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Immunomodulatory treatment of multiple sclerosis in Denmark: a prospective nationwide survey

Danish Multiple Sclerosis Research Centre, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, pss{at}rh.dk

Nils Koch-Henriksen

Department of Neurology, Aalborg Hospital, Aalborg, Denmark and The Danish MS Treatment Register, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

Mads Ravnborg

Danish Multiple Sclerosis Research Centre, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Jette Lautrup Frederiksen

Department of Neurology, Copenhagen University Hospital Glostrup, Glostrup, Denmark

K ai Jensen

Department of Neurology, Hillerod Hospital, Hillerod, Denmark

Anne Heltberg

Department of Neurology, Roskilde Hospital, Roskilde, Denmark

Hanne Schaldemose

Department of Neurology, Holbaek Hospital, Holbaek, Denmark

Sven Deth

Department of Neurology, Naestved Hospital, Naestved, Denmark

O le Kristensen

Department of Neurology, Odense University Hospital, Odense, Denmark

Mogens Worm

Department of Neurology, Sonderborg Hospital, Sonderborg, Denmark

Egon Stenager

Department of Neurology, Esbjerg Hospital, Esbjerg, Denmark and Department of Neurology, Vejle Hospital, Vejle Hospital, Denmark

Hans Jacob Hansen

Department of Neurology, Aarhus University Hospital, Aarhus, Denmark

Bjarne Sivertsen

Department of Neurology, Viborg Hospital, Viborg, Denmark

Jesper Torring

Department of Neurology, Holstebro Hospital, Holstebro, Denmark

Danish Multiple Sclerosis Study Group

Objective: The aim of the present study was to provide data on the use of immunomodulatory therapies in a population comprising all treated patients with relapsing-remitting multiple sclerosis (RRMS) in Denmark. Patients and methods: From the introduction of immunomodulatory therapy in Denmark in 1996 through 2003, all patients that started immunomodulatory therapy were followed prospectively with neurological examination and standard laboratory tests every six months, and clinical data were reported to the MS Treatment Register, including relapses, Expanded Disability Status Scale scores and side effects. Results: From 1996 through 2003 in all 2393 patients had started immunomodulatory therapy for RRMS, of whom 1252 (52.3%) were still on therapy with the same product at follow-up on 1 January 2005, whereas 1141 patients had discontinued or changed immunomodulatory therapy. Multiple Cox regression analysis of the risk of suffering a relapse showed a hazard ratio of 1.48 in patients with three or more relapses in the 24 months prior to onset compared with patients with two relapses or less; the hazard ratio was 0.84 in patients with age 38 years at treatment start compared with patients of age <38, and 1.17 for females compared with males. For disease progression the hazard ratio was 1.24 for age = 38 years compared with age 37 years. Significant differences were observed in the hazard ratios between the different preparations, probably due to selection bias. Conclusion: The response to immunomodulatory therapy can be predicted to some extent from demographic variables. Differences between preparations can mainly be ascribed to selection bias, and open studies are not suited for comparison of efficacy between different preparations.

Key Words: adverse effects • epidemiology • immunotherapy • interferon-beta • multiple sclerosis • treatment outcome

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