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Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.

Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D, BENEFIT Study Gro - J. Neurol. Neurosurg. Psychiatr. (2013)

Bottom Line: Cognitive outcomes remained higher in the early treated patients.EDSS remained low over time with a median of 1.5 in both arms.These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.

View Article: PubMed Central - PubMed

Affiliation: University of Rennes, Rennes, France.

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Related in: MedlinePlus

Annualised relapse rate (ARR) by year in the total number of patients observed overall and during each study year. ARR was significantly lower in the early treatment group than in the delayed treatment group over the entire study period as well as in years 1 and 8. ARR was lower among patients in the early treatment than the delayed treatment group for years 1 and 2 (0.233 (95% CI 0.195 to 0.277) vs 0.325 (95% CI 0.268 to 0.392), p=0.0073a; RR=0.705, 95% CI 0.546 to 0.910) and from years 6 to 8 (0.146 (95% CI 0.115 to 0.184)) vs 0.212 (95% CI 0.164 to 0.270); p=0.032a; RR=0.694, 95% CI 0.497 to 0.969). aWald-type χ2 test. Generalised linear Poisson regression model.
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JNNP2013306222F3: Annualised relapse rate (ARR) by year in the total number of patients observed overall and during each study year. ARR was significantly lower in the early treatment group than in the delayed treatment group over the entire study period as well as in years 1 and 8. ARR was lower among patients in the early treatment than the delayed treatment group for years 1 and 2 (0.233 (95% CI 0.195 to 0.277) vs 0.325 (95% CI 0.268 to 0.392), p=0.0073a; RR=0.705, 95% CI 0.546 to 0.910) and from years 6 to 8 (0.146 (95% CI 0.115 to 0.184)) vs 0.212 (95% CI 0.164 to 0.270); p=0.032a; RR=0.694, 95% CI 0.497 to 0.969). aWald-type χ2 test. Generalised linear Poisson regression model.

Mentions: The overall ARR in the 8-year observational period was lower in the early treatment group than in the delayed treatment group (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287); figure 3). According to the generalised linear Poisson regression model, early treatment with IFNB1b reduced the ARR by 22.9% over the 8-year period compared with delayed treatment (risk ratio=0.771 (95% CI 0.659 to 0.903); p=0.0012, Wald-type χ2 test). Additionally, risk of recurrent relapses was reduced by 23.4% with early treatment (HR 0.766, 95% CI 0.589 to 0.998; p=0.048). In a post hoc analysis of ARR data, differences between treatment arms emerged in the first year of the study, with significant differences seen in combined year 1 and 2 relapse rates (early treatment: 0.233 (95% CI 0.195 to 0.277) versus delayed treatment: 0.325 (95% CI 0.268 to 0.392); p=0.0073; Wald-type χ2 test from generalised linear Poisson regression model; RR=0.705, 95% CI 0.546 to 0.910). This difference was maintained when aggregated relapse rates from years 3 to 8 were analysed (early treatment: 0.180 (95% CI 0.157 to 0.205) versus delayed treatment: 0.223 (95% CI 0.190 to 0.260); p=0.037; RR=0.807, 95% CI 0.660 to 0.987).


Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.

Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D, BENEFIT Study Gro - J. Neurol. Neurosurg. Psychiatr. (2013)

Annualised relapse rate (ARR) by year in the total number of patients observed overall and during each study year. ARR was significantly lower in the early treatment group than in the delayed treatment group over the entire study period as well as in years 1 and 8. ARR was lower among patients in the early treatment than the delayed treatment group for years 1 and 2 (0.233 (95% CI 0.195 to 0.277) vs 0.325 (95% CI 0.268 to 0.392), p=0.0073a; RR=0.705, 95% CI 0.546 to 0.910) and from years 6 to 8 (0.146 (95% CI 0.115 to 0.184)) vs 0.212 (95% CI 0.164 to 0.270); p=0.032a; RR=0.694, 95% CI 0.497 to 0.969). aWald-type χ2 test. Generalised linear Poisson regression model.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4215285&req=5

JNNP2013306222F3: Annualised relapse rate (ARR) by year in the total number of patients observed overall and during each study year. ARR was significantly lower in the early treatment group than in the delayed treatment group over the entire study period as well as in years 1 and 8. ARR was lower among patients in the early treatment than the delayed treatment group for years 1 and 2 (0.233 (95% CI 0.195 to 0.277) vs 0.325 (95% CI 0.268 to 0.392), p=0.0073a; RR=0.705, 95% CI 0.546 to 0.910) and from years 6 to 8 (0.146 (95% CI 0.115 to 0.184)) vs 0.212 (95% CI 0.164 to 0.270); p=0.032a; RR=0.694, 95% CI 0.497 to 0.969). aWald-type χ2 test. Generalised linear Poisson regression model.
Mentions: The overall ARR in the 8-year observational period was lower in the early treatment group than in the delayed treatment group (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287); figure 3). According to the generalised linear Poisson regression model, early treatment with IFNB1b reduced the ARR by 22.9% over the 8-year period compared with delayed treatment (risk ratio=0.771 (95% CI 0.659 to 0.903); p=0.0012, Wald-type χ2 test). Additionally, risk of recurrent relapses was reduced by 23.4% with early treatment (HR 0.766, 95% CI 0.589 to 0.998; p=0.048). In a post hoc analysis of ARR data, differences between treatment arms emerged in the first year of the study, with significant differences seen in combined year 1 and 2 relapse rates (early treatment: 0.233 (95% CI 0.195 to 0.277) versus delayed treatment: 0.325 (95% CI 0.268 to 0.392); p=0.0073; Wald-type χ2 test from generalised linear Poisson regression model; RR=0.705, 95% CI 0.546 to 0.910). This difference was maintained when aggregated relapse rates from years 3 to 8 were analysed (early treatment: 0.180 (95% CI 0.157 to 0.205) versus delayed treatment: 0.223 (95% CI 0.190 to 0.260); p=0.037; RR=0.807, 95% CI 0.660 to 0.987).

Bottom Line: Cognitive outcomes remained higher in the early treated patients.EDSS remained low over time with a median of 1.5 in both arms.These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.

View Article: PubMed Central - PubMed

Affiliation: University of Rennes, Rennes, France.

Show MeSH
Related in: MedlinePlus