Subgroups of the BENEFIT study : risk of developing MS and treatment effect of interferon beta-1b

Polman, C. and Kappos, L. and Freedman, M. S. and Edan, G. and Hartung, H. P. and Miller, D. H. and Montalbán, X. and Barkhof, F. and Selmaj, K. and Uitdehaag, B. M. and Dahms, S. and Bauer, L. and Pohl, C. and Sandbrink, R. and Benefit, investigators. (2008) Subgroups of the BENEFIT study : risk of developing MS and treatment effect of interferon beta-1b. Journal of neurology, Vol. 255, H. 4. pp. 480-487.

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Official URL: http://edoc.unibas.ch/dok/A6004555

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BACKGROUND : The BENEFIT study examined interferon beta (IFNB)-1b treatment in patients with clinically isolated syndrome (CIS) and < or = 2 clinically silent brain MRI lesions. METHODS : Subgroups of 468 patients (IFNB-1b: n = 292; placebo: n = 176) were created for demographics, clinical, laboratory, and MRI findings at onset. The 'natural' risk of clinically definite MS (CDMS) over 2 years was estimated by Kaplan Meier statistics in placebo-treated patients; the IFNB-1b treatment effect was analysed by Cox proportional hazards regression. RESULTS : The risk of CDMS was increased in placebo-treated patients (overall 45 %) if they were younger ( or = 9 T2-lesions (48%) or < or = 1 gadolinium (Gd)-enhancing lesions (52 %). The CDMS risk was highest (75 %) in placebo-treated patients with monofocal disease onset displaying MRI disease activity (< or = 1 Gd-lesion) and dissemination (< or = 9 T2-lesions). Treatment effects were significant across almost all subgroups including patients with less disease dissemination/activity at onset (monofocal: 55%; or = 9 T2-lesions (61 %), Gd-lesions (58 %), or both (65 %). CONCLUSIONS : This study confirms the impact of age of onset, CSF and MRI findings on risk of conversion from CIS to CDMS. IFNB-1b treatment effect was robust across the study population including patients without MRI disease activity and less clinical or MRI disease dissemination at onset and patients not receiving steroids for the CIS.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
UniBasel Contributors:Kappos, Ludwig
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:25 Apr 2014 08:01
Deposited On:25 Apr 2014 08:01

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