, and et al. The physical and psychological impact of Multiple Sclerosis using the MSIS-29 via the web portal of the UK MS Register PLoS One 8 1 2013 e55422
15. Kappos, L., Selmaj, K., Arnold, D.L., et al., 2015. Daclizumab high-yield processreduced disabling relapses and the rate of severe/serious relapses: post hoc analyses of the SELECT and DECIDE Studies. The 1st Congress of the European Academy of Neurology, June 20-23, 2015, Berlin, Germany.
16. L. Kappos, K. Selmaj, D.L. Arnold, and et al. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis N. Engl. J. Med. 373 15 2015 1418 1428
17. S. Kern, W. Schrempf, H. Schneider, and et al. Neurological disability, psychological distress, and health-related quality of life in MS patients within the first three years after diagnosis Mult. Scler. 15 6 2009 752 758
18. T. Knezevic, L. Konstantinovic, S. Rodic, and et al. Validity and reliability of the Serbian version of Patient-Reported Impact of Spasticity Measure in multiple sclerosis Int. J. Rehabil. Res. 3 38 2015 199 205
19. I.S. Lobentanz, S. Asenbaum, K. Vass, and et al. Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality Acta Neurol. Scand. 110 1 2004 6 13
20. C. McGuigan, and M. Hutchinson The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure J. Neurol. Neurosurg. Psychiatry 75 2 2004 266 269
21. H. Naci, R. Fleurence, J. Birt, and et al. The impact of increasing neurological disability of multiple sclerosis on health utilities: A systematic review of the literature J. Med. Econ. 13 1 2010 78 89
22. M.W. Nortvedt, T. Riise, K.M. Myhr, and et al. Quality of life in multiple sclerosis: measuring the disease effects more broadly Neurology 53 5 1999 1098 1103
23. M.W. Nortvedt, T. Riise, K.M. Myhr, and et al. Performance of the SF-36, SF-12, and RAND-36 summary scales in a multiple sclerosis population Med. Care 38 10 2000 1022 1028
24. J.H. Noseworthy, C. Lucchinetti, M. Rodriguez, and et al. Multiple sclerosis N. Engl. J. Med. 343 13 2000 938 952
25. M. Orme, J. Kerrigan, D. Tyas, and et al. The effect of disease, functional status, and relapses on the utility of people with multiple sclerosis in the UK Value Health 10 1 2007 54 60
26. S. Özakbas, B. Akdede, G. Kösehasanogullari, and et al. Difference between generic and multiple sclerosis-specific quality of life instruments regarding the assessment of treatment efficacy J. Neurol. Sci. 256 1 2007 30 34
27. G.A. Phillips, K.W. Wyrwich, S. Guo, and et al. Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening Mult. Scler. 20 13 2014 1753 1760
28. C.H. Polman, S.C. Reingold, G. Edan, and et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria" Ann. Neurol. 58 6 2005 840 846
29. N. Putzki, J. Fischer, K. Gottwald, and et al. Quality of life in 1000 patients with early relapsing-remitting multiple sclerosis Eur. J. Neurol. 16 6 2009 713 720
30. R.A. Rudick, D. Miller, S. Hass, and et al. Health-related quality of life in multiple sclerosis: effects of natalizumab Ann. Neurol. 62 4 2007 335 346
31. J. Ware Jr., M. Kosinski, and S.D. Keller A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity Med. Care 34 3 1996 220 233
32. N. Wu, S.L. Minden, D.C. Hoaglin, and et al. Quality of life in people with multiple sclerosis: data from the Sonya Slifka Longitudinal Multiple Sclerosis Study J. Health Hum. Serv. Adm. 30 3 2007 233 267