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Open Access Research

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 Jongen1*, Dirk Lehnick2, Evert Sanders3, Pierette Seeldrayers4, Sten Fredrikson5, Magnus Andersson6, Joachim Speck7 and FOCUS study group

Author Affiliations

1 MS4 Research Institute, Ubbergseweg 34, 6522 KJ Nijmegen, the Netherlands

2 STATPROC, Hohentengen am Hochrhein, Germany

3 Amphia Hospital, Breda, the Netherlands

4 Hospital Civil de Charleroi, Charleroi, Belgium

5 Division of Neurology Huddinge, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

6 Karolinska Universitetssjukhuset i Solna, Solna, Sweden

7 Nuvisan GmbH, Neu-Ulm, Germany

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Health and Quality of Life Outcomes 2010, 8:133  doi:10.1186/1477-7525-8-133

Published: 15 November 2010

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.