Effect of early interferon treatment on conversion to definite multiple sclerosis

A randomised study

Giancarlo Comi, Massimo Filippi, Frederik Barkhof, Luca Durelli, Gilles Edan, Oscar Fernández, Hans Peter Hartung, Pierrette Seeldrayers, Per Soelberg Sørensen, Marco Rovaris, Vittorio Martinelli, Otto R. Hommes

Research output: Contribution to journalArticle

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Abstract

Background: Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis. Methods: Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 μg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections. Findings: 241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0·047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0·034). The annual relapse rates were 0·33 and 0·43 (p=0·045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment. Interpretation: Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.

Original languageEnglish
Pages (from-to)1576-1582
Number of pages7
JournalLancet
Volume357
Issue number9268
DOIs
Publication statusPublished - May 19 2001

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Interferons
Multiple Sclerosis
Magnetic Resonance Imaging
Placebos
Therapeutics
Recurrence
Interferon-beta
Brain
Injections
Interferon beta-1a

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of early interferon treatment on conversion to definite multiple sclerosis : A randomised study. / Comi, Giancarlo; Filippi, Massimo; Barkhof, Frederik; Durelli, Luca; Edan, Gilles; Fernández, Oscar; Hartung, Hans Peter; Seeldrayers, Pierrette; Sørensen, Per Soelberg; Rovaris, Marco; Martinelli, Vittorio; Hommes, Otto R.

In: Lancet, Vol. 357, No. 9268, 19.05.2001, p. 1576-1582.

Research output: Contribution to journalArticle

Comi, G, Filippi, M, Barkhof, F, Durelli, L, Edan, G, Fernández, O, Hartung, HP, Seeldrayers, P, Sørensen, PS, Rovaris, M, Martinelli, V & Hommes, OR 2001, 'Effect of early interferon treatment on conversion to definite multiple sclerosis: A randomised study', Lancet, vol. 357, no. 9268, pp. 1576-1582. https://doi.org/10.1016/S0140-6736(00)04725-5
Comi, Giancarlo ; Filippi, Massimo ; Barkhof, Frederik ; Durelli, Luca ; Edan, Gilles ; Fernández, Oscar ; Hartung, Hans Peter ; Seeldrayers, Pierrette ; Sørensen, Per Soelberg ; Rovaris, Marco ; Martinelli, Vittorio ; Hommes, Otto R. / Effect of early interferon treatment on conversion to definite multiple sclerosis : A randomised study. In: Lancet. 2001 ; Vol. 357, No. 9268. pp. 1576-1582.
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AU - Comi, Giancarlo

AU - Filippi, Massimo

AU - Barkhof, Frederik

AU - Durelli, Luca

AU - Edan, Gilles

AU - Fernández, Oscar

AU - Hartung, Hans Peter

AU - Seeldrayers, Pierrette

AU - Sørensen, Per Soelberg

AU - Rovaris, Marco

AU - Martinelli, Vittorio

AU - Hommes, Otto R.

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N2 - Background: Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis. Methods: Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 μg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections. Findings: 241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0·047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0·034). The annual relapse rates were 0·33 and 0·43 (p=0·045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment. Interpretation: Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.

AB - Background: Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis. Methods: Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 μg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections. Findings: 241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0·047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0·034). The annual relapse rates were 0·33 and 0·43 (p=0·045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment. Interpretation: Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.

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