Requested DocAlert: Early Treatment of MS: Eleven-Year Outcomes of the BENEFIT Trial

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Eleven-Year Outcomes in the Early Treatment of MS

Early treatment reduced long-term relapse rates.

The BENEFIT trial was a 2-year, randomized, placebo-controlled, multicenter, manufacturer-funded study to evaluate interferon β-1b (IFN) for the prevention of a second clinical relapse in patients with an initial demyelinating event and abnormal brain [magnetic] resonance imaging indicating possible multiple sclerosis (MS). Placebo recipients (delayed-treatment group) were provided the option to receive IFN open-label upon having a second clinical event or after completion of 2 years of follow-up. Of the original 468 randomized patients, 278 (59%) underwent regular assessments available for analyses. Of these, 167 had received early treatment and 111 had delayed treatment.

With early versus delayed treatment, a second clinical event occurred an average of 2.7 years later. Relapse rates were 19% lower in the early-treatment group, an effect that was sustained even after the delayed-treatment group started therapy. Only 25 patients converted to secondary progressive MS (SPMS) by 11 years, with a nonsignificant trend favoring early treatment (4.5% vs. 8.3%; P=0.5). Disability scores remained low and comparable between the groups, as were patient self-report and quality-of-life scores. An early, small (1 point out of 60) improvement in paced auditory serial addition test scores within the early treatment group was sustained throughout the 11 years (P=0.007).


Early use of IFN was associated with improved relapse rates compared with delayed treatment in this follow-up of the BENEFIT trial. Even after the delayed-treatment group started, the difference persisted for 7 of the 9 years of follow-up. Other trials of clinically isolated syndrome showed a similar effect with early treatment, which may be due to early reduction and alteration of inflammatory parameters. Caveats include the open-label design and incomplete ascertainment in this study. However, the progression of MS in this [millennium], when treated early, appears to be considerably more favorable than suggested by historic epidemiologic studies. Rates of conversion to SPMS were low among both groups, and <10% required a cane to ambulate by 11 years.

Robert T. Naismith, MD reviewing Kappos L et al. Neurology 2016 Aug 10.

Dr. Naismith has received a consulting honorarium from the manufacturer of interferon β-1b.


Kappos L et al. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology 2016 Aug 10; [e-pub].
[Free full-text Neurology article PDF | PubMed® abstract]

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