Long-term data from studies in early MS
The BENEFIT study investigated the use of BETAFERON in early MS [1-5]. 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 11 [1-5]:
Overview of the study design [1-5]
- 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)
Design of the BENEFIT study
BENEFIT-11 study
Eleven years after the initiation of the BENEFIT study, 278 of 468 initially randomized patients were assessed (59.4% 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 [5].
BENEFIT-11 study: Study outcomes
Quality of life
SD: standard deviation
References
- Kappos L et al. Neurology 2006; 67(7): 1242-9. Return to content
- Kappos L et al. Lancet 2007; 370: 389-97. Return to content
- Kappos L et al. Lancet Neurology 2009; 8(11): 987-97. Return to content
- Edan G et al. J Neurol Neurosurg Psychiatry 2014; 85(11): 1183-9. Return to content
- Kappos L et al. Neurology 2016; 87(10): 978-87. Return to content
