Professor Ludwig Kappos University Hospital Petersgraben, Basle, Switzerland, and colleagues, as part of the BENEFIT study, did a study of 468 patients who had shown early symptoms of MS. Of these, 292 were randomised to receive 250µg interferon beta-1b and 176 to receive placebo, subcutaneously every other day for two years, or until they were diagnosed with clinically definite multiple sclerosis (CDMS). After diagnosis of CDMS or completion of two-years of treatment, the patients were then eligible to enter a follow-up phase to receive interferon beta-1b treatment.
Of the patients originally enrolled, 89% entered the follow-up phase, while 84% completed the three-years post-randomisation follow up (2 years in initial phase, one year follow up phase). The study measured patients’ disability status using the expanded disability status scale (EDSS) and found that early treatment with interferon beta-1b reduced the risk for progression of disability by 40% compared with delayed treatment. And whilst 51% of patients in the delayed-treatment group developed CDMS, only 37% of the patients who received early treatment with interferon beta-1b developed CDMS. Thus early treatment reduced the risk of developing CDMS by 41%.
The authors conclude: “Our data suggest that early initiation of treatment with interferon-1b prevents the development of confirmed disability, supporting its use after the first manifestation of relapsing-remitting MS.”
In an accompanying Comment, Dr Sean Pittock, Mayo Clinic of Medicine, Rochester, Minnesota, USA, says: “Kappos and colleagues have set a new standard against which future extension trials will be compared.”
He concludes: “The results should, however, be interpreted with care because the magnitude of benefit, although significant, is clinically small. This follow-up should not be misconstrued as evidence for a treat all approach.”
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