Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

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Standard

Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. / Kappos, Ludwig; Freedman, Mark S; Polman, Chris H; Edan, Gilles; Hartung, Hans-Peter; Miller, David H; Montalbán, Xavier; Barkhof, Frederik; Radü, Ernst-Wilhelm; Metzig, Carola; Bauer, Lars; Lanius, Vivian; Sandbrink, Rupert; Pohl, Christoph; Battistini, Jette Lautrup; BENEFIT Study Group.

I: Lancet Neurology Network, Bind 8, Nr. 11, 01.11.2009, s. 987-97.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Kappos, L, Freedman, MS, Polman, CH, Edan, G, Hartung, H-P, Miller, DH, Montalbán, X, Barkhof, F, Radü, E-W, Metzig, C, Bauer, L, Lanius, V, Sandbrink, R, Pohl, C, Battistini, JL & BENEFIT Study Group 2009, 'Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial', Lancet Neurology Network, bind 8, nr. 11, s. 987-97. https://doi.org/10.1016/S1474-4422(09)70237-6

APA

Kappos, L., Freedman, M. S., Polman, C. H., Edan, G., Hartung, H-P., Miller, D. H., Montalbán, X., Barkhof, F., Radü, E-W., Metzig, C., Bauer, L., Lanius, V., Sandbrink, R., Pohl, C., Battistini, J. L., & BENEFIT Study Group (2009). Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurology Network, 8(11), 987-97. https://doi.org/10.1016/S1474-4422(09)70237-6

Vancouver

Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH o.a. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurology Network. 2009 nov. 1;8(11):987-97. https://doi.org/10.1016/S1474-4422(09)70237-6

Author

Kappos, Ludwig ; Freedman, Mark S ; Polman, Chris H ; Edan, Gilles ; Hartung, Hans-Peter ; Miller, David H ; Montalbán, Xavier ; Barkhof, Frederik ; Radü, Ernst-Wilhelm ; Metzig, Carola ; Bauer, Lars ; Lanius, Vivian ; Sandbrink, Rupert ; Pohl, Christoph ; Battistini, Jette Lautrup ; BENEFIT Study Group. / Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. I: Lancet Neurology Network. 2009 ; Bind 8, Nr. 11. s. 987-97.

Bibtex

@article{84b1920b57354361b1476f9309b4a1a0,
title = "Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial",
abstract = "BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment reduced the risk of CDMS by 37% (hazard ratio [HR] 0.63, 95% CI 0.48-0.83; p=0.003) compared with delayed treatment. The risk for confirmed disability progression was not significantly lower in the early treatment group (0.76, 0.52-1.11; p=0.177). At 5 years, median FAMS-TOI scores were 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the favourable long-term safety and tolerability profile support early initiation of treatment with interferon beta-1b, although a delay in treatment by up to 2 years did not affect long-term disability outcomes. FUNDING: Bayer Schering Pharma.",
author = "Ludwig Kappos and Freedman, {Mark S} and Polman, {Chris H} and Gilles Edan and Hans-Peter Hartung and Miller, {David H} and Xavier Montalb{\'a}n and Frederik Barkhof and Ernst-Wilhelm Rad{\"u} and Carola Metzig and Lars Bauer and Vivian Lanius and Rupert Sandbrink and Christoph Pohl and Battistini, {Jette Lautrup} and Fredriksen, {Jette Lautrup}",
note = "Jette Lautrup Battistini (Jette Frederiksen) er med i Study Group. Tilf{\o}jet manuelt i PURE",
year = "2009",
month = nov,
day = "1",
doi = "http://dx.doi.org/10.1016/S1474-4422(09)70237-6",
language = "English",
volume = "8",
pages = "987--97",
journal = "Lancet Neurology Network",
issn = "1470-8582",
publisher = "TheLancet Publishing Group",
number = "11",

}

RIS

TY - JOUR

T1 - Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

AU - Kappos, Ludwig

AU - Freedman, Mark S

AU - Polman, Chris H

AU - Edan, Gilles

AU - Hartung, Hans-Peter

AU - Miller, David H

AU - Montalbán, Xavier

AU - Barkhof, Frederik

AU - Radü, Ernst-Wilhelm

AU - Metzig, Carola

AU - Bauer, Lars

AU - Lanius, Vivian

AU - Sandbrink, Rupert

AU - Pohl, Christoph

AU - Battistini, Jette Lautrup

AU - BENEFIT Study Group

N1 - Jette Lautrup Battistini (Jette Frederiksen) er med i Study Group. Tilføjet manuelt i PURE

PY - 2009/11/1

Y1 - 2009/11/1

N2 - BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment reduced the risk of CDMS by 37% (hazard ratio [HR] 0.63, 95% CI 0.48-0.83; p=0.003) compared with delayed treatment. The risk for confirmed disability progression was not significantly lower in the early treatment group (0.76, 0.52-1.11; p=0.177). At 5 years, median FAMS-TOI scores were 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the favourable long-term safety and tolerability profile support early initiation of treatment with interferon beta-1b, although a delay in treatment by up to 2 years did not affect long-term disability outcomes. FUNDING: Bayer Schering Pharma.

AB - BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment reduced the risk of CDMS by 37% (hazard ratio [HR] 0.63, 95% CI 0.48-0.83; p=0.003) compared with delayed treatment. The risk for confirmed disability progression was not significantly lower in the early treatment group (0.76, 0.52-1.11; p=0.177). At 5 years, median FAMS-TOI scores were 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the favourable long-term safety and tolerability profile support early initiation of treatment with interferon beta-1b, although a delay in treatment by up to 2 years did not affect long-term disability outcomes. FUNDING: Bayer Schering Pharma.

U2 - http://dx.doi.org/10.1016/S1474-4422(09)70237-6

DO - http://dx.doi.org/10.1016/S1474-4422(09)70237-6

M3 - Journal article

VL - 8

SP - 987

EP - 997

JO - Lancet Neurology Network

JF - Lancet Neurology Network

SN - 1470-8582

IS - 11

ER -

ID: 34172400