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Multiple sclerosis patients had fewer relapses with immediate treatment of clinically isolated disease but no improvement in disability outcomes, data from a randomized trial showed.
Patients who received immediate treatment with interferon had a 36% lower 10-year odds for progression to clinically definite MS and lower relapse rates at five and 10 years.
However, disability scores, MRI-visible lesions, and the rate of progressive disease at 10 years all did not differ between patients randomized to immediate or delayed treatment.
The findings are consistent with the previously reported five-year results of the trial, investigators reported online in Archives of Neurology.
“Overall, annualized relapse rates were low in both groups, and there was no difference in standard MRI outcomes at either five or 10 years,” wrote R. Philip Kinkel, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues.
“These results suggest that immediate initiation of intramuscular interferon beta-1a in high-risk patients who had a clinically isolated syndrome delays the development of clinically definite MS but has only a modest effect on subsequent relapses and no significant effect on new MRI T2-weighted lesions compared with a randomized group that delayed the onset of therapy.”
The CHAMPS (Controlled High-Risk Avonex Multiple Sclerosis Prevention Study) trial was the first to demonstrate the benefit of disease-modifying therapy in patients with clinically isolated MS (N Engl J Med. 2000; 343: 898-904).
The CHAMPIONS (CHAMPS In Ongoing Neurological Surveillance) trial continued follow-up in CHAMPS patients to see whether the benefits of early treatment persisted over time compared with patients randomized to delayed therapy.
The five-year follow-up data from CHAMPIONS showed a lower rate of clinically definitive MS in the immediate-therapy group, but few patients in either group developed significant disability.
Follow-up in CHAMPIONS continued for 10 years, providing the basis for the analysis and report by Kinkel and colleagues.
Upon completion of CHAMPS, study participants were informed of the results and offered the opportunity to participate in CHAMPIONS without knowledge of their treatment assignment during the CHAMPS trial.
All patients enrolled in CHAMPIONS were offered weekly treatment with interferon beta-1a, but were not required to accept treatment.
The 10-year analysis included 81 patients originally randomized to immediate therapy and 74 originally assigned to delayed treatment. The immediate-treatment group started interferon beta-1a within 30 days of enrollment, whereas the median time to the start of delayed treatment was 30 months.
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