• R Philip Kinkel, Craig Kollman, Paul O'Connor, Thomas Jock Murray, Jack Simon, Douglas Arnold, Rohit Bakshi, Bianca Weinstock-Gutman, Staley Brod, Joanna Cooper, Pierre Duquette, Eric Eggenberger, Warren Felton, Robert Fox, Mark Freedman, Steven Galetta, Andrew Goodman, Joseph Guarnaccia, Stanley Hashimoto, Steven Horowitz, Jeffrey Javerbaum, Lloyd Kasper, Michael Kaufman, Lloyd Kerson, Michelle Mass, Kottil Rammohan, Merrell Reiss, Loren Rolak, John Rose, Thomas Scott, John Selhorst, Robert Shin, Craig Smith, William Stuart, Stephen Thurston, Michael Wall, and CHAMPIONS Study Group.
• Neurology. 2006 Mar 14;66(5):678-84.

BackgroundThe Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) showed that IM interferon beta-1a (IFNbeta-1a) significantly slows the rate of development of clinically definite multiple sclerosis (CDMS) over 2 years in high-risk patients who experience a first clinical demyelinating event. This report highlights the primary results of a 5-year, open-label extension of CHAMPS (the Controlled High Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance [CHAMPIONS Study]).ObjectiveTo determine if the benefits of IFNbeta-1a observed in CHAMPS are sustained for up to 5 years.MethodsCHAMPS patients at participating CHAMPIONS sites were enrolled in the study. All patients were offered, but not required to take, IFNbeta-1a 30 microg IM once weekly for up to 5 years (from CHAMPS randomization). Patients who received placebo in CHAMPS were considered the delayed treatment (DT) group, and patients who received IFNbeta-1a in CHAMPS were considered the immediate treatment (IT) group. The primary outcome measure was the rate of development of CDMS. Additional outcomes included disease state classification at 5 years, annualized relapse rates, disability level at 5 years (Expanded Disability Status Scale), and MRI measures at 5 years.ResultsFifty-three percent (203/383) of patients enrolled in CHAMPIONS (n = 100, IT group; n = 103, DT group) and 64% (32/50) of CHAMPS study sites participated in CHAMPIONS. The median time to initiation of IFNbeta-1a therapy in the DT group was 29 months. The cumulative probability of development of CDMS was significantly lower in the IT group compared with the DT group (5-year incidence 36 +/- 9 vs 49 +/- 10%; p = 0.03). Multivariate analysis suggested that the only factors independently associated with an increased rate of development of CDMS were randomization to the DT group and younger age at onset of neurologic symptoms. Few patients in either group developed major disability within 5 years.ConclusionsThese results support the use of IM interferon beta-1a after a first clinical demyelinating event and indicate that there may be modest beneficial effects of immediate treatment compared with delayed initiation of treatment.

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