Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study
Health and Quality of Life Outcomes
Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study
Peter J Jongen 0
Dirk Lehnick 2
Evert Sanders 1
Pierette Seeldrayers 6
Sten Fredrikson 5
Magnus Andersson 4
Joachim Speck 3
FOCUS study group
0 MS4 Research Institute , Ubbergseweg 34, 6522 KJ Nijmegen , the Netherlands
1 Amphia Hospital , Breda , the Netherlands
2 STATPROC , Hohentengen am Hochrhein , Germany
3 Nuvisan GmbH , Neu-Ulm , Germany
4 Karolinska Universitetssjukhuset i Solna , Solna , Sweden
5 Division of Neurology Huddinge, Department of Clinical Neuroscience, Karolinska Institutet , Stockholm , Sweden
6 Hospital Civil de Charleroi , Charleroi , Belgium
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-nave patients had improved HRQoL (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-nave 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.
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Introduction
The efficacy of the disease modifying drug (DMD)
glatiramer acetate (GA) in reducing relapses in relapsing
remitting multiple sclerosis (RRMS) has been
demonstrated in randomized placebo-controlled trials [1,2].
Studies on the effectiveness of GA treatment in daily
neurological practice have concentrated on relapses,
disability, fatigue [3-5], work absenteeism [4] and
costeffectiveness [6,7].
Health-related quality of life (HR-QoL) is an overall
measure of effectiveness from a patients perspective and
is becoming increasingly important in the assessment of
therapies in chronic disorders. It has been demonstrated
that in MS patients treatment with the DMD
interferonbeta (INFb) is associated with an increase in HR-QoL
[8,9]. Data on HR-QoL during GA treatment are scarce
and not informative [8,10].
Fatigue and depression are primary determinants of
impaired HR-QoL in MS [11]. Fatigue is reported by
over 80% of patients [12] and often interferes with social
or occupational activities [13]. It has been suggested that
GA may improve MS-related fatigue [3,4]. Depressive
Table 1 Demographic and neurological characteristics of
patient groups
1.15 (0.62) 1.13 (0.50)
symptoms are also frequent in MS, the life-time
prevalence of major depressive disorders being 22% [14].
To investigate the overall benefit RRMS patients
perceive from GA treatment we performed a prospective,
observational, international, multi-centre study in
patients treated with GA in daily practice, focusing on
HR-QoL, fatigue, and depression (FOCUS study). Two
groups were studied, patients with prior
immunomodulation/immunosuppression (pre-treated group) and
patients without such treatment (treatment-nave group)
[15]. Here we report the results.
Methods
Study and study populations
Investigator-initiated, prospective, observational,
international, multi-centre study. Patients were recruited in
out-patient departments from general hospitals,
academic hospitals and MS centers in the Netherlands,
Sweden and Belgium. The protocol was submitted to
the Independent Review Board (IRB), an approved
ethical committee residing in Amsterdam, the Netherlands.
The IRB concluded that, because of the observational
design of the study, a review by an ethical committee
was not required. The study did not qualify for being
tested according to the Dutch Medical Research
Involving Human Subjects Act of 1999 [16]. Patients signed
an informed consent form before any study related
procedure was performed. The study was carried out in
compliance with the Helsin (...truncated)