Fast track — ArticlesEffect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study
Introduction
Three multicentre, placebo-controlled studies have shown that treatment of patients with a first episode of neurological symptoms (also called clinically isolated syndrome) highly suggestive of multiple sclerosis (MS) with interferon beta delays conversion to clinically definite MS (CDMS).1, 2, 3, 4 Furthermore, neuropathological findings suggest the potential for immunomodulatory treatment of MS to have a greater effect early in the disease course, by early inhibition of the cascade of events that leads to irreversible axonal damage and disability.5, 6, 7 However, until now, there has been no controlled evidence showing that treatment with interferon beta initiated early after the first event has an effect on the development of confirmed disability as compared with delayed treatment. The Betaferon/Betaseron in Newly Emerging multiple sclerosis For Initial Treatment (BENEFIT) study, assessing interferon beta-1b in patients with a first event suggestive of MS, was designed to address this issue. Here, we present the results of the preplanned 3-year analysis of BENEFIT.
Section snippets
Patients and procedures
The BENEFIT study consisted of a placebo-controlled phase and a follow-up phase. The 2-year double-blinded, placebo-controlled phase, which was completed in 2005,3 assessed the safety, tolerability, and efficacy of interferon beta-1b 250 μg (8 MIU) subcutaneously every other day in patients with a first event suggestive of MS. Eligible patients had experienced a first neurological event suggestive of MS and had at least two clinically silent lesions on a T2-weighted brain magnetic resonance
Results
Figure 1 shows the trial profile. 418 (89%) of the 468 patients who had started placebo-controlled treatment chose to enter the follow-up phase; 378 of these individuals opted for follow-up treatment with interferon beta-1b 250 μg subcutaneously every other day. 392 (84%) completed 3 years' follow-up; 343 of those who had opted for further treatment were still on interferon beta-1b at this time. The median exposure time to interferon beta-1b over the 3-year period was 1080 days (IQR 854–1093)
Discussion
We found a beneficial effect of early treatment with interferon beta-1b (250 μg, every other day, subcutaneously) on 6-month confirmed EDSS progression 3 years after the first event suggestive of MS, indicating that a delay of such treatment by, essentially, just one event, even at this early stage of the disease, has an effect on later accumulation of disability. Even though most patients in both groups remained at a low level of disability 3 years after the initial event, the delay in
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