Long-term BENEFIT of early MS treatment confirmed
medwireNews: The 11-year follow-up results of the BENEFIT trial emphasize the importance of initiating treatment early in individuals exhibiting the signs of multiple sclerosis (MS) onset, say researchers who observed long-lasting improvements in disease progression and disability.
In the phase III BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) trial, patients with clinically isolated syndrome (CIS) were randomly allocated to receive either interferon beta-1b (250 µg) or placebo every other day within 60 days of CIS diagnosis. Participants in the placebo group could receive interferon beta-1b or another disease-modifying therapy either after 2 years or conversion to clinically definite MS.
Of the 468 individuals originally enrolled, 278 (59.4%) were available for assessment 11 years after randomisation and were included in this current analysis, which found that the risk of progression to clinically definite MS remained a significant 33% lower for those in the early- versus the delayed-treatment groups.
Early treatment with interferon beta-1b also significantly prolonged the time to first relapse, at a median of 1888 days compared with 931 days for the placebo group, and led to a lower overall annualised relapse rate (ARR), at 0.21 versus 0.26, although the latter was mainly driven by between-group differences in the first year of the core study.
Altogether 5.9% of patients developed secondary progressive MS, with a numerically lower proportion in the early- compared with the delayed-treatment arm (4.5 vs 8.3%), but the difference was not significant.
The groups were also comparable with respect to the Expanded Disability Status Scale scores, which remained “low and stable” at year 11, with a median score of 2.0 and median decrease from baseline of 0.5 in both groups, the team reports in Neurology.
Among the battery of assessments that the participants underwent, only Paced Auditory Serial Addition Task–3 total scores (adjusted for baseline) differed significantly between treatment arms, favouring the early-treatment group. Results of other evaluations, including magnetic resonance imaging, were similar regardless of treatment timing.
After 11 years of follow-up, “[e]mployment rates remained high, and health resource utilization tended to be low in both groups”, Ludwig Kappos (University Hospital Basel, Switzerland) and co-authors observe.
They add that their findings provide “Class IV evidence” supporting early treatment with interferon beta-1b, which “had a long-lasting, even remote, beneficial effect on disease activity as well as cognitive outcomes, resource utilization, and employment rate.”
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