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Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.

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Title: Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.
Authors: Kappos L (AUTHOR), Freedman MS (AUTHOR), Polman CH (AUTHOR), Edan G (AUTHOR), Hartung HP (AUTHOR), Miller DH (AUTHOR), Montalbán X (AUTHOR), Barkhof F (AUTHOR), Radü EW (AUTHOR), Bauer L (AUTHOR), Dahms S (AUTHOR), Lanius V (AUTHOR), Pohl C (AUTHOR), Sandbrink R (AUTHOR), BENEFIT Study Group (CORPORATE AUTHOR), Kappos, Ludwig (AUTHOR), Freedman, Mark S (AUTHOR), Polman, Chris H (AUTHOR), Edan, Gilles (AUTHOR), Hartung, Hans-Peter (AUTHOR)
Source: Lancet. 8/4/2007, Vol. 370 Issue 9585, p389-397. 9p.
Abstract: Background: Several controlled studies provide evidence that treatment with interferon beta in patients with a first event suggestive of multiple sclerosis (MS) delays conversion to clinically definite MS (CDMS). Our aim was to determine whether early initiation of treatment with interferon beta prevents development of confirmed disability in MS.Methods: In the initial placebo-controlled phase of the double-blinded BENEFIT study, patients with a first event suggestive of MS and a minimum of two clinically silent lesions in MRI were randomised to receive either interferon beta-1b 250 microg (n=292) or placebo (n=176) subcutaneously every other day for 2 years, or until diagnosis of CDMS. Patients were then eligible to enter the follow-up phase with open-label interferon beta-1b. In the current prospectively planned analysis 3 years after randomisation, the effects of early interferon beta-1b treatment were compared with those of delayed treatment initiated after diagnosis of CDMS or after 2 years on the study. The primary outcomes of this ITT analysis were time to diagnosis of CDMS, time to confirmed expanded disability status scale (EDSS) progression, and score on a patient-reported functional assessment scale (FAMS-TOI). This trial is registered with ClinicalTrials.gov, number NCT00185211.Findings: Of the 468 patients originally randomised, 418 (89%) entered the follow-up phase; 392 (84%) completed 3 years' post-randomisation follow-up. After 3 years, 99 (37%) patients in the early group developed CDMS compared with 85 (51%) patients in the delayed treatment group. Early treatment reduced the risk of CDMS by 41% (hazard ratio 0.59, 95% CI 0.44-0.80; p=0.0011; absolute risk reduction 14%) compared with delayed treatment. Over 3 years, 42 (16%) patients in the early group and 40 (24%) in the delayed group had confirmed EDSS progression; early treatment reduced the risk for progression of disability by 40% compared with delayed treatment (0.60, 0.39-0.92; p=0.022; absolute risk reduction 8%). The FAMS-TOI score was high and stable in both groups over the 3-year period (p=0.31).Interpretation: Our data suggest that early initiation of treatment with interferon beta-1b prevents the development of confirmed disability, supporting its use after the first manifestation of relapsing-remitting MS. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.
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  Data: <searchLink fieldCode="AR" term="%22Kappos+L%22">Kappos L</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Freedman+MS%22">Freedman MS</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Polman+CH%22">Polman CH</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Edan+G%22">Edan G</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hartung+HP%22">Hartung HP</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Miller+DH%22">Miller DH</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Montalbán+X%22">Montalbán X</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Barkhof+F%22">Barkhof F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Radü+EW%22">Radü EW</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bauer+L%22">Bauer L</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dahms+S%22">Dahms S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lanius+V%22">Lanius V</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pohl+C%22">Pohl C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sandbrink+R%22">Sandbrink R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22BENEFIT+Study+Group%22">BENEFIT Study Group</searchLink> (CORPORATE AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kappos%2C+Ludwig%22">Kappos, Ludwig</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Freedman%2C+Mark+S%22">Freedman, Mark S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Polman%2C+Chris+H%22">Polman, Chris H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Edan%2C+Gilles%22">Edan, Gilles</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hartung%2C+Hans-Peter%22">Hartung, Hans-Peter</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 8/4/2007, Vol. 370 Issue 9585, p389-397. 9p.
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  Data: <bold>Background: </bold>Several controlled studies provide evidence that treatment with interferon beta in patients with a first event suggestive of multiple sclerosis (MS) delays conversion to clinically definite MS (CDMS). Our aim was to determine whether early initiation of treatment with interferon beta prevents development of confirmed disability in MS.<bold>Methods: </bold>In the initial placebo-controlled phase of the double-blinded BENEFIT study, patients with a first event suggestive of MS and a minimum of two clinically silent lesions in MRI were randomised to receive either interferon beta-1b 250 microg (n=292) or placebo (n=176) subcutaneously every other day for 2 years, or until diagnosis of CDMS. Patients were then eligible to enter the follow-up phase with open-label interferon beta-1b. In the current prospectively planned analysis 3 years after randomisation, the effects of early interferon beta-1b treatment were compared with those of delayed treatment initiated after diagnosis of CDMS or after 2 years on the study. The primary outcomes of this ITT analysis were time to diagnosis of CDMS, time to confirmed expanded disability status scale (EDSS) progression, and score on a patient-reported functional assessment scale (FAMS-TOI). This trial is registered with ClinicalTrials.gov, number NCT00185211.<bold>Findings: </bold>Of the 468 patients originally randomised, 418 (89%) entered the follow-up phase; 392 (84%) completed 3 years' post-randomisation follow-up. After 3 years, 99 (37%) patients in the early group developed CDMS compared with 85 (51%) patients in the delayed treatment group. Early treatment reduced the risk of CDMS by 41% (hazard ratio 0.59, 95% CI 0.44-0.80; p=0.0011; absolute risk reduction 14%) compared with delayed treatment. Over 3 years, 42 (16%) patients in the early group and 40 (24%) in the delayed group had confirmed EDSS progression; early treatment reduced the risk for progression of disability by 40% compared with delayed treatment (0.60, 0.39-0.92; p=0.022; absolute risk reduction 8%). The FAMS-TOI score was high and stable in both groups over the 3-year period (p=0.31).<bold>Interpretation: </bold>Our data suggest that early initiation of treatment with interferon beta-1b prevents the development of confirmed disability, supporting its use after the first manifestation of relapsing-remitting MS. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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