Health-Related Quality of Life in Multiple Sclerosis
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Health-related quality of life (HR-QOL) is an important measure of health in patients with multiple sclerosis (MS), given that MS symptoms affect many aspects of everyday living. Physicians may tend to focus on physical or cognitive changes in patients with MS because these measures involve physician-or psychologist-administered tests rather than patient self-reporting. However, a number of validated instruments are available to evaluate HR-QOL in clinical studies. Several studies have used these instruments to evaluate the effects of traditional disease-modifying therapies (DMTs), i.e. interferon-β and glatiramer acetate on HR-QOL in patients with MS. The results of many of these studies showed that DMTs improved some aspects of patients’ HR-QOL, but study design issues such as small patient numbers or lack of placebo control for comparison have made it difficult to interpret these results. Two large, randomized, placebo-controlled studies of the newest DMT, natalizumab, showed that this therapy resulted in significant improvements in HR-QOL in patients with relapsing MS. Furthermore, the effects of natalizumab on HR-QOL were apparent, regardless of disease characteristics. The natalizumab studies definitively show that HR-QOL measures can be informative in a clinical trial setting and support the position that patient-reported outcomes, including HR-QOL measures, should be included in clinical trials to more fully assess therapeutic efficacy.
KeywordsMultiple Sclerosis Expand Disability Status Scale Natalizumab Glatiramer Acetate Expand Disability Status Scale Score
The authors wish to acknowledge Hema Gowda, PharmD, Matthew Hasson, BA, and Jillian Licata, PhD, of Scientific Connexions for their editorial assistance in the preparation of this manuscript; their activities were supported by funding from Biogen Idec, Inc.
Biogen Idec has provided research funds to the Cleveland Clinic for Tysabri® (natalizumab) clinical trials. Dr Rudick has received consulting fees in the past year from Biogen Idec, Elan, Millennium Pharmaceuticals, Novartis and Wyeth, and has received research grants from Biogen Idec, Elan, the National Institutes of Health, and the National Multiple Sclerosis Society. Dr Miller has received speaker fees from Biogen Idec, and consulting fees from GlaxoSmithKline and Novartis.
- 6.Division of Mental Health, World Health Organization. The World Health Organization quality of life-100. Geneva: World Health Organization, 1995Google Scholar
- 7.Schipper H, Clinch JJ, Olweny CLM. Quality of life studies: definitions and conceptual issues. In: Spiler B, editor. Quality of life and pharmacoeconomics in clinical trials. Philadelphia (PA): Lippincott-Raven, 1996: 11–23Google Scholar
- 8.Canadian Burden of Illness Study Group. Burden of illness of multiple sclerosis: part II. Quality of life. Can J Neurol Sci 1998; 25: 31–8Google Scholar
- 13.PRISMS Study Group. Randomised, double-blind, placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet 1998; 352: 1498–504Google Scholar
- 22.Ritvo PG, Fischer JF, Miller DM, et al. Multiple sclerosis quality of life inventory: a user’s manual. New York (NY): National Multiple Sclerosis Society, 1997Google Scholar
- 23.National Multiple Sclerosis Society, Consortium of Multiple Sclerosis Centers. Multiple sclerosis quality of life inventory: a user’s manual. New York: National Multiple Sclerosis Society, 1997Google Scholar