Skip to main content
Top
Published in: Health and Quality of Life Outcomes 1/2010

Open Access 01-12-2010 | Research

Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study

Authors: Peter J Jongen, Dirk Lehnick, Evert Sanders, Pierette Seeldrayers, Sten Fredrikson, Magnus Andersson, Joachim Speck, FOCUS study group

Published in: Health and Quality of Life Outcomes | Issue 1/2010

Login to get access

Abstract

Background

Glatiramer acetate (GA) and interferon-beta (INFb) are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS). Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL) in the first 12 months. It is not known whether HR-QoL increases during treatment with GA.

Methods

197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32), fatigue (Fatigue Impact Scale [FIS]) and depressed mood (Beck Depression Inventory-Short Form [BDI-SF]) at baseline and 6 and 12 months after start of GA treatment.

Results

At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p < 0.001), not in the pre-treated group. At month 12 43% of treatment-naïve patients had improved HR-QoL (increase LMS-QoL score 3 or more points) (p < 0.001). Likewise, mean FIS scores were decreased at months 6 and 12 in the treatment-naïve group (p < 0.01), not in the pre-treated group. In both groups mean BDI-SF scores did not change. No demographic or clinical baseline factor was predictive of HR-QoL increase. HR-QoL changes were zero to negative for patients who had discontinued GA before month 12 (28.4% of patients).

