The 11-year long-term follow-up study from the randomized BENEFIT CIS trial
Résumé
Objective: To assess outcomes for patients treated with interferon beta-1b immediately after clinically
isolated syndrome (CIS) or after a short delay.
Methods: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment)
were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed
treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on
placebo could switch to interferon beta-1b or another treatment. Eleven years after randomization,
patients were reassessed.
Results: Two hundred seventy-eight (59.4%) of the original 468 patients (71.3% of those eligible at
participating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk of
CDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p 5
0.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931
[253, 3,296]; p50.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p50.0018). Only
25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiple
sclerosis. Expanded Disability Status Scale scores remained low and stable, with no difference
between treatment arms (median [Q1,Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better Paced
Auditory Serial Addition Task–3 total scores (p 5 0.0070). Employment rates remained high, and
health resource utilization tended to be low in both groups.MRI metrics did not differ between groups.
Conclusions: Although the delay in treatment was relatively short, several clinical outcomes
favored earlier treatment. Along with low rates of disability and disease progression in both
groups, this supports the value of treatment at CIS.
NCT01795872.