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Association Between Immediate Initiation of Intramuscular Interferon Beta-1a at the Time of a Clinically Isolated Syndrome and Long-term Outcomes: A 10-Year Follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance.
MedLine Citation:
PMID:  21987393     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To determine whether immediate initiation of treatment at the time of a clinically isolated syndrome in patients at high risk for clinically definite multiple sclerosis alters disease course over 10 years. DESIGN: Prospective follow-up study. SETTING: Twenty-four Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) sites in the United States and Canada. PARTICIPANTS: A total of 81 patients originally randomly assigned to receive intramuscular interferon beta-1a (the immediate-treatment group) and 74 patients originally randomly assigned to receive placebo (the delayed-treatment group). All patients were from CHAMPS. Intervention  For the immediate-treatment group, treatment was initiated within a month after the onset of a clinically isolated syndrome, and for the delayed-treatment group, treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization. MAIN OUTCOME MEASURES: Rate of developing clinically definite multiple sclerosis, annualized relapse rate, disease course classification, disability measures, and magnetic resonance imaging measures. RESULTS: The immediate-treatment group showed a lower 10-year rate of clinically definite multiple sclerosis (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P = .004) and a lower annualized relapse rate between years 5 and 10 (P = .03). There was no differential effect on disability, magnetic resonance imaging T2-weighted lesions, or the proportion of patients developing progressive disease at 10 years. Few patients reached the Expanded Disability Status Scale milestone scores of 4.0 or greater (9% of patients) or 6.0 or greater (6% of patients). CONCLUSIONS: Immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome in high-risk patients reduces relapse rates over 10 years but does not improve disability outcomes compared with a control group that also initiated therapy relatively early in the disease course. Trial Registration  clinicaltrials.gov Identifier: NCT00179478.
Authors:
R Philip Kinkel; Mariya Dontchev; Craig Kollman; Thomai T Skaramagas; Paul W O'Connor; Jack H Simon;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-10-10
Journal Detail:
Title:  Archives of neurology     Volume:  -     ISSN:  1538-3687     ISO Abbreviation:  -     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372436     Medline TA:  Arch Neurol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (Dr Kinkel); Jaeb Center for Health Research, Tampa, Florida (Ms Dontchev and Dr Kollman); Cleveland Clinic Foundation, Ohio (Ms Skaramagas); St Michael's Hospital, Toronto, Ontario, Canada (Dr O'Connor); and Portland Veterans Affairs Medical Center, Oregon (Dr Simon).
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