Conclusions

In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.
Literature
1.
go back to reference Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB: Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995, 45: 1268–1276.PubMedCrossRef Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB: Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995, 45: 1268–1276.PubMedCrossRef
2.
go back to reference Comi G, Filippi M, Wolinskt JS: European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001, 49: 290–297. 10.1002/ana.64PubMedCrossRef Comi G, Filippi M, Wolinskt JS: European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001, 49: 290–297. 10.1002/ana.64PubMedCrossRef
3.
go back to reference Metz LM, Patten SB, Archibald CJ, Bakker JI, Harris CJ, Patry DG, Bell RB, Yeung M, Murphy WF, Stoian CA, Billesberger K, Tillotson L, Peters S, McGowan D: The effect of immunomodulatory treatment on multiple sclerosis fatigue. J Neurol Neurosurg Psych 2004, 75: 1045–1047. 10.1136/jnnp.2002.007724CrossRef Metz LM, Patten SB, Archibald CJ, Bakker JI, Harris CJ, Patry DG, Bell RB, Yeung M, Murphy WF, Stoian CA, Billesberger K, Tillotson L, Peters S, McGowan D: The effect of immunomodulatory treatment on multiple sclerosis fatigue. J Neurol Neurosurg Psych 2004, 75: 1045–1047. 10.1136/jnnp.2002.007724CrossRef
4.
go back to reference Ziemssen T, Hoffman J, Apfel R, Kern S: Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis. Health Qual Life Outcomes 2008, 6: 67. 10.1186/1477-7525-6-67PubMedCentralPubMedCrossRef Ziemssen T, Hoffman J, Apfel R, Kern S: Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis. Health Qual Life Outcomes 2008, 6: 67. 10.1186/1477-7525-6-67PubMedCentralPubMedCrossRef
5.
go back to reference Hadjimicheal O, Vollmer T, Oleen-Burkey M, North American Research Committee on Multiple Sclerosis: Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey. Health Qual Life Outcomes 2008, 14: 100. 10.1186/1477-7525-6-100CrossRef Hadjimicheal O, Vollmer T, Oleen-Burkey M, North American Research Committee on Multiple Sclerosis: Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey. Health Qual Life Outcomes 2008, 14: 100. 10.1186/1477-7525-6-100CrossRef
6.
go back to reference Bell C, Graham J, Earnshaw S, Oleen-Burkey M, Castelli-Haley J, Johnson K: Cost-effectiveness of four immunomodulatory therapies for relapsing-remitting multiple sclerosis: a Markov model based on long-term clinical data. J Manag Care Pharm 2007, 13: 245–261.PubMed Bell C, Graham J, Earnshaw S, Oleen-Burkey M, Castelli-Haley J, Johnson K: Cost-effectiveness of four immunomodulatory therapies for relapsing-remitting multiple sclerosis: a Markov model based on long-term clinical data. J Manag Care Pharm 2007, 13: 245–261.PubMed
7.
go back to reference Tappenden P, McCabe C, Chilcott J, Simpson E, Nixon R, Madan J, Fisk JD, Brown M: Cost-Effectiveness of Disease-Modifying Therapies in the Management of Multiple Sclerosis for the Medicare Population. Value Health 2009, in press. Tappenden P, McCabe C, Chilcott J, Simpson E, Nixon R, Madan J, Fisk JD, Brown M: Cost-Effectiveness of Disease-Modifying Therapies in the Management of Multiple Sclerosis for the Medicare Population. Value Health 2009, in press.
8.
go back to reference Lily O, McFadden E, Hensor E, Johnson M, Ford H: Disease-specific quality of life in multiple sclerosis: the effect of disease modifying treatement. Mult Scler 2006, 12: 808–813. 10.1177/1352458506070946PubMedCrossRef Lily O, McFadden E, Hensor E, Johnson M, Ford H: Disease-specific quality of life in multiple sclerosis: the effect of disease modifying treatement. Mult Scler 2006, 12: 808–813. 10.1177/1352458506070946PubMedCrossRef
9.
go back to reference Jongen PJ, Sindic C, Carton H, Zwanikken C, Lemmens W, Borm G: Functional composite and quality of Life in Avonex-treated Relapsing multiple sclerosis patients (FLAIR) study group: Improvement of health-related quality of life in relapsing remitting multiple sclerosis patients after 2 years of treatment with intramuscular interferon-beta-1a. J Neurol 2010, 257: 584–589. 10.1007/s00415-009-5378-xPubMedCrossRef Jongen PJ, Sindic C, Carton H, Zwanikken C, Lemmens W, Borm G: Functional composite and quality of Life in Avonex-treated Relapsing multiple sclerosis patients (FLAIR) study group: Improvement of health-related quality of life in relapsing remitting multiple sclerosis patients after 2 years of treatment with intramuscular interferon-beta-1a. J Neurol 2010, 257: 584–589. 10.1007/s00415-009-5378-xPubMedCrossRef
