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 language | English |
|---|---|
| Pages (from-to) | 1576-1582 |
| Number of pages | 7 |
| Journal | Lancet |
| Volume | 357 |
| Issue number | 9268 |
| DOIs | |
| Publication status | Published - May 19 2001 |
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ASJC Scopus subject areas
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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 journal › Article
}
TY - JOUR
T1 - Effect of early interferon treatment on conversion to definite multiple sclerosis
T2 - A randomised study
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.
PY - 2001/5/19
Y1 - 2001/5/19
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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U2 - 10.1016/S0140-6736(00)04725-5
DO - 10.1016/S0140-6736(00)04725-5
M3 - Article
VL - 357
SP - 1576
EP - 1582
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9268
ER -