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

Autor: Chris, Polman, Ludwig, Kappos, Mark S, Freedman, Gilles, Edan, Hans-Peter, Hartung, David H, Miller, Xavier, Montalbán, Frederick, Barkhof, Krzysztof, Selmaj, Bernard M J, Uitdehaag, Susanne, Dahms, Lars, Bauer, Christoph, Pohl, Rupert, Sandbrink, S, Howell
Přispěvatelé: UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Neurology, Radiology and nuclear medicine, Epidemiology and Data Science, Neuroscience Campus Amsterdam 2008, Dubois, Bénédicte, VU University medical center
Rok vydání: 2007
Předmět:
Central Nervous System
Male
Placebo-controlled study
clinically isolated syndromes
multicenter
Gastroenterology
Placebos
placebo-controlled trial
Risk Factors
Clinically isolated syndrome
Age Factors
Magnetic Resonance Imaging
Treatment Outcome
Neurology
Disease Progression
Population study
Biological Markers
Female
Steroids
double-blind
demyelinating event
Interferon beta-1b
Adult
cis
medicine.medical_specialty
Multiple Sclerosis
Placebo
Central nervous system disease
Double-Blind Method
Internal medicine
medicine
Humans
Risk factor
imaging criteria
mri
Autoantibodies
optic neuritis
business.industry
Multiple sclerosis
Interferon-beta
medicine.disease
Placebo Effect
Surgery
predict conversion
mri criteria
Early Diagnosis
progressive multiple-sclerosis
Neurology (clinical)
Age of onset
business
Biomarkers
Zdroj: Journal of neurology, Vol. 255, no.4, p. 480-7 (2008)
Journal of Neurology, 255(4), 480-487. D. Steinkopff-Verlag
Polman, C, Kappos, L, Freedman, M, Edan, G, Hartung, H P, Miller, D H, Montalbán, X, Barkhof, F, Selmaj, K, Uitdehaag, B, Dahms, S, Bauer, L, Pohl, C & Sandbrink, R 2007, ' Subgroups of the BENEFIT study: Risk of developing MS and treatment effect of interferon beta-1b ', Journal of Neurology .
Journal of Neurology. D. Steinkopff-Verlag
Polman, C H, Kappos, L, Freedman, M S, Edan, G, Hartung, H P, Miller, D H, Montalban, X, Barkhof, F, Selmaj, K, Uitdehaag, B M J, Dahms, S, Bauer, L, Pohl, C & Sandbrink, R 2008, ' Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b ', Journal of Neurology, vol. 255, no. 4, pp. 480-487 . https://doi.org/10.1007/s00415-007-0733-2
ISSN: 0340-5354
DOI: 10.1007/s00415-007-0733-2
Popis: 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 (< 30 years: 60%), were cerebrospinal fluid (CSF)-positive (49 %), or had received steroid treatment (48 %). MRI parameters implied a higher risk in placebo-treated patients with > 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%; < 9 T2-lesions: 60%; no Gd-lesions: 57%) and patients without steroid treatment for the CIS (62 %). Monofocal patients had greater treatment effects if they had > 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. ispartof: Journal of neurology vol:255 issue:4 pages:480-487 ispartof: location:Germany status: published
Databáze: OpenAIRE
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