Long-term data from studies in early MS


 

The BENEFIT study investigated the use of BETAFERON in early MS [1-6]. The study assessed outcomes for patients treated with BETAFERON either directly after clinically isolated syndrome (CIS) or after a short delay. The BENEFIT study consisted of a 2-year core study and numerous follow-up investigations carried out up to year 15 [1-6]:

 

Overview of the study design [1-6]


 

  • In the placebo-controlled phase, patients with CIS were randomized to BETAFERON or placebo subcutaneously every other day
  • After 2 years or after diagnosis of clinically definite MS (CDMS), all patients were offered open-label BETAFERON treatment for up to 5 years (prospective rater-blinded assessment)
  • After year 5, patients were enrolled in an observational extension study up to year 8
  • At year 11, 59.4% of patients (N=278) from the original BENEFIT cohort were identified, retrieved, and assessed in an interventional study (1 visit)
  • At year 15, 55.8% of patients (N=261) from the original BENEFIT cohort were included in an interventional study (1 visit)
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Design of the BENEFIT study

 

 

BENEFIT-15 study


 

Fifteen years after the initiation of the BENEFIT study, 261 of 468 initially randomized patients were assessed (55.8% of the original cohort). Among the assessed patients, the mean (SD) delay in the start of treatment in the delayed compared to the early treatment group was 1.5 (0.7) years. Therefore, both groups in this study are considered to have started treatment with BETAFERON relatively early in the course of the disease [6].

 

 

 

BENEFIT-15 study: Study outcomes


 

Time to CDMS

Disability

Cognitive test: PASAT

Employment

Quality of life

 

 

SD: standard deviation

 

References

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