10.
go back to reference Guarnaccia JB, Aslan M, O'Connor TZ, Hope M, Kazis L, Kashner CM, Booss J: Quality of life for veterans with multiple sclerosis on disease-modifying agents: Relationship to disability. J Rehabil Res Dev 2006, 43: 25–44. 10.1682/JRRD.2006.11.0139CrossRef Guarnaccia JB, Aslan M, O'Connor TZ, Hope M, Kazis L, Kashner CM, Booss J: Quality of life for veterans with multiple sclerosis on disease-modifying agents: Relationship to disability. J Rehabil Res Dev 2006, 43: 25–44. 10.1682/JRRD.2006.11.0139CrossRef
11.
go back to reference Ziemssen T: Multiple sclerosis beyond EDSS: depression and fatigue. J Neurol Sci 2009,277(Suppl 1):S37–41. 10.1016/S0022-510X(09)70011-5PubMedCrossRef Ziemssen T: Multiple sclerosis beyond EDSS: depression and fatigue. J Neurol Sci 2009,277(Suppl 1):S37–41. 10.1016/S0022-510X(09)70011-5PubMedCrossRef
12.
go back to reference Krupp LB: Mechanisms, measurement, and management of fatigue in multiple sclerosis. In Multiple sclerosis: clinical challenges and controversies. Edited by: Thompson AJ, Polman C, Hohlfeld R. London, Martin Dunitz; 1997:283–294. Krupp LB: Mechanisms, measurement, and management of fatigue in multiple sclerosis. In Multiple sclerosis: clinical challenges and controversies. Edited by: Thompson AJ, Polman C, Hohlfeld R. London, Martin Dunitz; 1997:283–294.
13.
go back to reference Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ: The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994, 21: 9–14.PubMed Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ: The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994, 21: 9–14.PubMed
14.
go back to reference Patten SB, Metz LM, Reimer MA: Biopsychosocial correlates of lifetime major depression in a multiple sclerosis population. Mult Scler 2000, 6: 115–120.PubMedCrossRef Patten SB, Metz LM, Reimer MA: Biopsychosocial correlates of lifetime major depression in a multiple sclerosis population. Mult Scler 2000, 6: 115–120.PubMedCrossRef
15.
go back to reference Zwibel HL, Copolymer-1 Treatment Study Principal Investigators: Glatiramer acetate in treatment-naïve and prior interferon-beta-1b-treated multiple sclerosis patients. Acta Neurol Scand 2006, 113: 378–86. 10.1111/j.1600-0404.2006.00627.xPubMedCrossRef Zwibel HL, Copolymer-1 Treatment Study Principal Investigators: Glatiramer acetate in treatment-naïve and prior interferon-beta-1b-treated multiple sclerosis patients. Acta Neurol Scand 2006, 113: 378–86. 10.1111/j.1600-0404.2006.00627.xPubMedCrossRef
16.
go back to reference Ministerie van Volksgezondheid , Welzijn en Sport : Dutch Medical Research Involving Human Subjects Act (WMO). International Publication Series Health, Welfare and Sport nr.2. The Hague 2000. Ministerie van Volksgezondheid , Welzijn en Sport : Dutch Medical Research Involving Human Subjects Act (WMO). International Publication Series Health, Welfare and Sport nr.2. The Hague 2000.
17.
go back to reference Ford HL, Gerry E, Tennant A, Whally D, Haigh R, Johnson MH: Developing a disease-specific quality of life measure for people with multiple sclerosis. Clin Rehabil 2001, 15: 247–25. 10.1191/026921501673658108PubMedCrossRef Ford HL, Gerry E, Tennant A, Whally D, Haigh R, Johnson MH: Developing a disease-specific quality of life measure for people with multiple sclerosis. Clin Rehabil 2001, 15: 247–25. 10.1191/026921501673658108PubMedCrossRef
18.
go back to reference Ford HL, Gerry E, Johnson MH, Tennant A: Health status and quality of life of people with multiple sclerosis. Disabil Rehabil 2001, 23: 516–521. 10.1080/09638280010022090PubMedCrossRef Ford HL, Gerry E, Johnson MH, Tennant A: Health status and quality of life of people with multiple sclerosis. Disabil Rehabil 2001, 23: 516–521. 10.1080/09638280010022090PubMedCrossRef
19.
go back to reference Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW: A health-related quality of life measure for multiple sclerosis. Qual Lif Res 1995, 4: 187–206. 10.1007/BF02260859CrossRef Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW: A health-related quality of life measure for multiple sclerosis. Qual Lif Res 1995, 4: 187–206. 10.1007/BF02260859CrossRef
20.
