Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis

Multiple Sclerosis and Related Disorders

Volumn 11, Issue , 2017, Pages 18-24

  Liu, Ying ^a   Vollmer, Timothy ^b   Havrdova, Eva ^c   Riester, Katherine ^a   Lee, Andrew ^a   Phillips, Glenn ^a   Wang, Ping ^a   Sabatella, Guido ^a  

^a BIOGEN   (United States)

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

^c CHARLES UNIVERSITY   (Czech Republic)

Author keywords

Daclizumab; Multiple sclerosis; Patient reported outcomes; Relapsing remitting

Indexed keywords

BETA1A INTERFERON; DACLIZUMAB; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PATIENT-REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TIME FACTOR; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; DOUBLE-BLIND METHOD; HUMANS; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTORS; INTERFERON BETA-1A; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PATIENT REPORTED OUTCOME MEASURES; TIME FACTORS; YOUNG ADULT;

EID: 84996605876     PISSN: 22110348     EISSN: 22110356     Source Type: Journal    
DOI: 10.1016/j.msard.2016.11.005     Document Type: Article

References (28)

1. Bamer, A.M., Johnson, K.L., Amtmann, D., Kraft, G.H., Prevalence of sleep problems in individuals with multiple sclerosis. Mult. Scler. 14 (2008), 1127–1130.
2. Cheung, K., Oemar, M., Oppe, M., Rabin, R., 2009. EQ-5D user guide: basic information on how to use EQ-5D. 〈http://www.euroqol.org/fileadmin/user_upload/Documenten/PDF/User_Guide_v2_March_2009.pdf〉 (accessed 28.10.15).
3. Confavreux, C., Vukusic, S., Accumulation of irreversible disability in multiple sclerosis: from epidemiology to treatment. Clin. Neurol. Neurosurg. 108 (2006), 327–332.
4. Deshpande, P.R., Rajan, S., Sudeepthi, B.L., Abdul Nazir, C.P., Patient-reported outcomes: a new era in clinical research. Perspect. Clin. Res. 2 (2011), 137–144.
5. Devlin, N.J., Krabbe, P.F., The development of new research methods for the valuation of EQ-5D–5L. Eur. J. Health Econ. 14:suppl 1 (2013), S1–S3.
6. European Medicines Agency, 2003. Points to consider on adjustment for baseline covariates. &$2lt;http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003639.pdf&$2gt; (accessed 15.8.16).
7. European Medicines Agency, 2014. Reflection paper on the use of patient reported outcome (PRO) measures in oncology studies. 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf 〉 (accessed 28.10.15).
8. European Medicines Agency, 2016. Daclizumab 150 mg for injection [summary of product characteristics]. 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003862/WC500210598.pdf〉 (accessed 29.08.16).
9. Göksel Karatepe, A., Kaya, T., Günaydn, R., Demirhan, A., Ce, P., Gedizlioğlu, M., Quality of life in patients with multiple sclerosis: the impact of depression, fatigue, and disability. Int. J. Rehabil. Res. 34 (2011), 290–298.
10. Gold, R., Giovannoni, G., et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet 381 (2013), 2167–2175.
11. Hemmett, L., Holmes, J., Barnes, M., Russell, N., What drives quality of life in multiple sclerosis?. QJM 97 (2004), 671–676.
12. Hobart, J., Lamping, D., Fitzpatrick, R., Riazi, A., Thompson, A., The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain 124 (2001), 962–973.
13. Hupperts, R., Lycke, J., et al.,2015. Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial [published online 28.4.15]. doi: 10.1177/1352458515581436.
14. Kappos, L., Wiendl, H., et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N. Engl. J. Med. 373 (2015), 1418–1428.
15. Lavery, A.M., Verhey, L.H., Waldman, A.T., Outcome measures in relapsing-remitting multiple sclerosis: capturing disability and disease progression in clinical trials. Mult. Scler. Int., 2014, 2014, 262350.
16. Lizán, L., Comellas, M., Paz, S., Poveda, J.L., Meletiche, D.M., Polanco, C., Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature. Patient Prefer. Adherence 8 (2014), 1653–1664.
17. Markowitz, C.E., The current landscape and unmet needs in multiple sclerosis. Am. J. Manag. Care 16:suppl 8 (2010), S211–S218.
18. Martin, R., Anti-CD25 (daclizumab) monoclonal antibody therapy in relapsing–remitting multiple sclerosis. Clin. Immunol. 142 (2012), 9–14.
19. Mitchell, A.J., Benito-León, J., González, J.M., Rivera-Navarro, J., Quality of life and its assessment in multiple sclerosis: integrating physical and psychological components of wellbeing. Lancet Neurol. 4 (2005), 556–566.
20. Newsome, S.D., Guo, S., et al. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult. Scler. Relat. Disord. 4 (2015), 350–357.
21. Phillips, G., Guo, S., et al. Assessing the impact of multiple sclerosis disease activity and daclizumab HYP treatment on patient-reported outcomes: results from the SELECT trial. Mult. Scler. Relat. Disord. 6 (2016), 66–72.
22. Phillips, G.A., Wyrwich, K.W., et al. Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening. Mult. Scler. 20 (2014), 1753–1760.
23. Polman, C.H., Reingold, S.C., et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann. Neurol. 58 (2005), 840–846.
24. Rabin, R., de Charro, F., EQ-5D: a measure of health status from the EuroQol Group. Ann. Med. 33 (2001), 337–343.
25. Strober, L.B., Fatigue in multiple sclerosis: a look at the role of poor sleep. Front Neurol., 6, 2015, 21.
26. US Food and Drug Administration, 2009. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 〈http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf〉 (accessed 28.10.15).
27. Vollmer, T., Havrdova, E. et al., 2013. Daclizumab high-yield process treatment reduced the impact of multiple sclerosis relapse on health-related quality of life (results of the SELECT trial). Presented at the 65th Annual Meeting of the American Academy of Neurology; March 16–23; San Diego, CA.
28. Wiendl, H., Gross, C.C., Modulation of IL-2Rα with daclizumab for treatment of multiple sclerosis. Nat. Rev. Neurol. 9 (2013), 394–404.