Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes
Ludwig KapposC. H. PolmanMark S. FreedmanGilles EdanHP HartungD. H. MillerXavier MontalbánFrederik BarkhofLars BauerP. JakobsChristopher PohlRupert Sandbrink
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Abstract:
Objective: To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome). Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 μg subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months. Results: After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group). Conclusions: Interferon beta-1b 250 μg subcutaneously every other day delayed conversion to clinically definite multiple sclerosis, and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.Keywords:
Tolerability
Clinically isolated syndrome
Interferon beta-1b
McDonald criteria
Interferon beta-1a
Interferon beta-1a
Interferon beta-1b
BETA (programming language)
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Clinically isolated syndrome
Clinical endpoint
Interferon beta-1b
Interferon beta-1a
McDonald criteria
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Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomized multicenter study (INCOMIN). Lancet 2002;359:1453–60. A trial was completed comparing the different interferon therapies for multiple sclerosis. The results indicate that interferon β-1b therapy every other day is more effective than weekly interferon β-1a. More patients who received interferon β-1b remained relapse free, and remained free from new T2 lesions on MRI. The differences between the two treatment groups were more significant during the second year.
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Multicenter trial
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Glatiramer acetate
Interferon beta-1a
Interferon beta-1b
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Clinically isolated syndrome
McDonald criteria
Tolerability
Optic neuritis
Interferon beta-1b
Interferon beta-1a
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The BEtaferon®/BEtaseron® in Newly Emerging MS For Initial Treatment (BENEFIT) trial assessed the efficacy of early versus delayed treatment with interferon beta-1b for patients with clinically isolated syndrome (CIS). Patients were randomly assigned to receive either interferon beta-1b 250 μg every other day (early treatment, n = 292) or placebo (delayed treatment, n = 176) for 2 years or until progression to clinically definite multiple sclerosis. Clinical and magnetic resonance imaging (MRI) outcomes were assessed after 2 years (at the end of the placebo-controlled phase) and then again at 3, 5, and 8 years post randomization. MRI assessments were made after 2, 3, and 5 years. The results showed a consistent advantage of early treatment across most clinical and MRI variables, although median Expanded Disability Status Scale scores remained consistently low, with no differences between groups. These findings suggest that early treatment with interferon beta-1b improves long-term outcomes for patients presenting with CIS.
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INTRODUCTION: Beta-interferon treatment reduces number of relapses and probably slows down progression of remitting-relapsing multiple sclerosis (RRMS). The study objective was to compare functional status of RRMS patients on beta-interferon therapy. MATERIALS AND METHODS: Twenty patients (9 males and 11 females ; 35, 75+/-8, 25 years (mean+/-SD age) with RRMS were treated with beta-interferon at University Department of Neurology, Sestre milosrdnice University Hospital: 7 patients were treated with interferon beta 1b (9, 6 MIU every other day) and 13 patients were treated with interferon beta 1a (6 MIU 3 times weekly). Kurtzke's Expanded Disability Status Score (EDSS) was recorded at baseline and six months after initiation of beta-interferon therapy. RESULTS: In interferon beta 1a group average EDSS score before therapy was 3.00 and after six months of therapy it decreased to 2, 92. In interferon beta 1b group average EDSS was 3.07 before therapy and decreased to 3, 00 after six month of treatment The average EDSS score was slightly smaller after six months of beta-interferon treatment in both groups, but the difference did not reach statistical significance (p=0.17 in interferon beta 1a group ; p=0.36 in interferon beta 1b group). There was no statistically significant difference in EDSS score in all patients before and six months after interferon therapy (p=0.083). CONCLUSION: Results of this study, in small group of RRMS patients showed only slight benefit of beta-interferon therapy. However, further research involving larger number of patients is required to get additional information about functional status of multiple sclerosis patients treated with beta-interferon.
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Objective: To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome). Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 μg subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months. Results: After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group). Conclusions: Interferon beta-1b 250 μg subcutaneously every other day delayed conversion to clinically definite multiple sclerosis, and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.
Tolerability
Clinically isolated syndrome
Interferon beta-1b
McDonald criteria
Interferon beta-1a
Cite
Citations (663)
To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome).We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 mug subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months.After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group).Interferon beta-1b 250 mug subcutaneously every other day delayed conversion to clinically definite multiple sclerosis, and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.
Tolerability
Clinically isolated syndrome
Interferon beta-1b
McDonald criteria
Interferon beta-1a
Cite
Citations (129)