go back to reference Ford HL, Eyres S, Tennant A: Measuring change in multiple sclerosis: responsiveness of three outcome measures. J Neurol Sci 2001, 187: S456. Ford HL, Eyres S, Tennant A: Measuring change in multiple sclerosis: responsiveness of three outcome measures. J Neurol Sci 2001, 187: S456.
21.
go back to reference Greenhaigh J, Ford AF, Long AF, Hurst K: The MS symptom and impact diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis. J Neurol Neurosurg Psychiatry 2004, 75: 577–82. 10.1136/jnnp.2003.020529CrossRef Greenhaigh J, Ford AF, Long AF, Hurst K: The MS symptom and impact diary (MSSID): psychometric evaluation of a new instrument to measure the day to day impact of multiple sclerosis. J Neurol Neurosurg Psychiatry 2004, 75: 577–82. 10.1136/jnnp.2003.020529CrossRef
22.
go back to reference Fisk JD, Ritvo PG, Rossi L, Haase DA, Marrie TJ, Schlech WF: Measuring the functional impact of fatigue: initial validation of impact scale. Clin Infect Dis 1994,18(Suppl 1):S79–83.PubMedCrossRef Fisk JD, Ritvo PG, Rossi L, Haase DA, Marrie TJ, Schlech WF: Measuring the functional impact of fatigue: initial validation of impact scale. Clin Infect Dis 1994,18(Suppl 1):S79–83.PubMedCrossRef
23.
go back to reference Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C: Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci 2004, 218: 103–108. 10.1016/j.jns.2003.11.005PubMedCrossRef Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C: Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci 2004, 218: 103–108. 10.1016/j.jns.2003.11.005PubMedCrossRef
24.
go back to reference Beck AT, Rial WY, Rickels K: Short form of depression inventory: cross-validation. Psychol Rep 1974, 34: 1184–1186.PubMed Beck AT, Rial WY, Rickels K: Short form of depression inventory: cross-validation. Psychol Rep 1974, 34: 1184–1186.PubMed
25.
go back to reference Moran PJ, Mohr DC: The validity of Beck Depression Inventory and Hamilton Rating Scale for Depression items in the assessment of depression among patients with multiple sclerosis. J Behav Med 2005, 28: 35–41. 10.1007/s10865-005-2561-0PubMedCrossRef Moran PJ, Mohr DC: The validity of Beck Depression Inventory and Hamilton Rating Scale for Depression items in the assessment of depression among patients with multiple sclerosis. J Behav Med 2005, 28: 35–41. 10.1007/s10865-005-2561-0PubMedCrossRef
26.
go back to reference Sharrack B, Hughes RAC: The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler 1999, 5: 223–233.PubMedCrossRef Sharrack B, Hughes RAC: The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler 1999, 5: 223–233.PubMedCrossRef
27.
go back to reference Hoogervorst ELJ, Van Winsen LML, Eikelboom MJ, Kalkers NF, Uitdehaag BMJ, Polman CH: Comparisons of patient self-report, neurologic examination, and functional impairment in MS. Neurology 2001, 56: 934–937.PubMedCrossRef Hoogervorst ELJ, Van Winsen LML, Eikelboom MJ, Kalkers NF, Uitdehaag BMJ, Polman CH: Comparisons of patient self-report, neurologic examination, and functional impairment in MS. Neurology 2001, 56: 934–937.PubMedCrossRef
28.
go back to reference Mitchell AJ, Benito-Sanchez J, Gonzalez JM, Rivera-Navarro J: Quality of life and its assessment in multiple sclerosis: integrating physical and psychological components of wellbeing. Lancet Neurol 2005, 4: 556–566. 10.1016/S1474-4422(05)70166-6PubMedCrossRef Mitchell AJ, Benito-Sanchez J, Gonzalez JM, Rivera-Navarro J: Quality of life and its assessment in multiple sclerosis: integrating physical and psychological components of wellbeing. Lancet Neurol 2005, 4: 556–566. 10.1016/S1474-4422(05)70166-6PubMedCrossRef
29.
go back to reference Arnoldus JH, Killestein J, Pfennings LE, Jelles B, Uitdehaag BM, Polman CH: Quality of life during the first 6 months of interferon-beta treatment in patients with MS. Mult Scler 2000, 6: 338–342.PubMed Arnoldus JH, Killestein J, Pfennings LE, Jelles B, Uitdehaag BM, Polman CH: Quality of life during the first 6 months of interferon-beta treatment in patients with MS. Mult Scler 2000, 6: 338–342.PubMed
Metadata
Title
Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study
Authors
Peter J Jongen
Dirk Lehnick
Evert Sanders
Pierette Seeldrayers
Sten Fredrikson
Magnus Andersson
Joachim Speck
FOCUS study group
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2010
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-8-133

Other articles of this Issue 1/2010

Health and Quality of Life Outcomes 1/2010 Go to the issue